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Recruiting NCT01218776

International Survey of Acute Coronary Syndromes

— Observational Acute Coronary Syndrome Unstable Angina Pectoris Myocardial Infarction Coronary Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Acute Coronary Syndrome, Unstable Angina Pectoris, Myocardial Infarction, Coronary Disease. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

The International Registry of Acute Coronary Syndromes registry study (ISACS) is both a retrospective and prospective study which was designed in order to obtain data of patients with acute coronary syndromes, and herewith control and optimize internationally guideline-recommended therapies in these countries

Detailed description

Aims of this survey study are (1) documentation of the characteristics of all patients presenting to the ISACS centers with STEMI or NSTEMI (2) documentation of in-hospital outcome, and outcome rates at 6 month and 1 year, (3) documentation of invasive procedures and procedure-associated complications (4) documentation of therapeutic regimens and investigation conformity of treatment with already established guidelines.

Investigators:

ISACS Administrative Committee:

Raffaele Bugiardini (Italy-Principal Investigator) Lina Badimon (Spain) Olivia Manfrini (Italy- Project Coordinator) Edina Cenko (Italy-Center Coordinator)

Steering Committee:

Mirza Dilic (Bosnia and Herzegovina), Asen Goudev (Bulgaria), Davor Milicic (Croatia), Raffaele Bugiardini, Edina Cenko and Olivia Manfrini (Italy) Gani Bajraktari (Kosovo), Andrejs Erglis and Ilja Zakke (Latvia), Remigius Zaliunas and Olivija Gustiene (Lithuania), Sasko Kedev and Marija Vavlukis (North Macedonia), Mihail Popovici (Moldova), Maria Dorobantu (Romania), Zorana Vasiljevic (Serbia), Eva Goncalvesova and Martin Studenkan (Slovakia) , Alexander N. Parkhomenko (Ukraine) , Christopher P Gale (United Kingdom).

Primary outcome measures

  • All causes mortality [Time frame: 30 days, 6 months, 1 year]
Secondary outcome measures (4)
  • Cardiovascular mortality [Time frame: 30 days, 6 months, 1 year]
  • Recurrent myocardial infarction [Time frame: 30 days, 6 months, 1year]
  • Pharmacogenetic and cardiovascular genetic studies associated to clinical outcomes [Time frame: 6 month, 1 year]
  • Adherence to internationally guideline recommended therapies across the participating countries [Time frame: discharge, 6 months, 1 year]

Eligibility criteria

Inclusion criteria

  • acute coronary syndromes

Exclusion criteria

  • under age or not able to give informed consent

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Italy · 1 center
  • University of Bologna — Bologna

Publications

  • Bugiardini R, Badimon L , Manfrini O. Rationale and design of the ISACS-TC (International Survey of Acute Coronary Syndromes in Transitional Countries) project. Eur Heart J Suppl. 2014;16 (suppl A): A1-A6 DOI: http://dx.doi.org/10.1093/eurheartj/sut002. First published online: 10 January 2014
  • Bugiardini R, Dorobantu M, Vasiljevic Z, Kedev S, Knezevic B, Milicic D, Calmac L, Trninic D, Daullxhiu I, Cenko E, Ricci B, Puddu PE, Manfrini O, Koller A, Badimon L; ISACS-TC Investigators. Unfractionated heparin-clopidogrel combination in ST-elevation myocardial infarction not receiving reperfusion therapy. Atherosclerosis. 2015 Jul;241(1):151-6. doi: 10.1016/j.atherosclerosis.2015.04.794. Epub PMID 25988359
  • Bugiardini R, Cenko E, Ricci B, Vasiljevic Z, Dorobantu M, Kedev S, Vavlukis M, Kalpak O, Puddu PE, Gustiene O, Trninic D, Knezevic B, Milicic D, Gale CP, Manfrini O, Koller A, Badimon L. Comparison of Early Versus Delayed Oral beta Blockers in Acute Coronary Syndromes and Effect on Outcomes. Am J Cardiol. 2016 Mar 1;117(5):760-7. doi: 10.1016/j.amjcard.2015.11.059. Epub 2015 Dec 13. PMID 26778165
  • Manfrini O, Dorobantu M, Vasiljevic Z, Kedev S, Knežević B, Miličić D, Dilic M, Trninic D, Daullxhiu I, Gustienė O, Ricci B, Martelli I, Cenko E, Koller A, Badimon L, Bugiardini R. Acute coronary syndrome in octogenarian patients: results from the international registry of acute coronary syndromes in transitional countries (ISACS-TC) registry. Eur Heart J Suppl.2014;16 (suppl A): A87-A94. DOI: htt
  • Cenko E, Ricci B, Kedev S, Vasiljevic Z, Dorobantu M, Gustiene O, Knezevic B, Milicic D, Dilic M, Trninic D, Smith F, Manfrini O, Badimon L, Bugiardini R. Reperfusion therapy for ST-elevation acute myocardial infarction in Eastern Europe: the ISACS-TC registry. Eur Heart J Qual Care Clin Outcomes. 2016 Jan 1;2(1):45-51. doi: 10.1093/ehjqcco/qcv025. PMID 29474588
  • Dorobantu M, Tautu O.-F, Fruntelata A, Calmac L, Tatu-Chitoiu G, Bataila V, Dimulescu D, Craiu E, Nanea T, Istvan A, Babes K, Macarie C, Militaru C, Cenko E, Manfrini O. Hypertension and acute coronary syndromes in Romania: Data from the ISACS-TC registry. Eur Heart J Suppl (2014) 16 (suppl A): A20-A27 DOI: http://dx.doi.org/10.1093/eurheartj/sut006 First published online: 10 January 2014
  • Vasiljevic Z, Krljanac G, Davidovic G, Panic G, Radovanovic S, Mickovski N, Srbljak N, Markovic-Nikolic N, Curic-Petkovic S, Panic M, Cenko E, Manfrini O, Martelli I, Koller A, Badimon L, Bugiardini R. Gender differences in case fatality rates of acute myocardial infarction in Serbia. Eur Heart J Suppl (2014) 16 (suppl A): A48-A55 DOI: http://dx.doi.org/10.1093/eurheartj/sut012 First published onl
  • Trninic D, Dilic M, Vasiljevic Z, Kulic M, Srdić S, Dobrijević N, Sabanovic-Bajramovic N, Begic A, Kukavica N, Vukcevic V, Davidovic G, Panic G, Saric J, Zrnic M, Matic I, Trifunovic N, Martelli I, Cenko E, Manfrini O, Koller A, Badimon L, Bugiardini R. Clinical profile of patients with no-reperfusion therapy in Bosnia and Herzegovina and Serbia. Eur Heart J Suppl (2014) 16 (suppl A): A67-A73 DOI:

Identifiers

NCT: NCT01218776 · ISACS-TC 1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗