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Acute Myocardial InfarctionSILVER-AMINCT01755052

SILVER-AMI: Outcomes in Older Persons With Heart Attacks

An observational study of Acute Myocardial Infarction, run by Yale University at 81 sites in United States.

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

SILVER-AMI is a research study of older persons who are admitted to the hospital with a heart attack. Patients will be interviewed in the hospital and again 6 months later. The researchers will also collect detailed medical record information to understand the effect of heart attacks on older persons. Read more about this study

Who is it for?
Ages 75 years and older
Conditions the study is for
Acute Myocardial Infarction
How many people
3,042 participants
Where
81 sitesUnited States
Study dates
Jan 2013to Jun 2018
Phase
Observational
Are there results?
None posted in the registry

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 75 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Study population: Older adults admitted to the hospital with a heart attack

Who may be able to join

  • Age ≥75 years upon admission to the hospital
  • Elevation of cardiac markers within 24 hours of presentation to the hospital
  • Troponin must rise above the upper limit of normal established by the hospital as a determinate of cardiac injury.
  • Any one of the following:
  • Symptoms of ischemia
  • ECG with ischemic changes
  • Imaging evidence of Infarction
  • Intracoronary thrombus on angiography

Who cannot join

  • Patient transferred from another hospital with a length of stay >48 hours at the referring hospital.
  • Refused Informed Consent
  • Decisional impairment with no legally authorized representative
  • AMI is secondary to chest trauma
  • AMI is secondary to in-patient procedure or surgery
  • History of heart transplant
Show all 13Show fewer
  • Non-English/Non-Spanish speaking
  • Inability to complete interview (e.g. comatose or aphasia)
  • Inability to contact for follow-up (e.g. no access to phone, not living in the country)
  • Currently a prisoner
  • Death prior to enrollment
  • Previously enrolled in SILVER-AMI
  • Troponin elevation is the result of apical ballooning syndrome (i.e., Takotsubo)

Trial locations and contacts

81 sites in 1 country.

81 sites in 1 country

United States81 sites

  • Presbyterian Heart Group

    Albuquerque, New Mexico, 87106

  • University of Michigan Health Systems

    Ann Arbor, Michigan, 48109-1287

  • Mission Medical Associates, Inc. dba Asheville Cardiology Associates

    Asheville, North Carolina, 28803

  • Emory University

    Atlanta, Georgia, 30322

  • University of Colorado

    Aurora, Colorado, 80045

  • Cardiovascular Research Foundation of Louisiana

    Baton Rouge, Louisiana, 70808

  • Saint Alphonsus Regional Medical Center

    Boise, Idaho, 83706

  • Brigham and Women's Hospital, Inc.

    Boston, Massachusetts, 02115

  • Boston Medical Center

    Boston, Massachusetts, 02118

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • Bridgeport Hospital

    Bridgeport, Connecticut, 06610

  • Advanced Heart Care, LLC

    Bridgewater, New Jersey, 08807

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27599

  • Northwestern Memorial Hospital

    Chicago, Illinois, 60611

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • The University Of Chicago

    Chicago, Illinois, 60637

  • Metropolitan Cardiology Consultants

    Coon Rapids, Minnesota, 55433

  • Good Samaritan Hospital, Corvallis

    Corvallis, Oregon, 97330

  • The Danbury Hospital and the Western Connecticut Medical

    Danbury, Connecticut, 06810

  • Oakwood Hospital and Medical Center

    Dearborn, Michigan, 48123

  • Denver Health Medical Center

    Denver, Colorado, 80204

  • Iowa Heart Center

    Des Moines, Iowa, 50314

  • St. John Hospital & Medical Center

    Detroit, Michigan, 48236

  • Doylestown Hospital

    Doylestown, Pennsylvania, 18901

  • Englewood Hospital and Medical Center

    Englewood, New Jersey, 07631

  • Northshore University Health System

    Evanston, Illinois, 60201

  • Sanford Research

    Fargo, North Dakota, 57104

  • Sparks Regional Medical Center

    Fort Smith, Arkansas, 72901

  • Parkview Research Center

    Fort Wayne, Indiana, 46845

  • Spectrum Health Hospitals

    Grand Rapids, Michigan, 49503

  • Bellin Memorial Hospital, Inc.

    Green Bay, Wisconsin, 54301

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601

  • Meritus Medical Center

    Hagerstown, Maryland, 21740

  • Saint Francis Hospital and Medical Center

    Hartford, Connecticut, 06105

  • The Queen's Medical Center

    Honolulu, Hawaii, 96813

  • St Mary's Medical Center

    Huntington, West Virginia, 25702

  • St. Francis Medical Group

    Indianapolis, Indiana, 46237

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa, 52242

  • Mid America Heart Institute St. Luke's Hospital

    Kansas City, Missouri, 64111

  • Nebraska Specialty Network

    Lincoln, Nebraska, 68526

  • Los Alamitos Internal Medical Group

    Los Alamitos, California, 90720

  • Stroobants Cardiovascular Center

    Lynchburg, Virginia, 24501

  • The Corporation of Mercer University

    Macon, Georgia, 31201

  • Aurora Research Institute

    Milwaukee, Wisconsin, 53233

  • Minneapolis Heart Institute Foundation

    Minneapolis, Minnesota, 55407

  • The International Heart Institute of Montana

    Missoula, Montana, 59802

  • Yale University

    New Haven, Connecticut, 06511

  • New York University School of Medicine

    New York, New York, 10016

  • The Trustees of Columbia University in the City of New York

    New York, New York, 10034

  • Sentara Hospital

    Norfolk, Virginia, 23507

  • McLaren Cardiovascular Group

    Okemos, Michigan, 48864

  • Oklahoma Heart Hospital Research Foundation

    Oklahoma City, Oklahoma, 73120

  • CHI-Health-Alegent Creighton Research

    Omaha, Nebraska, 68124

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15261

  • Providence Health & Services

    Portland, Oregon, 97225

  • OHSU: Oregon Health & Science University

    Portland, Oregon, 97239

  • Portland VA Medical Center

    Portland, Oregon, 97239

  • Rhode Island Hospital

    Providence, Rhode Island, 02903

  • Rapid City Regional Hospital, Inc.

    Rapid City, South Dakota, 57701

  • Virginia Commonwealth University

    Richmond, Virginia, 23298

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • St. Francis Research & Educational Corporation

    Roslyn, New York, 11576

  • Mercy General Hospital

    Sacramento, California, 95816

  • Santa Barbara Cottage Hospital

    Santa Barbara, California, 93105

  • Donald Guthrie Foundation for Education and Research

    Sayre, Pennsylvania, 18840

  • Cox Health

    Springfield, Missouri, 65807

  • Washington University

    St Louis, Missouri, 63110

  • St. Joseph's Medical Center

    Stockton, California, 95204

  • The Research Foundation for the State University of New York

    Stony Brook, New York, 11794-8167

  • Overlook Medical Center

    Summit, New Jersey, 07901

  • Florida Hospital Pepin Heart Institute

    Tampa, Florida, 33613

  • Montefiore/Albert Einstein Medical Center

    The Bronx, New York, 10461

  • Torrance Memorial Medical Center

    Torrance, California, 90505

  • Munson Medical Center

    Traverse City, Michigan, 49684

  • South Georgia Medical Center

    Valdosta, Georgia, 31602

  • Providence Healthcare Network

    Waco, Texas, 76712

  • Forsyth Medical Center

    Winston-Salem, North Carolina, 27103

  • Wake Forest University Health Sciences

    Winston-Salem, North Carolina, 27157-1045

  • UMass Memorial Medical Center

    Worcester, Massachusetts, 01605

  • Lankenau Hospital

    Wynnewood, Pennsylvania, 19096

Other trials in United States

About this study

Official title: SILVER-AMI: Risk Stratification in Older Persons With Acute Myocardial Infarction

SILVER-AMI is a research study of older persons who are admitted to the hospital with a heart attack. Patients will be interviewed in the hospital and again 6 months later. The researchers will also collect detailed medical record information to understand the effect of heart attacks on older persons.

The research team at Yale University will use this information to develop a risk model that can be used to help doctors predict recovery. The goal of the study is to help older people in the future make well-informed decisions about their health care during a heart attack.

Read the detailed description

The overall objective of this study is to develop and validate risk stratification tools for older adults who have recently had an Acute Myocardial Infarction (AMI). While there is emerging interest in understanding the role of geriatric conditions as they pertain to cardiovascular outcomes, there is no standard, feasible assessment of older patients with AMI that can stratify their risk of subsequent morbidity and mortality. Currently available risk models are designed solely to predict clinical events (e.g. mortality, reinfarction). This is insufficient for shared decision making with older patients, who consistently rate maintenance of favorable health status as a top priority. This study will address these gaps by melding principles from geriatrics and cardiology to create post-AMI risk models specifically designed for older patients. This study is significant because older persons with AMI are a growing, yet understudied, population.

Dr. Sarwat Chaudhry at Yale University is conducting a multi-center, observational study designed to collect data about the post-AMI recovery period that will be used to generate risk models for older patients with AMI. The intent of the study is to use the knowledge from the data collected in SILVER-AMI to ultimately design interventions to improve the care and outcomes of older patients with AMI.

Study coordinators will screen older patients hospitalized with an AMI. Participants will be assessed at baseline prior to AMI hospital discharge through an interview, physical assessment and medical record review. One follow-up interview will be conducted approximately 6 months later by the Yale Follow-up Center. Clinical outcomes will be assessed for the follow-up period occurring 6 months post AMI hospitalization through self-report and medical record review.

Keywords
Acute Myocardial Infarction, Geriatrics, Cardiology, Aging, Heart Attack, Risk Factors, Quality of Care, Risk Models
Medical subject headings
Myocardial Infarction

What is being measured

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

  1. All-cause hospital readmission

    Measured: up to six months

Secondary outcomes (2)

  1. All-cause mortality

    Measured: Up to six months

  2. Decline in health status

    Measured: up to six months

Timeline

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

  1. First posted21 Dec 2012 (estimated)
  2. Study startJan 2013
  3. Primary completionJun 2018
  4. Study completionJun 2018

Resources

More details

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

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
3,042 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01755052
Sponsor's protocol ID
1205010311
Other IDs
1R01HL115295-01
Acronym
SILVER-AMI
Status last verified
May 2019
First submitted
27 Nov 2012
Last updated
28 May 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Dodson JA, Hajduk AM, Geda M, Krumholz HM, Murphy TE, Tsang S, Tinetti ME, Nanna MG, McNamara R, Gill TM, Chaudhry SI. Predicting 6-Month Mortality for Older Adults Hospitalized With Acute Myocardial Infarction: A Cohort Study. Ann Intern Med. 2020 Jan 7;172(1):12-21. doi: 10.7326/M19-0974. Epub 2019 Dec 10.

    PubMed 31816630

  • Dodson JA, Hajduk AM, Murphy TE, Geda M, Krumholz HM, Tsang S, Nanna MG, Tinetti ME, Goldstein D, Forman DE, Alexander KP, Gill TM, Chaudhry SI. Thirty-Day Readmission Risk Model for Older Adults Hospitalized With Acute Myocardial Infarction. Circ Cardiovasc Qual Outcomes. 2019 May;12(5):e005320. doi: 10.1161/CIRCOUTCOMES.118.005320.

    PubMed 31010300

  • Dodson JA, Geda M, Krumholz HM, Lorenze N, Murphy TE, Allore HG, Charpentier P, Tsang SW, Acampora D, Tinetti ME, Gill TM, Chaudhry SI. Design and rationale of the comprehensive evaluation of risk factors in older patients with AMI (SILVER-AMI) study. BMC Health Serv Res. 2014 Nov 5;14:506. doi: 10.1186/s12913-014-0506-4.

    PubMed 25370536

Questions about this trial

What is this clinical trial studying?

An observational study of Acute Myocardial Infarction, run by Yale University at 81 sites in United States.

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 8 inclusion and 13 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 28 May 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 81 sites in United States. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

All-cause hospital readmission (time frame: up to six months). 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 NCT01755052, which also lists 3 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 28 May 2019.

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