International Survey of Acute Coronary Syndromes

NCT ID: NCT01218776

Last Updated: 2025-04-16

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 36000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-09-28
• Study Completion Date: 2026-12-31

Brief Summary

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).

Conditions

Acute Coronary Syndrome; Unstable Angina Pectoris; Myocardial Infarction; Coronary Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Male, Female, Kidney Disease, Elderly

Non-interventional patient registry

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• acute coronary syndromes

Exclusion Criteria

• under age or not able to give informed consent

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Bologna

OTHER

Sponsor Role: lead

Responsible Party

Raffaele Bugiardini

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Raffaele Bugiardini, MD

Role: PRINCIPAL_INVESTIGATOR

University of Bologna

Locations

University of Bologna

Bologna, Emilia-Romagna, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Raffaele Bugiardini, MD

Role: CONTACT

raffaele.bugiardini@unibo.it

+39 335 5612962

Lina Badimon, MD

Role: CONTACT

badimon@csic-iccc.org

+34 670296741

Facility Contacts

Raffaele Bugiardini, MD

Role: primary

raffaele.bugiardini@unibo.it

+39 335 5612962

Lina Badimon, MD

Role: backup

lbadimon@csic-iccc.org

+34 670296741

References

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

Reference Type: BACKGROUND

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 2015 Apr 27.

Reference Type: RESULT

PMID: 25988359 (View on PubMed)

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.

Reference Type: RESULT

PMID: 26778165 (View on PubMed)

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: http://dx.doi.org/10.1093/eurheartj/sut019. First published online: 10 January 2014

Reference Type: RESULT

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.

Reference Type: RESULT

PMID: 29474588 (View on PubMed)

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

Reference Type: RESULT

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 online: 10 January 2014

Reference Type: RESULT

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: http://dx.doi.org/10.1093/eurheartj/sut015 First published online: 10 January 2014

Reference Type: RESULT

Manfrini O, Ricci B, Cenko E, Dorobantu M, Kalpak O, Kedev S, Knezevic B, Koller A, Milicic D, Vasiljevic Z, Badimon L, Bugiardini R; ISACS-TC Investigators. Association between comorbidities and absence of chest pain in acute coronary syndrome with in-hospital outcome. Int J Cardiol. 2016 Aug;217 Suppl:S37-43. doi: 10.1016/j.ijcard.2016.06.221. Epub 2016 Jun 28.

Reference Type: RESULT

PMID: 27381858 (View on PubMed)

Calmac L, Bataila V, Ricci B, Vasiljevic Z, Kedev S, Gustiene O, Trininic D, Knezevic B, Milicic D, Dilic M, Manfrini O, Cenko E, Badimon L, Bugiardini R, Scafa-Udriste A, Tautu O, Dorobantu M. Factors associated with use of percutaneous coronary intervention among elderly patients presenting with ST segment elevation acute myocardial infarction (STEMI): Results from the ISACS-TC registry. Int J Cardiol. 2016 Aug;217 Suppl:S21-6. doi: 10.1016/j.ijcard.2016.06.227. Epub 2016 Jun 29.

Reference Type: RESULT

PMID: 27381859 (View on PubMed)

Bugiardini R, Badimon L; ISACS-TC Investigators and Coordinators. The International Survey of Acute Coronary Syndromes in Transitional Countries (ISACS-TC): 2010-2015. Int J Cardiol. 2016 Aug;217 Suppl:S1-6. doi: 10.1016/j.ijcard.2016.06.219. Epub 2016 Jun 28.

Reference Type: RESULT

PMID: 27386758 (View on PubMed)

Cenko E, Ricci B, Kedev S, Kalpak O, Calmac L, Vasiljevic Z, Knezevic B, Dilic M, Milicic D, Manfrini O, Koller A, Dorobantu M, Badimon L, Bugiardini R. The no-reflow phenomenon in the young and in the elderly. Int J Cardiol. 2016 Nov 1;222:1122-1128. doi: 10.1016/j.ijcard.2016.07.209. Epub 2016 Aug 2.

Reference Type: RESULT

PMID: 27499222 (View on PubMed)

Ricci B, Manfrini O, Cenko E, Vasiljevic Z, Dorobantu M, Kedev S, Davidovic G, Zdravkovic M, Gustiene O, Knezevic B, Milicic D, Badimon L, Bugiardini R. Primary percutaneous coronary intervention in octogenarians. Int J Cardiol. 2016 Nov 1;222:1129-1135. doi: 10.1016/j.ijcard.2016.07.204. Epub 2016 Aug 2.

Reference Type: RESULT

PMID: 27506888 (View on PubMed)

Cenko E, Ricci B, Kedev S, Vasiljevic Z, Dorobantu M, Gustiene O, Knezevic B, Milicic D, Dilic M, Manfrini O, Koller A, Badimon L, Bugiardini R. Invasive versus conservative strategy in acute coronary syndromes: The paradox in women's outcomes. Int J Cardiol. 2016 Nov 1;222:1110-1115. doi: 10.1016/j.ijcard.2016.07.211. Epub 2016 Jul 30.

Reference Type: RESULT

PMID: 27514628 (View on PubMed)

Bugiardini R, Ricci B, Cenko E, Vasiljevic Z, Kedev S, Davidovic G, Zdravkovic M, Milicic D, Dilic M, Manfrini O, Koller A, Badimon L. Delayed Care and Mortality Among Women and Men With Myocardial Infarction. J Am Heart Assoc. 2017 Aug 21;6(8):e005968. doi: 10.1161/JAHA.117.005968.

Reference Type: RESULT

PMID: 28862963 (View on PubMed)

Ricci B, Cenko E, Vasiljevic Z, Stankovic G, Kedev S, Kalpak O, Vavlukis M, Zdravkovic M, Hinic S, Milicic D, Manfrini O, Badimon L, Bugiardini R. Acute Coronary Syndrome: The Risk to Young Women. J Am Heart Assoc. 2017 Dec 22;6(12):e007519. doi: 10.1161/JAHA.117.007519.

Reference Type: RESULT

PMID: 29273636 (View on PubMed)

Cenko E, Yoon J, Kedev S, Stankovic G, Vasiljevic Z, Krljanac G, Kalpak O, Ricci B, Milicic D, Manfrini O, van der Schaar M, Badimon L, Bugiardini R. Sex Differences in Outcomes After STEMI: Effect Modification by Treatment Strategy and Age. JAMA Intern Med. 2018 May 1;178(5):632-639. doi: 10.1001/jamainternmed.2018.0514.

Reference Type: RESULT

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Cenko E, van der Schaar M, Yoon J, Kedev S, Valvukis M, Vasiljevic Z, Asanin M, Milicic D, Manfrini O, Badimon L, Bugiardini R. Sex-Specific Treatment Effects After Primary Percutaneous Intervention: A Study on Coronary Blood Flow and Delay to Hospital Presentation. J Am Heart Assoc. 2019 Feb 19;8(4):e011190. doi: 10.1161/JAHA.118.011190.

Reference Type: RESULT

PMID: 30764687 (View on PubMed)

Cenko E, van der Schaar M, Yoon J, Manfrini O, Vasiljevic Z, Vavlukis M, Kedev S, Milicic D, Badimon L, Bugiardini R. Sex-Related Differences in Heart Failure After ST-Segment Elevation Myocardial Infarction. J Am Coll Cardiol. 2019 Nov 12;74(19):2379-2389. doi: 10.1016/j.jacc.2019.08.1047.

Reference Type: RESULT

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Bugiardini R, Yoon J, Kedev S, Stankovic G, Vasiljevic Z, Milicic D, Manfrini O, van der Schaar M, Gale CP, Badimon L, Cenko E. Prior Beta-Blocker Therapy for Hypertension and Sex-Based Differences in Heart Failure Among Patients With Incident Coronary Heart Disease. Hypertension. 2020 Sep;76(3):819-826. doi: 10.1161/HYPERTENSIONAHA.120.15323. Epub 2020 Jul 13.

Reference Type: RESULT

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Bugiardini R, Yoon J, Mendieta G, Kedev S, Zdravkovic M, Vasiljevic Z, Milicic D, Manfrini O, van der Schaar M, Gale CP, Bergami M, Badimon L, Cenko E. Reduced Heart Failure and Mortality in Patients Receiving Statin Therapy Before Initial Acute Coronary Syndrome. J Am Coll Cardiol. 2022 May 24;79(20):2021-2033. doi: 10.1016/j.jacc.2022.03.354.

Reference Type: RESULT

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Bergami M, Cenko E, Yoon J, Mendieta G, Kedev S, Zdravkovic M, Vasiljevic Z, Milicic D, Manfrini O, van der Schaar M, Gale CP, Badimon L, Bugiardini R. Statins for primary prevention among elderly men and women. Cardiovasc Res. 2022 Nov 10;118(14):3000-3009. doi: 10.1093/cvr/cvab348.

Reference Type: RESULT

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Bugiardini R, Cenko E, Yoon J, van der Schaar M, Kedev S, Gale CP, Vasiljevic Z, Bergami M, Milicic D, Zdravkovic M, Krljanac G, Badimon L, Manfrini O. Concerns about the use of digoxin in acute coronary syndromes. Eur Heart J Cardiovasc Pharmacother. 2022 Aug 11;8(5):474-482. doi: 10.1093/ehjcvp/pvab055.

Reference Type: RESULT

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Bugiardini R, Pavasovic S, Yoon J, van der Schaar M, Kedev S, Vavlukis M, Vasiljevic Z, Bergami M, Milicic D, Manfrini O, Cenko E, Badimon L. Aspirin for primary prevention of ST segment elevation myocardial infarction in persons with diabetes and multiple risk factors. EClinicalMedicine. 2020 Sep 20;27:100548. doi: 10.1016/j.eclinm.2020.100548. eCollection 2020 Oct.

Reference Type: RESULT

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Manfrini O, Yoon J, van der Schaar M, Kedev S, Vavlukis M, Stankovic G, Scarpone M, Milicic D, Vasiljevic Z, Badimon L, Cenko E, Bugiardini R. Sex Differences in Modifiable Risk Factors and Severity of Coronary Artery Disease. J Am Heart Assoc. 2020 Oct 20;9(19):e017235. doi: 10.1161/JAHA.120.017235. Epub 2020 Sep 28.

Reference Type: RESULT

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Cenko E, Bergami M, Yoon J, Vadala G, Kedev S, Kostov J, Vavlukis M, Vraynko E, Milicic D, Vasiljevic Z, Zdravkovic M, Galassi AR, Manfrini O, Bugiardini R. Age and sex differences in the efficacy of early invasive strategy for non-ST-elevation acute coronary syndrome: A comparative analysis in stable patients. Am J Prev Cardiol. 2025 Mar 29;22:100984. doi: 10.1016/j.ajpc.2025.100984. eCollection 2025 Jun.

Reference Type: DERIVED

PMID: 40256411 (View on PubMed)

Fabin N, Cenko E, Bergami M, Yoon J, Vadala G, Mendieta G, Kedev S, Kostov J, Vavlukis M, Vraynko E, Milicic D, Vasiljevic Z, Zdravkovic M, Badimon L, Galassi AR, Manfrini O, Bugiardini R. Early coronary revascularization among 'stable' patients with non-ST-segment elevation acute coronary syndromes: the role of diabetes and age. Cardiovasc Res. 2024 Dec 14;120(16):2064-2077. doi: 10.1093/cvr/cvae190.

Reference Type: DERIVED

PMID: 39196713 (View on PubMed)

Vasiljevic-Pokrajcic Z, Mickovski N, Davidovic G, Asanin M, Stefanovic B, Krljanac G, Radosavljevic-Radovanovic M, Radovanovic N, Lasica R, Milanovic S, Bjekic J, Majstorovic-Stakic M, Trifunovic D, Karadzic A, Rajic D, Milosevic A, Zdravkovic M, Saric J, Bugiardini R. Sex and age differences and outcomes in acute coronary syndromes. Int J Cardiol. 2016 Aug;217 Suppl:S27-31. doi: 10.1016/j.ijcard.2016.06.217. Epub 2016 Jun 27.

Reference Type: DERIVED

PMID: 27395070 (View on PubMed)

Other Identifiers

ISACS-TC 1

Identifier Type: -

Identifier Source: org_study_id