AzTrials
AzTrials

Cardiovascular DiseasesISCHEMIANCT01471522

International Study of Comparative Health Effectiveness With Medical and Invasive Approaches (ISCHEMIA)

A study testing cardiac catheterization, coronary artery bypass graft surgery and percutaneous coronary intervention in people with Cardiovascular Diseases and Coronary Disease, run by NYU Langone Health at 320 sites in 37 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of the ISCHEMIA trial is to determine the best management strategy for higher-risk patients with stable ischemic heart disease (SIHD). This is a multicenter randomized controlled trial with 5179 randomized participants with moderate or severe ischemia on stress testing. Read more about this study

Who is it for?
Ages 21 years and older
What is being tested?
cardiac catheterization, coronary artery bypass graft surgery and percutaneous coronary intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
5,179 participants
Where
320 sitesin 37 countries
Study dates
Jul 2012to 30 May 2023
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • At least moderate ischemia on a qualifying stress test
  • Participant is willing to comply with all aspects of the protocol, including adherence to the assigned strategy, medical therapy and follow-up visits
  • Participant is willing to give written informed consent
  • Age ≥ 21 years

Who cannot join

  • LVEF < 35%
  • History of unprotected left main stenosis >50% on prior coronary computed tomography angiography (CCTA) or prior cardiac catheterization (if available)
  • Finding of "no obstructive CAD" (<50% stenosis in all major epicardial vessels) on prior CCTA or prior catheterization, performed within 12 months
  • Coronary anatomy unsuitable for either PCI or CABG
  • Unacceptable level of angina despite maximal medical therapy
  • Very dissatisfied with medical management of angina
Show all 28Show fewer
  • History of noncompliance with medical therapy
  • Acute coronary syndrome within the previous 2 months
  • PCI within the previous 12 months
  • Stroke within the previous 6 months or spontaneous intracranial hemorrhage at any time
  • History of ventricular tachycardia requiring therapy for termination, or symptomatic sustained ventricular tachycardia not due to a transient reversible cause
  • NYHA class III-IV heart failure at entry or hospitalization for exacerbation of chronic heart failure within the previous 6 months
  • Non-ischemic dilated or hypertrophic cardiomyopathy
  • End stage renal disease on dialysis or estimated glomerular filtration rate (eGFR) <30mL/min (not an exclusion criterion for CKD ancillary trial, see CKD ancillary trial, Section 18)
  • Severe valvular disease or valvular disease likely to require surgery or percutaneous valve replacement during the trial
  • Allergy to radiographic contrast that cannot be adequately pre-medicated, or any prior anaphylaxis to radiographic contrast
  • Planned major surgery necessitating interruption of dual antiplatelet therapy (note that patients may be eligible after planned surgery)
  • Life expectancy less than the duration of the trial due to non-cardiovascular comorbidity
  • Pregnancy (known to be pregnant; to be confirmed before CCTA and/or randomization, if applicable)
  • Patient who, in the judgment of the patient's physician, is likely to have significant unprotected left main stenosis (Those who are able to undergo CCTA will have visual assessment of the left main coronary artery by the CCTA core lab)
  • Enrolled in a competing trial that involves a non-approved cardiac drug or device
  • Inability to comply with the protocol
  • Exceeds the weight or size limit for CCTA or cardiac catheterization at the site
  • Canadian Cardiovascular Society Class III angina of recent onset, OR angina of any class with a rapidly progressive or accelerating pattern
  • Canadian Cardiovascular Society Class IV angina, including unprovoked rest angina
  • High risk of bleeding which would contraindicate the use of dual antiplatelet therapy
  • Cardiac transplant recipient
  • Prior CABG, unless CABG was performed more than 12 months ago, and coronary anatomy has been demonstrated to be suitable for PCI or repeat CABG to accomplish complete revascularization of ischemic areas (CCC approval required)

Trial locations and contacts

320 sites in 37 countries.

320 sites in 37 countries

United States109 sites

  • Albany Medical Center Hospital

    Albany, New York, 12208

  • Samuel Stratton VA Medical Center of Albany NY

    Albany, New York, 12208

  • Capital Cardiology Associates

    Albany, New York, 12211

  • Asheville Cardiology Associates

    Asheville, North Carolina, 28803

  • Emory University

    Atlanta, Georgia, 30322

  • University of Maryland Medical Center

    Baltimore, Maryland, 21201

  • University of Washington Medical Center

    Bellevue, Washington, 98004

  • NIH Heart Center at Suburban Hospital

    Bethesda, Maryland, 20814

  • Walter Reed National Military Medical Center

    Bethesda, Maryland, 20889

  • Saint Luke's Hospital and Health Network

    Bethlehem, Pennsylvania, 18018

  • Cedars Sinai Medical Center

    Beverly Hills, California, 90211

  • UAB Vascular Biology and Hypertension Program

    Birmingham, Alabama, 35294

  • Brigham & Women's Hospital, Harvard Medical School

    Boston, Massachusetts, 02115

  • Boston Medical Center

    Boston, Massachusetts, 02118

  • NYU-HHC Kings County Hospital Center

    Brooklyn, New York, 11203

  • New York -Presbyterian/Brooklyn Methodist Hospital

    Brooklyn, New York, 11215

  • NYU-HHC Woodhull Hospital

    Brooklyn, New York, 11229

  • Coney Island Hospital

    Brooklyn, New York, 11235

  • Holy Spirit Hospital Cardiovascular Institute

    Camp Hill, Pennsylvania, 17011

  • Cardiovascular Associates, Ltd.

    Chesapeake, Virginia, 23320

  • Cincinnati VA Medical Center

    Cincinnati, Ohio, 45220

  • Louis Stokes Cleveland Veterans Affairs Medical Center

    Cleveland, Ohio, 44106

  • Ohio Health Grant Medical Center

    Columbus, Ohio, 43215

  • NYP Medical Medical Group Hudson Valley Cardiology

    Cortlandt Manor, New York, 10567

  • V.A. North Texas Health Care System

    Dallas, Texas, 75216

  • Midwest Cardiovascular Research Foundation

    Davenport, Iowa, 52803

  • Daytona Heart Group

    Daytona Beach, Florida, 32114

  • Atlanta VA Medical Center

    Decatur, Georgia, 30033

  • Henry Ford Health System

    Detroit, Michigan, 48202

  • Doylestown Health Cardiology

    Doylestown, Pennsylvania, 18901

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • Englewood Hospital and Medical Center

    Englewood, New Jersey, 07631

  • Advanced Heart Care Group

    Fairview Heights, Illinois, 62208

  • Sanford Health

    Fargo, North Dakota, 58122

  • New York University - Langone Cardiovascular Associates

    Flushing, New York, 11355

  • UCSF - Fresno Community Regional Medical Center

    Fresno, California, 93721

  • Malcom Randall VAMC

    Gainesville, Florida, 32608

  • Spectrum Health

    Grand Rapids, Michigan, 49503

  • Baylor College of Medicine

    Houston, Texas, 77030

  • Baylor St. Luke's Medical Center

    Houston, Texas, 77030

  • Houston Heart & Vascular Associates

    Houston, Texas, 77339

  • Indiana University/Krannert Institute of Cardiology

    Indianapolis, Indiana, 46202

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa, 52242

  • Mayo Clinic Florida

    Jacksonville, Florida, 32224

  • Conemaugh Valley Memorial Hospital

    Johnstown, Pennsylvania, 15905

  • Saint Luke's Hospital

    Kansas City, Missouri, 64111

  • Kansas City VA Medical Center

    Kansas City, Missouri, 64128

  • Mid Valley Cardiology

    Kingston, New York, 12401

  • Gundersen Lutheran Medical Center

    La Crosse, Wisconsin, 54601

  • Cardiovascular Specialists of Southwest Louisiana

    Lake Charles, Louisiana, 70601

  • University of Kentucky

    Lexington, Kentucky, 40536

  • Lexington VA Medical Center

    Lexington, Kentucky, 42503

  • South Denver Cardiology Associates, P.C.

    Littleton, Colorado, 80120

  • Ronald Reagan UCLA Medical Center

    Los Angeles, California, 90095

  • University of Louisville

    Louisville, Kentucky, 40292

  • Medical Center of the Rockies

    Loveland, Colorado, 80538

  • Stroobants Cardiovascular Center

    Lynchburg, Virginia, 24501

  • Northwell Health - Manhasset

    Manhasset, New York, 11030

  • Loyola University Medical Center

    Maywood, Illinois, 60153

  • NYU Winthrop

    Mineola, New York, 11501

  • Minneapolis VAMC

    Minneapolis, Minnesota, 55417

  • University of Minnesota

    Minneapolis, Minnesota, 55455

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232

  • Saint Thomas Hospital

    Nashville, Tennessee, 373203

  • VA New York Harbor Health Care System

    New York, New York, 10010

  • Beth Israel Medical Center

    New York, New York, 10016

  • NYU Langone Medical Center-Bellevue Hospital

    New York, New York, 10016

  • NYU New York Medical Associates

    New York, New York, 10022

  • Mount Sinai Saint Luke's Hospital

    New York, New York, 10025

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029

  • Columbia University Medical Center

    New York, New York, 10032

  • University of California Irvine Medical Center

    Orange, California, 92868

  • Palo Alto Medical Foundation Research Institute

    Palo Alto, California, 94087

  • VA Palo Alto HealthCare System

    Palo Alto, California, 94550

  • Baylor Research Institute at Legacy Heart Center

    Plano, Texas, 75024

  • The Heart Hospital Baylor

    Plano, Texas, 75093

  • AtlantiCare Regional Medical Center

    Pomona, New Jersey, 08240

  • Oregon Health & Science University

    Portland, Oregon, 97201

  • Providence Heart and Vascular Institute

    Portland, Oregon, 97225

  • Miriam Hospital

    Providence, Rhode Island, 02906

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • University of Rochester

    Rochester, New York, 14642

  • Hackensack University Medical Center

    Saddle Brook, New Jersey, 07663

  • Covenant Medical Center, Inc.

    Saginaw, Michigan, 01876

  • HealthEast Saint Joseph's Hospital

    Saint Paul, Minnesota, 55102

  • Salt Lake City VA Medical Center

    Salt Lake City, Utah, 84148

  • Audie Murphy V.A.

    San Antonio, Texas, 78229

  • Kaiser Permanente San Jose

    San Jose, California, 94538

  • Coastal Heart Medical Group

    Santa Ana, California, 92704

  • Cardiovascular Center of Sarasota

    Sarasota, Florida, 34239

  • Sarasota Memorial Hospital

    Sarasota, Florida, 34239

  • Cardiology Associates of Schenectady P.C.

    Schenectady, New York, 12309

  • Providence - Providence Park Hospital

    Southfield, Michigan, 48075

  • Stanford University School of Medicine

    Stanford, California, 94305

  • Medicus Alliance Clinical Research Org., Inc.

    Sugar Land, Texas, 77478

  • University of South Florida

    Tampa, Florida, 33606

  • NYU-HHC Lincoln Medical and Mental Health Center

    The Bronx, New York, 10451

  • Jacobi Medical Center

    The Bronx, New York, 10461

  • Torrance Memorial Medical Center

    Torrance, California, 90505

  • Oklahoma Heart Institute

    Tulsa, Oklahoma, 74133

  • Kent Hospital

    Warwick, Rhode Island, 02886

  • VA Connecticut Healthcare System

    West Haven, Connecticut, 06111

  • VA Boston Healthcare System

    West Roxbury, Massachusetts, 02132

  • VAMC-White River Junction

    White River Junction, Vermont, 05009

  • Wichita Falls Heart Clinic

    Wichita Falls, Texas, 76301

  • Winchester Cardiology and Vascular Medicine, PC

    Winchester, Virginia, 22601

  • Saint Vincent Hospital at Worcester Medical Center

    Worcester, Massachusetts, 01608

  • Michigan Heart, PC

    Ypsilanti, Michigan, 48197

  • Yuma Regional Medical Center

    Yuma, Arizona, 85364

Other trials in United States

United Kingdom28 sites

  • Hampshire Hospitals NHS Foundation Trust

    Basingstoke, Hampshire, RG24 9NA

  • Bedford Hospital NHS Trust

    Bedford, Bedfordshire, MK42 9DJ

  • Belfast Trust

    Belfast, Antrim, BT12 6BA

  • South Eastern Health and Social Care

    Belfast, Northern Ireland, BT16 1RH

  • Blackpool Teaching Hospitals

    Blackpool, Lancashire, FY3 8NR

  • Royal Bournemouth Hospital

    Bournemouth, Dorset, BH7 7DW

  • Bradford Royal Infirmary

    Bradford, West Yorkshire, BD9 6RJ

  • Papworth Hospital

    Cambridge, Cambridgeshire, CB23 3RE

  • Broomfield Hospital

    Chelmsford, Essex, CM1 7ET

  • University of Glasgow

    Clydebank, Strathclyde, G81 4DY

  • The University of Hull/Castle Hill Hospital

    Cottingham, East Yorkshire, HU16 5JQ

  • Cardiovascular Research Unit, Craigavon Area Hospital

    Craigavon, Northern Ireland, BT63 5QQ

  • Dorset County Hospital

    Dorchester, Dorset, DT1 2JY

  • Russells Hall Hospital

    Dudley, West Midlands, DY1 2HQ

  • Royal Infirmary of Edinburgh

    Edinburgh, Scotland, EH4 2XU

  • Northwick Park Hospital Harrow/ Royal Brompton Hospital London

    Harrow, Middlesex, HA1 3UJ

  • University College London Hospitals NHS Foundation Trust/Barts Health NHS Trust

    London, EC1A 7BE

  • Royal Free London NHS Foundation Trust

    London, NW3 2QG

  • King's College NHS Foundation Hospital

    London, SE13 6LH

  • Imperial College Healthcare NHS Trust

    London, W12OHS

  • Luton and Dunstable University Hospital NHS FT

    Luton, Berdfordshire, LU4 0DZ

  • Central Manchester University Hospital

    Manchester, M13 9WL

  • The James Cook University Hospital, Middlesbrough

    Middlesbrough, Cleveland, TS4 3BW

  • Nottingham University Hospitals

    Nottingham, Notts, NG5 1PB

  • The Pennine Acute Hospitals NHS Trust

    Oldham, Lancashire, OL1 2JH

  • Peterborough City Hospital

    Peterborough, Cambs, PE3 9GZ

  • Pinderfields Hospital

    Wakefield, West Yorkshire, WF1 4DG

  • Southend University Hospital

    Westcliff-on-Sea, Essex, SS0 0RY

Other trials in United Kingdom

China20 sites

  • Beijing Chao-yang Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100020

  • Chinese Academy of Medical Sciences, Fuwai Hospital

    Beijing, Beijing Municipality, 100037

  • Peking Union Medical College Hospital

    Beijing, Beijing Municipality, 100730

  • Beijing Anzhen Hospital

    Beijing, Chaoyang, 100029

  • Liangxiang Hospital, Beijing Fangshan District

    Beijing, Fangshan, 102401

  • Affiliated Zhongshan Hospital of Dalian University

    Dalian, Liaoning, 116001

  • Guangdong General Hospital

    Guangzhou, Guangdong, 510100

  • The Second Affiliated Hospital Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310009

  • Affiliated Hospital of Jining Medical University

    Jining, Shandong, 272000

  • Qingdao Fuwai Hospital

    Qingdao, Shandong, 266071

  • Shanxi Cardiovascular Hospital

    Taiyuan, Shanxi, 030024

  • Tangshan Gongren Hospital

    Tangshan, Hebei, 063000

  • TEDA International Cardiovascular Hospital

    Tianjing, Tianjing, 300457

  • First Affiliated Hospital of Xinjiang Medical University

    Ürümqi, Xinjiang, 830054

  • Tongji Medical College

    Wuhan, Hubei, 430030

  • Wuhan Asia Heart Hospital

    Wuhan, Hubei

  • Wuhan Union Hospital, Tongji Medical College, Huazhong Science and Tech University

    Wuhan, Hubei

  • Shanxi Provincial People's Hospital

    Xian, Shanxi, 710000

  • The Second Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan, 450014

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan, 450052

Other trials in China

Canada19 sites

  • University of Calgary

    Calgary, Alberta, T2N 2T9

  • University of Alberta

    Edmonton, Alberta, T6G 2B7

  • West Lincoln Memorial Hospital

    Grimsby, Ontario, L3M 1P3

  • Hamilton General Hospital

    Hamilton, Ontario, L8L 2X2

  • London Health Sciences Centre

    London, Ontario, N6A 5A5

  • Dixie Medical Group

    Mississauga, Ontario, L4W 0C2

  • Montreal Heart Institute

    Montreal, Quebec, H1T 1C8

  • Centre Intégré Universitaire de Santé et de Services Sociaux du Montréal

    Montreal, Quebec, H4J 1C5

  • Dr. James Cha

    Oshawa, Ontario, L1J 2K1

  • University of Ottawa Heart Institute

    Ottawa, K1Y 4W7

  • Scarborough Cardiology Research

    Scarborough Village, Ontario, M1E 5E9

  • Saint Catharines General Hospital

    St. Catharines, Ontario, L2S0A9

  • CISSSL - Hopital Pierre-Le Gardeur

    Terrebonne, Quebec, J6V 2H2

  • St. Michael's Hospital

    Toronto, Ontario, M5B 1W8

  • Women's College Hospital

    Toronto, Ontario, M5G 1N8

  • University Health Network

    Toronto, Ontario, M5G 2C4

  • Centre Hospitalier de Regional Trois-Rivieres

    Trois-Rivières, Quebec, G8Z 3R9

  • Vancouver General Hospital

    Vancouver, British Columbia, V5Z 1M9

  • Northwest GTA Cardiovascular and Heart Rhythm Program

    Vaughan, Ontario, L4H0P6

Other trials in Canada

India19 sites

  • Sri Jayadeva Institute of Cardiovascular Sciences and Research

    Bangalore, Karnataka, 560069

  • Government Medical College

    Calicut, Kerala, 673008

  • Apollo Research and Innovation

    Chennai, Tamil Nadu, 600081

  • Gurunanak CARE Hospital

    Hyderabad, Andhra Pradesh, 500020

  • CARE Hospital

    Hyderabad, Andhra Pradesh, 500034

  • CARE Nampally

    Hyderabad, Telangana, 500001

  • Apollo Research & Innovations

    Hyderabad, Telangana, 600081

  • MOSC Medical College Hospital, Kolenchery

    Kolenchery, Kerala, 682311

  • King George's Medical University, Department of Cardiology

    Lucknow, Uttar Pradesh, 226003

  • Hero DMC Heart Institute, Dayanand Medical College and Hospital

    Ludhiana, Punjab, 141001

  • Dr Ram Manohar Lohia Hospital

    New Delhi, National Capital Territory of Delhi, 110001

  • Fortis Escort Heart Institute

    New Delhi, National Capital Territory of Delhi, 110025

  • Batra Hospital and Medical Research Centre (BHMRC)

    New Delhi, National Capital Territory of Delhi, 110062

  • Fortis Healthcare Fl.t Lt. Rajan Dhall Hospital

    New Delhi, National Capital Territory of Delhi, 110070

  • All India Institute of Medical Sciences

    New Delhi, 110029

  • Jawaharlal Institute of Postgraduate Medical Education & Research (JIPMER)

    Pondicherry, Tamil Nadu, 605006

  • Ruby Hall Clinic,Grant Medical Foundation

    Pune, Maharashtra, 411001

  • KEM Hospital Pune

    Pune, Maharashtra, 411011

  • Sree Chitra Tirunal Institute for Medical Sciences and Technology

    Trivandrum, Kerala, 695011

Other trials in India

Brazil17 sites

  • Hospital Lifecenter

    Belo Horizonte, Minas Gerais, 30110-921

  • Hospital Pró-Cardíaco

    Botafogo, Rio de Janeiro, 22280-020

  • Quanta Diagnostico & Terapia

    Curitiba, Paraná, 80045-170

  • Hospital Cardiologico Costantini

    Curitiba, Paraná, 80320-320

  • Hospital Sao Vicente de Paulo

    Fundo, Rio Grande do Sul, 99010080

  • Instituto Dante Pazzanese de Cardiologia

    Ibirapuera, São Paulo, 04012-909

  • Hospital Maternidade e Pronto Socorro Santa Lucia

    Poços de Caldas, Minas Gerais, 37701-045

  • Hospital de Clinicas de Porto Alegre

    Porto Alegre, Rio Grande do Sul, 90035-903

  • Hospital Sao Lucas da Pontificia Universidade Catolica do Rio Grande do Sol

    Porto Alegre, Rio Grande do Sul, 90610-000

  • Instituto de Cardiologia de Porto Alegre

    Porto Alegre, Rio Grande do Sul, 90620-001

  • Hospital das Clinicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo

    Ribeirão Preto, São Paulo, 14048-900

  • Fundacao Bahiana de Cardilogia

    Salvador, Estado de Bahia, 41810-010

  • Hospital da Bahia

    Salvador, BA, 41820-011

  • Hospital TotalCor

    São Paulo, São Paulo, 1418100

  • Unifesp - Hospital Sao Paulo

    São Paulo, 04025-011

  • Heart Institute (InCor) University of São Paulo

    São Paulo, 05403-000

  • Hospital Celso Pierro

    São Paulo, 13059-740

Other trials in Brazil

Italy13 sites

  • Cardiology and CCU - Ospedali Riuniti Ancona

    Ancona, The Marches, 60020

  • Ospedale Regionale Umberto Parini

    Aosta, 11100

  • Azienda Ospedaliera S. Croce e Carle

    Cuneo, Piedmont, 12100

  • Ospedale "G.B. Morgagni - L. Pierantoni" Forli (AUSL della Romagna)

    Forlì, Emilia-Romagna, 47100

  • Policlinico di Monza, Monza MB

    Monza, MB, 20900

  • AORN Dei Colli "V. Monaldi" UOC Cardiologia Università della Campania "L.Vanvitelli"

    Naples, Campania, 80131

  • Clinica Mediterranea

    Naples, 80121

  • University of Padua- Cardiology Clinic

    Padua, Veneto, 35100

  • UO Cardiologia Ospedale SS Cosma e Damiano

    Pescia, Tuscany, 54100

  • Humanitas Research Hospital, Rozzano (MI)

    Rozzano, Milano, 20089

  • IRCCS "Casa Sollievo della Sofferenza"

    San Giovanni Rotondo, FG, 71013

  • Azienda Servizi Sanitaria n.3 Alto Friuli-Collinare-Medio Friuli

    Tolmezzo, Udine, 33028

  • Ospedale di Circolo e Fondazione Macchi

    Varese, 21100

Other trials in Italy

Poland12 sites

  • University Hospital in Bialystok

    Bialystok, Podlaskie Voivodeship, 15-276

  • Department of Coronary Disease, John Paul II Hospital, Jagiellonian University Medical College

    Krakow, Maopolskie, 31-200

  • Cardiology Clinic, Medical University in Lodz

    Lodz, Łódź Voivodeship, 91-425

  • Szpital Kliniczny Przemienienia Pańskiego

    Poznan, 61-848

  • Department of Internal Medicine and Cardiology, Infant Jesus Teaching Hospital, Medical University of Warsaw

    Warsaw, Masovian Voivodeship, 02-005

  • Coronary and Structural Heart Diseases Department, Institute of Cardiology

    Warsaw, Masovian Voivodeship, 04-628

  • Department of Interventional Cardiology & Angiology, Institute of Cardiology

    Warsaw, Masovian Voivodeship, 04-628

  • Medical University of Warsaw

    Warsaw, Masovian Voivodeship, PL-02-097

  • Institute of Cardiology, Warsaw

    Warsaw, Mazovian, 04-628

  • T.Marciniak Hospital

    Wroclaw, Dolny Śląsk, 54-090

  • Military Hospital / Medical University

    Wroclaw, 50-981

  • Medical University of Silesia, School of Medicine with the Division of Dentistry, Department of Cardiology, Congenital Heart Diseases and Electrotherapy, Silesian Center for Heart Diseases

    Zabrze, Silesian Voivodeship, 41-800

Other trials in Poland

Spain9 sites

  • Complexo Hospitalario Universitario A Coruña (CHUAC) Sergas, Department of Cardiology. INIBIC A Coruña. CIBER-CV. Universidad de A Coruña, Spain

    A Coruña, 15008

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 08025

  • Hospital De Bellvitge

    Barcelona, 08907

  • Hospital General Universitario Gregorio Maranon

    Madrid, 28007

  • Hospital La Paz. IdiPaz

    Madrid, 28046

  • HUVA, Hospital Clínico Universitario Virgen De La Arrixaca

    Murcia, 30120

  • Hospital Clinico Universitario de Santiago

    Santiago de Compostela, La Coruna, 15706

  • Hospital Universitario y Politecnico La Fe

    Valencia, 46026

  • Hospital Universitario Miguel Servet

    Zaragoza, 50009

Other trials in Spain

France7 sites

  • Centre Hospitalier Universitaire d'Angers

    Angers, Pays de la Loire Region, 49933

  • Ambroise Pare Hospital

    Boulogne-Billancourt, Île-de-France Region, 92100

  • C.H. Louis Pasteur

    Châtres, Centre-Val de Loire, 28018

  • Antoine-Beclere Hospital

    Clamart, Île-de-France Region, 92141

  • Centre Hospitalier Sud Francilien

    Corbeil-Essonnes, Île-de-France Region, 91100

  • Grenoble University Hospital

    Grenoble, Isere, 38700

  • Bichat Hospital

    Paris, Île-de-France Region, 75018

Other trials in France

Serbia7 sites

  • Clinical Center of Serbia

    Belgrade, 11000

  • Faculty of Medicine, University of Belgrade; Cardiology Clinic, Clinical Center of Serbia

    Belgrade, 11000

  • University Clinical Hospital Zvezdara

    Belgrade, 11000

  • University Hospital Center Bezanijska Kosa

    Belgrade, 11000

  • Institute of Cardiovascular Diseases Vojvodina, Sremska Kamenica, Serbia and Faculty of Medicine, University of Novi Sad

    Kamenitz, Vojvodina, 21204

  • Clinical Center Kragujevac

    Kragujevac, 11000

  • Clinic for Cardiovascular Diseases, Clinical Center Nis

    Niš, 18000

Other trials in Serbia

Argentina6 sites

  • Hospital Italiano Regional del Sur Bahia Blanca

    Bahía Blanca, Buenos Aires, 8000

  • Fundacion Favaloro

    Ciudad Autonoma de Buenos Aires, Buenos Aires, C1093AAS

  • Instituto Medico DAMIC

    Córdoba, CBA, 5009

  • Clinica Del Prado

    Córdoba, 5000

  • Clinica Romagosa and Clinica De La Familia

    Córdoba, 5000

  • Clínica Privada Vélez Sarsfield

    Córdoba, 5000

Other trials in Argentina

Hungary5 sites

  • Eszszk- Szent Istvan Hospital

    Budapest, 1097

  • Military Hospital, Budapest

    Budapest, 1117

  • Heart and Vascular Center, Semmelweis University

    Budapest, 1122

  • George Gottsegen National Institute of Cardiology

    Budapest, H-1096

  • University of Szeged

    Szeged, Szeged Megyei Varos, 6720

Other trials in Hungary

Australia4 sites

  • Flinders Medical Centre

    Adelaide, South Australia, 5042

  • John Hunter Hospital

    New Lambton Heights, New South Wales, 2305

  • Royal Perth Hospital

    Perth, Western Australia, 6000

  • The Queen Elizabeth Hospital

    Woodville South, South Australia, 5011

Other trials in Australia

Germany4 sites

  • Universitatsklinikum Bonn

    Bonn, North Rhine-Westphalia, 53105

  • Praxisklinik Herz Und Gefaesse

    Dresden, Saxony, D-01099

  • University Hospital Jena

    Jena, Thuringia, 07747

  • Robert-Bosch-Krankenhaus

    Stuttgart, Baden-Wurttemberg, 70376

Other trials in Germany

Russia4 sites

  • National Medical Research Center for Cardiovascuar Surgery

    Moscow, Gorod Moskva, 121552

  • E.Meshalkin National Medical Research Center of the Ministry of Health of the Russian Federation

    Novosibirsk, Novosibirsk Oblast, 630055

  • Federal Almazov North-West Medical Research Centre

    Saint Petersburg, 197341

  • North-Western State Medical University

    Saint Petersburg, 199106

Other trials in Russia

Austria3 sites

  • LKH Graz West Austria

    Graz, Stmk, 8020

  • Medical University of Vienna, Department of Cardiology

    Vienna, State of Vienna, 1090

  • Wilhelminen Hospital Vienna

    Vienna, State of Vienna, A-1160

Other trials in Austria

Japan3 sites

  • Saitama Medical University

    Hidaka, Saitama, 350-0495

  • Keio University Hospital

    Shinjuku-Ku, Tokyo, 160-8582

  • National Cerebral and Cardiovascular Center

    Suita-shi, Osaka, 565-8565

Other trials in Japan

Netherlands3 sites

  • Cardio Research Hartcentrum OLVG

    Amsterdam, North Holland, 1091 AC

  • Radboudumc

    Nijmegen, 6500 HB

  • Isala Klinieken

    Zwolle, 8025 AB

Other trials in Netherlands

Portugal3 sites

  • Hospital de Santa Marta

    Lisbon, 1150-291

  • Santa Maria University Hospital, Cardiology Department, CHLN

    Lisbon, 1649-028

  • Centro Hospitalar de Vila Nova de Gaia/Espinho, EPE

    Vila Nova de Gaia, 4434-502

Other trials in Portugal

Singapore3 sites

  • National University Heart Center Singapore

    Singapore, 119228

  • National Heart Centre Singapore

    Singapore, 169609

  • Tan Tock Seng Hospital

    Singapore, 308433

Other trials in Singapore

Israel2 sites

  • Rambam Medical Center

    Haifa, 31096

  • Assuta Medical Centers

    Tel Aviv, 67891

Other trials in Israel

Mexico2 sites

  • Instituto Mexicano del Seguro Social

    Benito Juárez, Mexico City, 3100

  • Instituto Nacional de Cardiología "Ignacio Chávez"

    Mexico City, Mexico City, 14080

Other trials in Mexico

New Zealand2 sites

  • Auckland City Hospital

    Auckland, 1142

  • Waikato Hospital

    Hamilton, Waikato Region, 3240

Other trials in New Zealand

Romania2 sites

  • Emergency County Hospital Baia Mare

    Baia Mare, 021967

  • Emergency Institute of Cardiovascular Diseases ''Prof. Dr. C. C. Iliescu''

    Bucharest, 022328

Other trials in Romania

Sweden2 sites

  • Karolinska Institutet at Danderyd Hospital

    Stockholm, S-18288

  • Uppsala University

    Uppsala, SE-751 85

Other trials in Sweden

Thailand2 sites

  • Ramathibodi Hospital

    Bangkok, 10400

  • Maharaj Nakorn Chiang Mai Hospital

    Chiang Mai, Meung, 50200

Other trials in Thailand

Belgium1 site

  • University Hospital Leuven

    Leuven, Brabant, 3000

Other trials in Belgium

Egypt1 site

  • Cairo University

    Cairo, 11562

Other trials in Egypt

Lithuania1 site

  • Vilnius University Hospital Santariskes Clinic

    Vilnius, LT-08661

Other trials in Lithuania

Malaysia1 site

  • Institut Jantung Negara

    Kuala Lumpur, Kuala Lumpur, 50400

Other trials in Malaysia

North Macedonia1 site

  • University Clinic of Cardiology

    Skopje, Republic of Macedo, 1000

Other trials in North Macedonia

Peru1 site

  • Instituto Neuro Cardiovascular De Las Americas

    Miraflores, Lima region, 18

Other trials in Peru

Saudi Arabia1 site

  • King AbdulAziz Cardiac Center

    Riyadh, Central Province, 11426

Other trials in Saudi Arabia

South Africa1 site

  • Groote Schuur Hospital / University of Cape Town

    Cape Town, Western Cape, 7945

Other trials in South Africa

Switzerland1 site

  • Cardiocentro

    Lugano, Canton Ticino, 6900

Other trials in Switzerland

Taiwan1 site

  • Mackay Memorial Hospital

    Taipei, 10449

Other trials in Taiwan

About this study

The purpose of the ISCHEMIA trial is to determine the best management strategy for higher-risk patients with stable ischemic heart disease (SIHD). This is a multicenter randomized controlled trial with 5179 randomized participants with moderate or severe ischemia on stress testing. A blinded coronary computed tomography angiogram (CCTA) was performed in most participants with eGFR ≥60 mL/min/1.73m2 to identify and exclude participants with either significant unprotected left main disease (≥50% stenosis) or those without obstructive CAD (<50% stenosis in all major coronary arteries). Of 8518 participants enrolled, those that had insufficient ischemia, ineligible anatomy demonstrated on CCTA or another exclusion criterion, did not go on to randomization. Eligible participants were then assigned at random to a routine invasive strategy (INV) with cardiac catheterization followed by revascularization, if feasible, plus optimal medical therapy (OMT) or to a conservative strategy (CON) of OMT, with cardiac catheterization and revascularization reserved for those who fail OMT.

SPECIFIC AIMS

Read more
  1. Primary Aim The primary aim of the ISCHEMIA trial is to determine whether an initial invasive strategy of cardiac catheterization followed by optimal revascularization, if feasible, in addition to OMT, will reduce the primary composite endpoint of cardiovascular death, nonfatal myocardial infarction, resuscitated cardiac arrest, or hospitalization for unstable angina or heart failure in participants with SIHD and moderate or severe ischemia over an average follow-up of approximately 3.5 years compared with an initial conservative strategy of OMT alone with catheterization reserved for failure of OMT.
  2. Secondary Aims Secondary aims are to determine whether an initial invasive strategy compared to a conservative strategy will improve: 1) the composite of CV death or MI; 2) angina symptoms and quality of life, as assessed by the Seattle Angina Questionnaire; 3) all-cause mortality; 4) net clinical benefit assessed by including stroke in the primary and secondary composite endpoints; and 5) individual components of the composite endpoints.

Condition: Coronary Disease Procedure: Coronary CT Angiogram Procedure: Cardiac catheterization Phase: Phase III per NIH

Condition: Cardiovascular Diseases Procedure: Angioplasty, Transluminal, Percutaneous Coronary, other catheter-based interventions Phase: Phase III per NIH

Condition: Heart Diseases Procedure: Coronary Artery Bypass Surgery Phase: Phase III per NIH

Read the detailed description

BACKGROUND:

Evidence supporting a routine invasive practice paradigm for patients with SIHD is outdated. In strategy trials conducted in the 1970s, coronary artery bypass grafting (CABG) improved survival as compared with no CABG in SIHD patients with high-risk anatomic features. The relevance of these studies today is speculative because contemporary secondary prevention-aspirin, beta-blockers, statins, ACE inhibitors, and lifestyle interventions-were used minimally if at all. Subsequent trials have compared percutaneous coronary intervention (PCI) with medical therapy, as PCI has replaced CABG as the dominant method of revascularization for SIHD. To date, PCI has not been shown to reduce death or myocardial infarction (MI) compared with medical therapy in SIHD patients.

COURAGE and BARI 2D, the two largest trials comparing coronary revascularization vs. medical therapy in SIHD patients, found that among patients selected on the basis of coronary anatomy after cardiac catheterization, an initial management strategy of coronary revascularization (PCI, PCI or CABG, respectively) did not reduce the primary endpoints of death or MI (COURAGE), or death (BARI 2D) compared with OMT alone. These data suggest, but do not prove, that routine cardiac catheterization--which often leads to ad hoc PCI through the diagnostic-therapeutic cascade--may not be required in SIHD patients. However, most patients enrolled in COURAGE and BARI 2D who had ischemia severity documented at baseline had only mild or moderate ischemia, leaving open the question of the appropriate role of cardiac catheterization and revascularization among higher-risk patients with more severe ischemia. Observational data suggest that revascularization of patients with moderate-to-severe ischemia is associated with a lower mortality than medical therapy alone, but such data cannot establish a cause and effect relationship. In clinical practice only about half such patients are referred for cardiac catheterization, indicating equipoise. Furthermore, analysis of outcomes for 468 COURAGE patients with moderate-to-severe ischemia at baseline did not reveal a benefit from PCI. This issue cannot be resolved using available data because all prior SIHD strategy trials enrolled patients after cardiac catheterization, introducing undefined selection biases (e.g., highest risk patients not enrolled) and making translation of study results problematic for clinicians managing patients who have not yet had cardiac catheterization.

A clinical trial in SIHD patients uniformly at higher risk (which could not have been performed before COURAGE and BARI 2D results were available) is needed to inform optimal management for such patients.

DESIGN NARRATIVE, INCLUDING MODIFICATIONS DURING THE TRIAL

Primary Endpoint

A composite of CV death, MI, resuscitated cardiac arrest, or hospitalization for unstable angina or heart failure was proposed as the primary endpoint in the application that was funded by NLHBI, with a secondary endpoint of CV death or MI. Study protocol version 1.0 was finalized on January 18, 2012 after review and approval by the protocol review committee (DSMB) with the primary endpoint specified as the composite of CV death or MI. Regarding the final status of the primary endpoint, the protocol stated:

"To ensure that the primary analysis is well-powered and useful, a prospective plan to allow extending follow-up and/or changing the primary endpoint based on aggregate event rate data will be established prior to the first review of unblinded trial data. At a designated time during the trial, an analysis will be conducted to estimate the overall aggregate primary endpoint event rate and project the final number of observed events. If the estimated unconditional power (i.e. based on aggregate event rate data; not by treatment group) is less than the originally targeted 90%, then one or more of the following options will be considered:

  1. Extend follow-up to allow more events to accrue.
  2. Change the primary endpoint to one that occurs more frequently. The current primary endpoint would become a secondary endpoint. The proposed new primary endpoint would be the composite of CV death, MI, resuscitated cardiac arrest, or hospitalization for unstable angina or heart failure.
  3. Follow the recommendation of an independent advisory panel. An independent advisory panel, separate from the DSMB, will be convened for the purpose of reviewing unconditional power estimates and making a recommendation to the NHLBI Director. Members of this panel will not have access to unblinded data by treatment group or other data that may bias their recommendation." All 5 event types were adjudicated throughout the trial. Study protocol v2.0 (January 2014) allowed ischemia eligibility by non-imaging exercise stress test if more stringent (≥70% stenosis) CCTA criteria were met. The 2016 protocol addendum describes the NHLBI-approved reduction in sample size and extension of recruitment and follow-up due to slower than projected recruitment.

The pre-specified first analysis for monitoring and projecting the final aggregate number of primary endpoint events was conducted in 2015. In 2016, the projected need to increase the power by extending follow-up and elevating the 5-component secondary endpoint to become primary was discussed at Steering Committee and Investigator meetings and communicated by email.

An Independent Advisory Panel convened by NHLBI met in May 2017, and in June 2017 NHLBI approved the Independent Advisory Panel's recommendation to elevate the 5-component secondary endpoint to become primary and retain the 2-component composite as a key secondary endpoint. The panel also recommended extension of follow-up. This was communicated to the Steering Committee and Investigators at August and November 2017 meetings and by email. The last visit date was June 30, 2019.

A statistical plan developed for the Independent Advisory Panel process in 2012 specified that a decision about changing the primary endpoint would be targeted to occur before 75% of the final number of primary endpoint events had accrued. Although the final number of primary endpoint events was unknown during the course of the trial, estimates performed at the time of the Advisory Panel meeting suggested that the ratio of accrued endpoint events to final endpoint events was below 50%. See Maron DJ et al. Am Heart J. 2018 201:124-135. PMC6005768 for additional details about modifications to the trial while it was being conducted.

Analysis of Patients' Health Status as a Key Secondary Endpoint

A key secondary objective of the ISCHEMIA trial is to compare the quality of life outcomes-patients' symptoms, functioning and well-being-between those assigned to an invasive strategy as compared with a conservative strategy. In the protocol, angina frequency and disease-specific quality of life measured by the Seattle Angina Questionnaire (SAQ) Angina Frequency and Quality of Life scales, respectively, are described as the tools that will be used to make this comparative assessment. Recent work has indicated that it is possible to combine the information from the individual domain scores in the SAQ into a new Summary Score that captures the information from the SAQ Angina Frequency, Physical Limitation and Quality of Life scales into a single overall score. The advantages of using a summary score as the primary measure of QOL effects of a therapy are a single primary endpoint comparison rather than two or three (eliminating concerns some may have about multiple comparisons) and a more intuitive holistic (patient-centric) interpretation of the effectiveness results. With these advantages in mind, the ISCHEMIA leadership has agreed that the SAQ Summary Score will be designated as the primary way this outcome for this key secondary endpoint of the ISCHEMIA trial will be analyzed and interpreted, with the individual SAQ scores being used in a secondary, explanatory and descriptive role.

PARTICIPATING COUNTRIES:

North America:

Canada; Mexico; USA

South America:

Argentina; Brazil; Peru

Asia:

China; India; Japan; Malaysia; Singapore; Taiwan; Thailand; Russian Federation

Pacifica:

Australia; New Zealand

Europe:

Austria; Belgium; France; Germany; Hungary; Italy; Lithuania; Macedonia; Netherlands; Poland; Portugal; Romania; Serbia; Spain; Sweden; Switzerland; UK

Middle East:

Egypt; Israel; Saudi Arabia

Africa:

South Africa

Being tested
cardiac catheterization, coronary artery bypass graft surgery, percutaneous coronary intervention, Lifestyle, Medication
Medical subject headings
Cardiovascular Diseases, Coronary Disease, Coronary Artery Disease, Heart Diseases, Myocardial Ischemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • cardiac catheterizationProcedure or surgery

    Also called cath

    Narrowed blood vessels can be opened without surgery using stents or can be bypassed with surgery. To determine which is the best approach for you the doctor needs to look at your blood vessels to see where the narrowings are and how much narrowing there is. This is done by a procedure known as a cardiac catheterization.

  • coronary artery bypass graft surgeryProcedure or surgery

    Also called CABG

    Artery narrowing is bypassed during surgery with a healthy artery or vein from another part of the body. This is known as coronary artery bypass grafting, or CABG (said, "cabbage"). The surgery creates new routes around narrowed and blocked heart arteries. This allows more blood flow to the heart.

  • percutaneous coronary interventionProcedure or surgery

    Also called PCI

    Percutaneous coronary intervention may be done as part of the cardiac catheterization procedure. With this procedure a small, hollow, mesh tube (stent) is inserted into the narrowed part of the artery. The stent pushes the plaque against the artery wall, and opens the vessel to allow better blood flow.

  • LifestyleBehavioural

    Also called Behavior change

    diet, physical activity, smoking cessation

  • MedicationDrug

    Also called Pharmacologic Therapy

    antiplatelet, statin, other lipid lowering, antihypertensive, and anti-ischemic medical therapies

Study groups in NCT01471522
Study groupRoleWhat they receive
Invasive Strategy (INV)Active comparatorRoutine invasive strategy with cardiac catheterization followed by revascularization plus optimal medical therapy.
Receives: Procedure: cardiac catheterization; Procedure: coronary artery bypass graft surgery; Procedure: percutaneous coronary intervention; Behavioral: Lifestyle; Drug: Medication
Conservative StrategyActive comparatorOptimal medical therapy with cardiac catheterization and revascularization reserved for patients with acute coronary syndrome, ischemic heart failure, resuscitated cardiac arrest or refractory symptoms.
Receives: Behavioral: Lifestyle; Drug: Medication

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Primary Composite Outcome: Death From Cardiovascular Causes, Myocardial Infarction, or Hospitalization for Unstable Angina, Heart Failure, or Resuscitated Cardiac Arrest

    Measured: 3.2 year follow-up (median)

  2. Cumulative Event Rate of Primary Composite Outcome (Death From Cardiovascular Causes, Myocardial Infarction, or Hospitalization for Unstable Angina, Heart Failure, or Resuscitated Cardiac Arrest)

    This measure represents the estimated cumulative probability of experiencing the primary endpoint within the indicated timeframe in each treatment group. The interpretation of the measure is similar to Kaplan-Meier event rates. Estimates are expressed as percentages ranging from 0% (endpoint is certain not to occur) to 100% (endpoint is certain to occur).

    Measured: 5 years

  3. Number of Participants That Experienced Death From Cardiovascular Causes or Myocardial Infarction

    Measured: 5 years

  4. Cumulative Event Rate of Death From Cardiovascular Causes or Myocardial Infarction

    This measure represents the estimated cumulative probability of experiencing Death from cardiovascular causes or myocardial infarction within the indicated timeframe in each treatment group. The interpretation of the measure is similar to Kaplan-Meier event rates. Estimates are expressed as percentages ranging from 0% (endpoint is certain not to occur) to 100% (endpoint is certain to occur).

    Measured: 5 years

  5. Number of Participants That Experienced Death From Any Cause

    Measured: 5 years

  6. Cumulative Event Rate of Death From Any Cause

    Measured: 5 years

  7. Number of Participants That Experienced Myocardial Infarction

    Measured: 5 years

  8. Cumulative Event Rate of Myocardial Infarction

    Measured: 5 years

  9. Estimated Difference in Cumulative Event Rate ( %) of Primary Composite Outcome: Invasive Minus Conservative

    The primary composite outcome includes death from cardiovascular causes, myocardial infarction, or hospitalization for unstable angina, heart failure, or resuscitated cardiac arrest.

    Measured: 5 years

  10. Estimated Difference in Cumulative Event Rate of Death From Cardiovascular Causes: Invasive Minus Conservative or Myocardial Infarction Between Invasive and Conservative Strategies

    Measured: 5 years

  11. Estimated Difference in Cumulative Event Rate of Death From Any Cause: Invasive Minus Conservative

    Measured: 5 years

  12. Estimated Difference in Cumulative Event Rate of Myocardial Infarction: Invasive Minus Conservative

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Nov 2011 (estimated)
  2. Study startJul 2012
  3. Primary completion30 Jun 2019
  4. Study completion30 May 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
5,179 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01471522
Sponsor's protocol ID
11-00498
Other IDs
1U01HL105907
Acronym
ISCHEMIA
Status last verified
May 2023
First submitted
10 Nov 2011
Last updated
1 Jun 2023
Data monitoring committee
Yes
Individual data sharing
Yes: Data will be submitted to the NHLBI according to their guidelines within 3 years after the final patient follow-up (June 30, 2019) or 2 years after the main paper of the trial has been published, whichever comes first.

Publications

  • Maron DJ, Stone GW, Berman DS, Mancini GB, Scott TA, Byrne DW, Harrell FE Jr, Shaw LJ, Hachamovitch R, Boden WE, Weintraub WS, Spertus JA. Is cardiac catheterization necessary before initial management of patients with stable ischemic heart disease? Results from a Web-based survey of cardiologists. Am Heart J. 2011 Dec;162(6):1034-1043.e13. doi: 10.1016/j.ahj.2011.09.001.

    PubMed 22137077

  • Phillips LM, Hachamovitch R, Berman DS, Iskandrian AE, Min JK, Picard MH, Kwong RY, Friedrich MG, Scherrer-Crosbie M, Hayes SW, Sharir T, Gosselin G, Mazzanti M, Senior R, Beanlands R, Smanio P, Goyal A, Al-Mallah M, Reynolds H, Stone GW, Maron DJ, Shaw LJ. Lessons learned from MPI and physiologic testing in randomized trials of stable ischemic heart disease: COURAGE, BARI 2D, FAME, and ISCHEMIA. J Nucl Cardiol. 2013 Dec;20(6):969-75. doi: 10.1007/s12350-013-9773-4.

    PubMed 23963599

  • ISCHEMIA Trial Research Group; Maron DJ, Hochman JS, O'Brien SM, Reynolds HR, Boden WE, Stone GW, Bangalore S, Spertus JA, Mark DB, Alexander KP, Shaw L, Berger JS, Ferguson TB Jr, Williams DO, Harrington RA, Rosenberg Y. International Study of Comparative Health Effectiveness with Medical and Invasive Approaches (ISCHEMIA) trial: Rationale and design. Am Heart J. 2018 Jul;201:124-135. doi: 10.1016/j.ahj.2018.04.011. Epub 2018 Apr 21.

    PubMed 29778671

  • Hochman JS, Reynolds HR, Bangalore S, O'Brien SM, Alexander KP, Senior R, Boden WE, Stone GW, Goodman SG, Lopes RD, Lopez-Sendon J, White HD, Maggioni AP, Shaw LJ, Min JK, Picard MH, Berman DS, Chaitman BR, Mark DB, Spertus JA, Cyr DD, Bhargava B, Ruzyllo W, Wander GS, Chernyavskiy AM, Rosenberg YD, Maron DJ; ISCHEMIA Research Group. Baseline Characteristics and Risk Profiles of Participants in the ISCHEMIA Randomized Clinical Trial. JAMA Cardiol. 2019 Mar 1;4(3):273-286. doi: 10.1001/jamacardio.2019.0014.

    PubMed 30810700

  • Phillips LM, Jones PG, Shaw LJ, Mark DB, Berman DS, Kwong RY, Picard MH, Chaitman BR, Min JK, Celutkiene J, Stone GW, Vitola J, Moorthy N, Steg PG, Ong P, Hueb WA, Rezende PC, Hochman JS, Maron DJ, Reynolds HR, Spertus JA; ISCHEMIA Research Group. Health status relationship to ischemia and coronary artery disease severity in the ISCHEMIA trial. Am Heart J. 2026 Aug 25;303:107586. doi: 10.1016/j.ahj.2026.107586. Online ahead of print.

    PubMed 42641674

  • O'Keefe EL, Saxon JT, Cho YJ, Jones PG, Mark DB, Bangalore S, Boden WE, Stone GW, Reynolds HR, Hochman JS, Maron DJ, Spertus JA; ISCHEMIA Research Group. Assessing the Prognostic Value of Serial Seattle Angina Questionnaire Scores in Chronic Coronary Disease. Circ Popul Health Outcomes. 2026 Aug 5:e013063. doi: 10.1161/CIRCOUTCOMES.125.013063. Online ahead of print.

    PubMed 42554061

  • O'Keefe E, Sperry BW, Jones PG, O'Keefe JH, Phillips LM, Reynolds HR, Shaw LJ, Berman DS, Picard MH, Kwong RY, Chaitman BR, Bateman TM, Bangalore S, Maron DJ, Hochman JS, Spertus JA; ISCHEMIA Research Group. Variability in Cardiac Stress Test Interpretation: Agreement Between Enrollment Sites and Core Laboratories in the Global ISCHEMIA Trial. Circ Popul Health Outcomes. 2026 Jul 1:e012920. doi: 10.1161/CIRCOUTCOMES.125.012920. Online ahead of print.

    PubMed 42384892

  • Muller M, Cornwell MG, Rajkumar S, Chen Z, Coit D, Drouard G, Sastourne-Haletou P, Yang H, Raitakari O, Lehtimaki T, Hochman J, Maron DJ, Berger JS, Newman JD, Ruggles KV; ISCHEMIA Biorepository Research Group. Whole blood epigenomic and transcriptomic characterization identifies vulnerable molecular subtypes of chronic coronary disease. Nat Commun. 2026 Jun 16;17(1):7647. doi: 10.1038/s41467-026-73815-5.

    PubMed 42303606

  • Singh A, Brown DL, Jones PG, Fu Z, Reynolds HR, Boden WE, O'Brien SM, Mavromatis K, Poh KK, Ali Z, Stone GW, Bangalore S, Spertus JA, Maron DJ, Hochman JS; ISCHEMIA Research Group. Residual Angina Following Complete Revascularization in the ISCHEMIA Trial: Frequency, Clinical Characteristics, Health Status, and Cardiovascular Outcomes. J Am Heart Assoc. 2026 May 19;15(10):e047355. doi: 10.1161/JAHA.125.047355. Epub 2026 May 14.

    PubMed 42132177

  • Grodzinsky A, Cho YJ, Jones PG, Shaw LJ, Merz CNB, Boden WE, Stone GW, Mark DB, Spertus JA, Maron DJ, Hochman JS, Reynolds HR. Sex differences in coronary disease health Status outcomes: the ISCHEMIA trial. Eur Heart J Qual Care Clin Outcomes. 2026 Aug 11;12(5):765-769. doi: 10.1093/ehjqcco/qcag052.

    PubMed 41978343

  • Navarese EP, Talanas G, Kereiakes DJ, Henry TD, Gasior M, Kalarus Z, Uminska J, Burzotta F, Buffon A, Van Belle E, Wojakowski W, Mizia-Stec K, Smolka G, Hudzik B, Ciesla D, Waksman R, Kubica J, Sangiorgi GM, Farkouh ME, Stone GW, Andreotti F. Mortality score in chronic coronary syndrome: prediction model from the ISCHEMIA trial. Eur J Prev Cardiol. 2026 Mar 11:zwag116. doi: 10.1093/eurjpc/zwag116. Online ahead of print.

    PubMed 41812133

  • Kwong RY, Heydari B, Abbasi S, Mongeon FP, Marcotte F, Friedrich M, Shaw LJ, Xu Y, Anthopolos R, Bekeredjian R, Monti L, Selvanayagam J, Lesiak M, Picard MH, Berman DS, Bangalore S, Spertus JA, Stone GW, Boden WE, Min J, Mancini GBJ, Leipsic J, Budoff M, Hague C, Hochman JS, Maron DJ, Reynolds HR; ISCHEMIA Research Group. Stress Cardiac Magnetic Resonance Ischemia Burden and Cardiovascular Events: Post-Hoc Analysis From the ISCHEMIA Trial. JACC Cardiovasc Imaging. 2026 Mar;19(3):326-341. doi: 10.1016/j.jcmg.2025.10.015. Epub 2025 Dec 5.

    PubMed 41351610

  • Ikemura N, Jones PG, Fu Z, Chan PS, Sherrod CF 4th, Arnold SV, Cohen DJ, Mark DB, Maron DJ, Hochman JS, Spertus JA; ISCHEMIA Research Group. Trajectories of Angina After Initial Invasive vs Conservative Strategy for Chronic Coronary Disease. J Am Coll Cardiol. 2025 Sep 16;86(11):782-793. doi: 10.1016/j.jacc.2025.06.044.

    PubMed 40930615

  • Huded CP, Spertus JA, Jones PG, O'Brien SM, Mark DB, Bangalore S, Stone GW, Williams DO, White HD, Boden WE, Reynolds HR, Hochman JS, Maron DJ; ISCHEMIA Research Group. Health Status Outcomes With Percutaneous Coronary Intervention and Coronary Artery Bypass Grafting in ISCHEMIA. Circulation. 2025 Sep 23;152(12):846-858. doi: 10.1161/CIRCULATIONAHA.125.073591. Epub 2025 Sep 5.

    PubMed 40910165

  • Shaw LJ, Phillips LM, Leipsic J, Broderick S, Mieres JH, Marwick TH, Friedrich MG, Miller T, Lopes RD, Chow B, Cerci R, Blankstein R, DiCarli M, Maron DJ, Hochman JS, Alexander KP, Stone GW, O'Brien S, Chaitman BR, Kwong RY, Picard MH, Berman DS, Reynolds HR; ISCHEMIA Research Group. Comparative Prognosis by Stress ECG and Stress Imaging: Results From the ISCHEMIA Trial. JACC Cardiovasc Imaging. 2025 Sep;18(9):943-955. doi: 10.1016/j.jcmg.2025.03.016. Epub 2025 Jul 9.

    PubMed 40637654

Questions about this trial

What is this clinical trial studying?

A study testing cardiac catheterization, coronary artery bypass graft surgery and percutaneous coronary intervention in people with Cardiovascular Diseases and Coronary Disease, run by NYU Langone Health at 320 sites in 37 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 320 sites in United States, United Kingdom, China, Canada, India and 32 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Jul 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary Composite Outcome: Death From Cardiovascular Causes, Myocardial Infarction, or Hospitalization for Unstable Angina, Heart Failure, or Resuscitated Cardiac Arrest (time frame: 3.2 year follow-up (median)). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01471522, which also lists 53 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2023.

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