AzTrials
AzTrials

Chronic Ischemic Heart DiseaseSTARTNCT03796741

STable Coronary Artery Diseases RegisTry

An observational study of Chronic Ischemic Heart Disease, run by Heart Care Foundation at 183 sites in Italy.

Completed

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

Official record
Search all trials

Trial summary

Observational, prospective multicentric, national study, evaluating the diagnostic and therapeutic pathways of patient with cronic coronary artery disease followed in Italian cardiology centers. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Ischemic Heart Disease
What is being tested?
Data collection on Stable Ischemic heart disease
How many people
5,070 participants
Where
183 sitesItaly
Study dates
17 Mar 2016to 24 Apr 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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Consecutive patients discharged (after a hospitalization or DH hospitalization) or managed as outpatients in Cardiology department with diagnoses of stable coronary heart disease.

Who may be able to join

  • Patients aged >/= 18
  • Patients discharged from hospital or ambulatory visit with a diagnoses of stable heart disease;
  • Written informed consent

Who cannot join

  • Acute coronary syndrome within 30 days from enrollment
  • CCS Angina Class IV
  • Angina probably not for coronary artery disease

Trial locations and contacts

183 sites in 1 country.

183 sites in 1 country

Italy183 sites

  • Ospedale San Giovanni Di Dio - Uo Cardiologia E Utic

    Agrigento, AG, 92100

  • Ospedale Ss. Vito E Spirito - U.O.S. Di Cardiologia

    Alcamo, TP, 91011

  • Clinica Citta' Di Alessandria - Uo Cardiologia

    Alessandria, 15100

  • Istituto Scientifico Inrca - Uo Cardiologia/Utic/Telecardiologia

    Ancona, AN, 60131

  • Osp. Andria Canosa - Po Andria - Cardiologia - Utic

    Andria, BT, 76123

  • Ospedali Riuniti Anzio-Nettuno - U.O. Di Cardiologia - Utic

    Anzio, RM, 00042

  • Casa Di Cura Citta' Di Aprilia - U.O. Cardiologia

    Aprilia, LT, 04011

  • Nuovo Ospedale Dei Castelli - U.O.C. Di Cardiologia E Utic

    Ariccia, RM, 00040

  • Ospedale Civile - U.O.C. Cardiologia

    Arzignano, VI, 36071

  • Ospedale Gen.Le Prov.Le C.G. Mazzoni - Sc Cardiologia

    Ascoli Piceno, AP, 63100

  • Ospedale E. Muscatello - U.O. Di Cardiologia - Utic

    Augusta, SR, 96011

  • Aorn San Giuseppe Moscati - U.O. Cardiologia/Utic 'D. Rotiroti'

    Avellino, AV, 83100

  • Presidio Ospedaliero Moscati - U.O.C. Cardiologia

    Aversa, CE, 81031

  • Ospedale G. Di Maria - Cardiologia Utic

    Avola, SR, 96012

  • Ospedale San Paolo - Cardiologia-Utic

    Bari, BA, 70123

  • Ospedale Policlinico - U.O. Di Cardiologia Ospedaliera

    Bari, BA, 70124

  • Ospedale Monsignor Angelo R. Di Miccoli - Unita' Operativa Di Cardiologia

    Barletta, BT, 76121

  • Presidio Osped. S. Maria Della Speranza - U.O. Di Cardiologia

    Battipaglia, SA, 84091

  • Ospedale Civile - Sc Cardiologia

    Belluno, BL, 32100

  • Azienda Ospedaliera G. Rummo - Cardiologia Interventistica E Utic

    Benevento, BN, 82100

  • Asst Papa Giovanni Xxiii - Cardiologia 1

    Bergamo, BG, 24127

  • Ospedale Civile Di Boscotrecase - Utic Cardiologia

    Boscotrecase, 80042

  • Ospedale Perrino - U.O.C. Di Cardiologia

    Brindisi, BR, 72100

  • Presidio Ospedaliero Ss Trinita' - Sc Di Cardiologia

    Cagliari, CA, 09121

  • Azienda Ospedaliera G. Brotzu - Struttura Complessa Di Cardiologia

    Cagliari, CA, 09134

  • Ospedale A. Cardarelli - U.O. Cardiologia E Utic

    Campobasso, CB, 86100

  • Ospedale Di Camposampiero - U.O.A. Cardiologia

    Camposampiero, PD, 35012

  • Ospedale Carate Brianza - Cardiologia - Carate Brianza/Giussano

    Carate Brianza, MB, 20048

  • Capt Di Cariati - Ambulatorio Di Cardiologia

    Cariati, CS, 87063

  • Ospedale Civile Oglio Po - U.O. Di Cardiologia-Utic

    Casalmaggiore, CR, 26041

  • Az. Ospedaliera S. Anna E S. Sebastiano - Cardiologia E Riabilit. Cardiologica

    Caserta, CE, 81100

  • Az. Ospedaliera S. Anna E S. Sebastiano - U.O. Cardiologia-Utic

    Caserta, CE, 81100

  • Ics Maugeri Spa Societa' Benefit - Uo Cardiologia

    Cassano delle Murge, BA, 70020

  • Pineta Grande Hospital - U.O. Cardiologia

    Castel Volturno, CE, 81030

  • P.O. Garibaldi-Nesima - U.O.C. Di Cardiologia

    Catania, CT, 95122

  • Ospedale Ss. Annunziata - U.O. Di Cardiologia

    Cento, FE, 44042

  • Ospedale Civile Giuseppe Tatarella - U.O. Di Cardiologia - Utic

    Cerignola, FG, 71042

  • Ospedale M.Bufalini - U.O. Di Cardiologia-Utic

    Cesena, FC, 47023

  • Ospedale Civile - U.O.C. Cardiologia

    Chioggia, VE, 30019

  • Por Cirie'- Lanzo Presidio Cirie' - S.C. Cardiologia Cirie'- Ivrea

    Cirié, TO, 10073

  • Presidio Ospedaliero Citta' Di Castello - U.O. Di Cardiologia

    Città di Castello, PG, 06012

  • Presidio Osp. Di Civitanova Marche - Sc Cardiologia

    Civitanova Marche, MC, 62012

  • Ospedale Civile San Paolo - U.O. Cardiologia - Utic

    Civitavecchia, RM, 00053

  • Ospedale Santa Maria Dei Battuti - U.O. Di Cardiologia

    Conegliano, TV, 31015

  • Ospedale San Giuseppe Da Copertino - U.O. Di Cardiologia-Utic

    Copertino, LE, 73043

  • Ospedale Umberto I - Uosd Di Cardiologia

    Corato, BA, 70033

  • Ospedale Civile San Sebastiano - Sos Cardiologia Area Nord

    Correggio, RE, 42015

  • Ospedale Valdichiana Santa Margherita - Uos Cardiologia E Hdu

    Cortona, AR, 52044

  • Ospedale Annunziata - Uoc Cardiologia

    Cosenza, CS, 87100

  • Ospedale Di Cremona - Uo Di Cardiologia

    Cremona, CR, 26100

  • Ospedale Civile Profili - U.O. Cardiologia

    Fabriano, AN, 60044

  • Ospedale Per Gli Infermi - U.O. Cardiologia - Utic

    Faenza, RA, 48018

  • Ospedale Santa Maria Del Prato - U.O. Di Cardiologia

    Feltre, BL, 32032

  • Ospedale Civile Augusto Murri - U.O. Cardiologia

    Fermo, FM, 63900

  • Arcispedale Sant'Anna - U.O. Cardiologia - Utic

    Ferrara, FE, 44124

  • Ospedali Riuniti - S.C. Di Cardiologia Univ.-Utic

    Foggia, FG, 71100

  • Ospedale Del Dono Svizzero - U.O.C. Di Cardiologia - Utic

    Formia, LT, 04023

  • Ospedale Civile Dario Camberlingo - U.O. Di Cardiologia - Utic

    Francavilla Fontana, BR, 72021

  • Ospedale San Giovanni Di Dio - Uo Cardiologia - Utic

    Frattamaggiore, 80027

  • Ospedale Santa Caterina Novella - U.O. Di Cardiologia

    Galatina, LE, 73013

  • Ospedale S. Antonio Abate - U.O. Di Cardiologia

    Gallarate, VA, 21013

  • Ospedale Civile 'La Memoria' - U.O. Di Cardiologia

    Gavardo, BS, 25085

  • Po Vittorio Emanuele Di Gela - U.O.C Cardiologia - Utic

    Gela, CL, 93012

  • Ospedale Padre Antero Micone - Sc Cardiologia - Utic

    Genova, GE, 16153

  • Ospedale Generale Di Zona - U.O. Cardiologia - Utic

    Giugliano in Campania, 80014

  • Ospedale San Giovanni Di Dio - S.O.C. Cardiologia

    Gorizia, GO, 34170

  • Ospedale Moriggia Pelascini - Unita' Operativa Di Cardiologia

    Gravedona, CO, 22015

  • Ospedale Della Misericordia - U.O. Di Cardiologia

    Grosseto, GR, 58100

  • Ospedale Civile - Sc Cardiologia Area Nord

    Guastalla, RE, 42016

  • Ospedale Di Jesi Carlo Urbani - U.O. Di Cardiologia

    Iesi, AN, 60035

  • Ospedale Civile - U.O. Cardiologia-Utic

    Imperia, IM, 18100

  • Ospedale F. Veneziale - Ssd Cardiologia Emodinamica

    Isernia, IS, 86170

  • Ospedale Civile - S.C. Cardiologia Cirie' Ivrea

    Ivrea, TO, 10015

  • Ospedale Giovanni Paolo Ii - U.O. Cardiologia E Utic

    Lamezia Terme, CZ, 88046

  • Polo Ospedaliero Integrato (C/O Icot) - Uoc Cardiologia Ed Emodinamica Univ.

    Latina, LT, 04100

  • Casa Di Cura Petrucciani - U.O. Cardiologia - Card. Riabilitativa

    Lecce, LE, 73100

  • Ospedale Vito Fazzi - U.O. Card. Interventistica - Emodinamica

    Lecce, LE, 73100

  • Ospedale Vito Fazzi - U.O. Di Cardiologia

    Lecce, LE, 73100

  • Ospedale Civile - Uo Cardiologia

    Legnano, MI, 20025

  • Nuovo Ospedale Versilia - Sc Cardiologia

    Lido di Camaiore, LU, 55043

  • Ospedale Civile - S.O.C. Cardiologia-Utic

    Locri, RC, 89044

  • Ospedale Civile - U.O. Di Cardiologia

    Lugo, RA, 48022

  • Ics Maugeri Spa Societa' Benefit - U.O. Di Cardiologia Riabilitativa

    Lumezzane, BS, 25065

  • Ospedale Civile Fornaroli - U.O. Cardiologia

    Magenta, MI, 20013

  • Ospedale Civile M. Giannuzzi - Cardiologia E Utic

    Manduria, TA, 74024

  • Presidio Ospedaliero Paolo Borsellino - U.O.C Cardiologia- Utic

    Marsala, TP, 91025

  • Ftgm - Stabilimento Di Massa - Uoc Cardiologia Diagn. E Interventistica

    Massa, MS, 54100

  • Ospedale Apuane - U.O. Cardiologia-Utic

    Massa, MS, 54100

  • Ospedale S. Giovanni Di Dio - U.O. Cardiologia E Utic

    Melfi, PZ, 85025

  • Ospedale Tiberio Evoli Riabilitazione - Cardio-Respiratoria

    Melito di Porto Salvo, RC, 89063

  • Istituto Clinico Citta' Studi - U.O. Cardiologia

    Milan, MI, 20131

  • Ospedale San Raffaele - Utic E Subintensiva

    Milan, MI, 20132

  • Ospedale San Carlo Borromeo - Cardiologia-Ucc

    Milan, MI, 20153

  • P.O. Don Tonino Bello - Uosd Cardiologia

    Molfetta, BA, 70056

  • Ospedale Civile San Polo - S.O.C. Cardiologia

    Monfalcone, GO, 34074

  • Policlinico Di Monza - Uo Cardiol. Clinica E Scompenso Cardiaco

    Monza, MB, 20900

  • Ospedale Civile Minervini - Medicina Interna

    Mormanno, CS, 87026

  • Clinica Mediterranea - U.O. Di Cardiologia

    Naples, 80122

  • Aorn Cardarelli - U.O. Cardiologia Con Utic

    Naples, 80131

  • Aorn Osp. Dei Colli- Po Vincenzo Monaldi - U.O.C. Cardiologia E Utic 'Vanvitelli'

    Naples, 80131

  • Aorn Osp. Dei Colli- Po Vincenzo Monaldi - U.O.C. Cardiologia

    Naples, 80131

  • Ospedale San Gennaro - U.O. Cardiologia E Riabilitazione Card.

    Naples, 80136

  • Ospedale Del Mare - U.O. Cardiologia Con Utic

    Naples, 80142

  • Aou Maggiore Della Carita' - Cardiologia Ii

    Novara, 28100

  • Aou Maggiore Della Carita' Scdu Clinica Cardiologica-Cardiologia I

    Novara, 28100

  • Clinica San Gaudenzio - Uoa Cardiologia

    Novara, 28100

  • Ospedale San Francesco - Cardiologia - Utic

    Nuoro, NU, 08100

  • Ospedale S. Maria Della Stella - Sc Di Cardiologia

    Orvieto, TR, 05018

  • Iob - Policlinico San Marco - U.O. Cardiologia

    Osio Sotto, BG, 24046

  • Casa Di Cura Candela - Uof Cardiologia

    Palermo, PA, 90141

  • Aor Villa Sofia-Cervello P.O. Cervello - U.O. Cardiologia - Cervello

    Palermo, PA, 90146

  • Fondazione Irccs Policlinico San Matteo - Cardiologia

    Pavia, PV, 27100

  • Ics Maugeri Spa Societa' Benefit - U.O. Di Riabilitazione Cardiologica

    Pavia, PV, 27100

  • Istituto Di Cura Citta' Di Pavia - U.O. Cardiologia Ii

    Pavia, PV, 27100

  • Ospedale Civile Dello Spirito Santo - Utic E Cardiologia Interventistica

    Pescara, PE, 65124

  • Ospedale Civile Ave Gratia Plena - U.O. Di Cardiologia E Utic

    Piedimonte Matese, CE, 81016

  • Ospedale Villamarina - Cardiologia E Utic

    Piombino, LI, 57025

  • Ospedale Dell'Alta Val D'Elsa - Uosd Cardiologia-Utic

    Poggibonsi, SI, 53036

  • Ospedale Santa Maria Degli Ungheresi - U.O. Di Cardiologia

    Polistena, RC, 89024

  • Policlinico Citta' Di Pomezia S. Anna - U.O. Cardiologia-Utic

    Pomezia, RM, 00040

  • Ospedale Di Pordenone - S.O.C. Cardiologia

    Pordenone, PN, 33170

  • Azienda Ospedaliera San Carlo - S.S.D. Cardiologia Riabilitativa

    Potenza, PZ, 85100

  • Giovanni Paolo Ii - U.O.C. Cardiologia-Utic

    Ragusa, RG, 97100

  • Ospedale Civile Santa Maria Delle Croci - U.O. Di Cardiologia

    Ravenna, RA, 48100

  • Ao Bianchi Melacrino Morelli- Po Riuniti - Divisione Di Cardiologia

    Reggio Calabria, RC, 89124

  • Arcispedale Santa Maria Nuova - S.C. Cardiologia

    Reggio Emilia, RE, 42100

  • P.O. San Camillo de Lellis - U.O.C. Cardiologia

    Rieti, RI, 02100

  • Ospedale Di Roccadaspide - Cardiologia-Utic

    Roccadaspide, SA, 84069

  • Campus Biomedico - Cardiologia

    Roma, RM, 00128

  • P.O. San Filippo Neri - Asl Roma 1 - Uoc Cardiologia E Utic

    Roma, RM, 00135

  • European Hospital - Uo. Cardiologia Interventistica

    Roma, RM, 00149

  • Ospedale San Camillo - Cardiologia 2 (Ex Cardio 3)

    Roma, RM, 00152

  • Ospedale San Camillo - Uoc Cardiologia 1

    Roma, RM, 00152

  • Ospedale Sandro Pertini - Uoc Cardiologia

    Roma, RM, 00157

  • Policlinico Umberto Primo - Cardiologia B - Cardiologia E Angiologia

    Roma, RM, 00161

  • Policlinico Umberto Primo - Malattie Cardiovascolari A

    Roma, RM, 00161

  • Aurelia Hospital - U.O.C Cardiologia

    Roma, RM, 00163

  • Ospedale Madre Giuseppina Vannini - U.O.C. Cardiologia

    Roma, RM, 00177

  • Ospedale San Pietro Fatebenefratelli - U.O Complessa Di Cardiologia

    Roma, RM, 00189

  • Ospedale Sant'Andrea Di Roma - U.O.C. Cardiologia

    Roma, RM, 00189

  • Ospedale Santo Spirito - U.O.C. Di Cardiologia

    Roma, RM, 00193

  • Ospedale Santa Maria Della Misericordia - U.O.C. Cardiologia

    Rovigo, RO, 45100

  • Istituto Clinico Humanitas - Uo Emodinamica Cardiologia Invasiva Ucc

    Rozzano, Mi, 20089

  • Aou S. Giovanni Di Dio-Ruggi D'Aragona - Uoc Cardiologia Preventiva

    Salerno, SA, 84131

  • Ospedale Madonna Del Soccorso - Uoc Cardiologia Indirizzo Riabilitativo

    San Benedetto del Tronto, AP, 63074

  • Ospedale G. Fracastoro - U.O.C. Di Cardiologia

    San Bonifacio, VR, 37047

  • Irccs Policlinico San Donato - U.O. Cardiologia Con Utic

    San Donato Milanese, MI, 20097

  • Ospedale Casa Sollievo Della Sofferenza - Cardiologia - Utic - Riabil Cardiologica

    San Giovanni Rotondo, FG, 71013

  • Casa Di Salute Santa Lucia - U.O. Cardiologia

    San Giuseppe Vesuviano, 80047

  • Ospedale Di S. Vito Al Tagliamento - S.O.C. Cardiologia

    San Vito al Tagliamento, PN, 33078

  • Presidio Ospedaliero - U.O. Cardiologia

    Sanremo, IM, 18038

  • P.O. Sant'Agata Di Militello - Uoc Cardiologia

    Sant'Agata di Militello, ME, 98076

  • Ospedale San Giuseppe E Melorio - U.O.C. Cardiologia Utic

    Santa Maria Capua Vetere, CE, 81055

  • Presidio Ospedaliero Di Saronno - U.O.C. Di Cardiologia

    Saronno, VA, 21047

  • Ospedale San Bartolomeo - U.O. Cardiologia Clinica-Riabilitativa

    Sarzana, SP, 19038

  • Ospedale Di Sassuolo - Cardiologia

    Sassuolo, MO, 41049

  • Ospedale Ignazio Veris Delli Ponti - Uoc Cardiologia-Utic

    Scorrano, LE, 73020

  • Ospedale Principe Di Piemonte - Uoc Cardiologia Utic

    Senigallia, AN, 60019

  • Presidio Ospedaliero San Rocco - U.O.C. Cardiologia - Utic

    Sessa Aurunca, CE, 81037

  • Irccs Policlinico Multimedica - Uo Di Cardiologia

    Sesto San Giovanni, MI, 20099

  • Aou Senese Ospedale S. Maria Alle Scotte - U.O.C. Cardiologia Ospedaliera

    Siena, SI, 53100

  • Ospedale Di Circolo A. Bellini - Medicina Generale E Card. Riabilitativa

    Somma Lombardo, VA, 21019

  • Ospedale Umberto I - Uoc Cardiologia E Utic

    Syracuse, SR, 96100

  • Casa Di Cura Villa Verde - Cardiologia

    Taranto, TA, 74100

  • Ospedale Civile G. Mazzini -Cardiologia Utic Ed Emodinamica

    Teramo, TE, 64100

  • Centro Polifunzionale Boldrini - Cardiologia Riabilitativa-Cardioaction

    Thiene, VI, 36016

  • Ospedale San Giovanni Evangelista - U.O.C. Di Cardiologia - Utic

    Tivoli, RM, 00019

  • Maria Pia Hospital - U.O. Cardiologia

    Torino, TO, 10132

  • Ospedale Di Circolo Galmarini - Cardiologia

    Tradate, VA, 21049

  • Ospedale Santa Chiara - Divisione Di Cardiologia

    Trento, TN, 38122

  • Azienda Osp. Cardinale G. Panico - U.O. Cardiologia - Utic

    Tricase, LE, 73039

  • Ospedali Riuniti - Osp. Maggiore - A.F. Cardiologia E Riabil. Cardiologica

    Trieste, TS, 34125

  • I.R.C.C.S. Oasi Maria Ss. - U.O. Cardiologia

    Troina, EN, 94018

  • Pou Santa Maria Della Misericordia - S.O.C. Cardiologia

    Udine, UD, 33100

  • Ospedale San Luca - U.O. Utic - Cardiologia

    Vallo della Lucania, SA, 84078

  • Ospedale Di Circolo E Fondazione Macchi - Cardiologia I

    Varese, VA, 21100

  • Ospedale Civile Di Venezia - U.O. Di Cardiologia

    Venezia, VE, 30122

  • Ospedale Sant'Andrea - Sc Cardiologia

    Vercelli, VC, 13100

  • Ics Maugeri Spa Societa' Benefit - Uo Cardiologia Riabilitativa

    Veruno, 28010

  • Ospedale Civile - Cardiologia

    Vigevano, PV, 27029

  • Ospedale Belcolle - U.O.C. Cardiologia Utic Emodinamica

    Viterbo, VT, 01100

  • Ospedale Riccardo Guzzardi - U.O.C. Di Cardiologia-Utic

    Vittoria, RG, 97019

  • Ospedale Di Vizzolo Predabissi - Uo Cardiologia E Ucc

    Vizzolo Predabissi, MI, 20077

Other trials in Italy

About this study

Observational, prospective multicentric, national study, evaluating the diagnostic and therapeutic pathways of patient with cronic coronary artery disease followed in Italian cardiology centers.

Read the detailed description

Coronary heart disease is still highly prevalent in the world, and chronic stable angina is one of the most common clinical presentations of this disease. The objectives of chronic stable angina treatment include the reduction of symptoms, the inhibition or slowing of the progression of the disease, the prevention of associated cardiovascular events such as myocardial infarction, and the possible improvement of survival.The results of COURAGE Study and of meta-analysis of more recent studies demonstrate that patients in optimized medical therapy (OMT) (aspirin, beta-blocker and statin in association with an ACE-inhibitor and strict control of risk factors). ) the percutaneous coronary revascularization procedure (PCI) did not lead to an improvement in the cardiovascular prognosis. These data led the groups in charge of drafting the guidelines to recommend OMT as an initial treatment of stable angina, reserving the revascularization procedure for those patients with symptoms not adequately controlled by medical therapy.

It is therefore considered appropriate to plan a registry in patients with stable coronary artery disease that has the ability to describe in the heterogeneity of Italian cardiological centers the current characteristics of these patients, their treatment modalities, adherence to the current guidelines both as regards invasive therapy that the optimized medical, the use and the total cost of the resources needed to manage this pathology, the clinical course one year after entering the register.

Consecutive patients discharged (after an ordinary or day hospital admission) or managed as outpatient at Cardiology department participating in the project with a diagnosis of stable coronary artery disease will be included in the register. Enrollment will last 3 months in each center, starting with the first enrolled patient, or up to 50 patients enrolled.

Being tested
Data collection on Stable Ischemic heart disease

What participants receive

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

  • Data collection on Stable Ischemic heart diseaseOther

    No intervention only description of management and treatment

What is being measured

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

  1. Number of patients in medical therapy and that underwent revascularization

    Number of patients in medical therapy and that underwent revascularization

    Measured: Enrollment

Secondary outcomes (4)

  1. Number of patient in optimal medical therapy

    Patient treated according to International Guidelines

    Measured: 12 months Follow-up

  2. Mortality rate

    Rate of patients died

    Measured: 12 months Follow-up

  3. All cause hospitalization rate

    Rate of patients hospitalized

    Measured: 12 months Follow-up

  4. Angina recurrence rate

    Rate of patients with angina symtoms

    Measured: 12 months Follow-up

Timeline

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

  1. First posted8 Jan 2019
  2. Study start17 Mar 2016
  3. Primary completion28 Feb 2018
  4. Study completion24 Apr 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
5,070 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03796741
Sponsor's protocol ID
K14
Acronym
START
Status last verified
Dec 2018
First submitted
20 Dec 2018
Last updated
3 Feb 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • De Luca L, Temporelli PL, Lucci D, Colivicchi F, Calabro P, Riccio C, Amico A, Mascia F, Proia E, Di Lenarda A, Gulizia MM; START Investigators. Characteristics, treatment and quality of life of stable coronary artery disease patients with or without angina: Insights from the START study. PLoS One. 2018 Jul 12;13(7):e0199770. doi: 10.1371/journal.pone.0199770. eCollection 2018.

    PubMed 30001355

  • De Luca L, Arca M, Temporelli PL, Colivicchi F, Gonzini L, Lucci D, Bosco B, Callerame M, Lettica GV, Di Lenarda A, Gulizia MM; START Investigators. Prevalence and pharmacologic management of familial hypercholesterolemia in an unselected contemporary cohort of patients with stable coronary artery disease. Clin Cardiol. 2018 Aug;41(8):1075-1083. doi: 10.1002/clc.23031. Epub 2018 Aug 20.

    PubMed 30039543

  • Colivicchi F, Massimo Gulizia M, Arca M, Luigi Temporelli P, Gonzini L, Venturelli V, Morici N, Indolfi C, Gabrielli D, De Luca L. Lipid Lowering Treatment and Eligibility for PCSK9 Inhibition in Post-Myocardial Infarction Patients in Italy: Insights from Two Contemporary Nationwide Registries. Cardiovasc Ther. 2020 Jan 3;2020:3856242. doi: 10.1155/2020/3856242. eCollection 2020.

    PubMed 31969932

  • De Luca L, Arca M, Temporelli PL, Meessen J, Riccio C, Bonomo P, Colavita AR, Gabrielli D, Gulizia MM, Colivicchi F; START Investigators. Current lipid lowering treatment and attainment of LDL targets recommended by ESC/EAS guidelines in very high-risk patients with established atherosclerotic cardiovascular disease: Insights from the START registry. Int J Cardiol. 2020 Oct 1;316:229-235. doi: 10.1016/j.ijcard.2020.05.055. Epub 2020 May 26.

    PubMed 32470532

  • De Luca L, Formigli D, Meessen J, Uguccioni M, Cosentino N, Paolillo C, Di Lenarda A, Colivicchi F, Gabrielli D, Gulizia MM, Scherillo M; START Investigators. COMPASS criteria applied to a contemporary cohort of unselected patients with stable coronary artery diseases: insights from the START registry. Eur Heart J Qual Care Clin Outcomes. 2021 Sep 16;7(5):513-520. doi: 10.1093/ehjqcco/qcaa054.

    PubMed 32559279

  • De Luca L, Uguccioni M, Meessen J, Temporelli PL, Tomai F, De Rosa FM, Passamonti E, Formigli D, Riccio C, Gabrielli D, Colivicchi F, Gulizia MM, Perna GP. External applicability of the ISCHEMIA trial: an analysis of a prospective, nationwide registry of patients with stable coronary artery disease. EuroIntervention. 2020 Dec 18;16(12):e966-e973. doi: 10.4244/EIJ-D-20-00610.

    PubMed 32830646

  • De Luca L, Temporelli PL, Amico AF, Gonzini L, Uguccioni M, Varani E, Brunetti ND, Colivicchi F, Gabrielli D, Gulizia MM. Impact of history of depression on 1-year outcomes in patients with chronic coronary syndromes: An analysis of a contemporary, prospective, nationwide registry. Int J Cardiol. 2021 May 15;331:273-280. doi: 10.1016/j.ijcard.2020.12.086. Epub 2021 Jan 8.

    PubMed 33422564

  • De Luca L, Temporelli PL, Lucci D, Gonzini L, Riccio C, Colivicchi F, Geraci G, Formigli D, Maras P, Falcone C, Di Lenarda A, Gulizia MM; START Investigators. Current management and treatment of patients with stable coronary artery diseases presenting to cardiologists in different clinical contexts: A prospective, observational, nationwide study. Eur J Prev Cardiol. 2018 Jan;25(1):43-53. doi: 10.1177/2047487317740663. Epub 2017 Nov 10.

    PubMed 29124952

  • De Luca L, Temporelli PL, Riccio C, Gonzini L, Marinacci L, Tartaglione SN, Costa P, Scherillo M, Senni M, Colivicchi F, Gulizia MM; START Investigators. Clinical outcomes, pharmacological treatment, and quality of life of patients with stable coronary artery diseases managed by cardiologists: 1-year results of the START study. Eur Heart J Qual Care Clin Outcomes. 2019 Oct 1;5(4):334-342. doi: 10.1093/ehjqcco/qcz002.

    PubMed 30649303

Questions about this trial

What is this clinical trial studying?

An observational study of Chronic Ischemic Heart Disease, run by Heart Care Foundation at 183 sites in Italy.

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 3 inclusion and 3 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 3 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 183 sites in Italy. 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?

Number of patients in medical therapy and that underwent revascularization (time frame: Enrollment). 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 NCT03796741, which also lists 9 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 3 Feb 2021.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in