International Survey of Acute Coronary Syndromes

NCT01218776 | Recruiting

• 1 other identifier: ISACS-TC 1
• Study Type: observational
• Target: 36,000
• Locations: 1 country
• Sites: 1

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

Conditions

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

Keywords

Acute Coronary Syndrome, Eastern Europe, Therapies

Outcome Measures

Primary Outcomes (1)

• All causes mortality

  All causes mortality

  30 days, 6 months, 1 year

Secondary Outcomes (4)

• Cardiovascular mortality

  30 days, 6 months, 1 year

• Recurrent myocardial infarction

  30 days, 6 months, 1year

• Pharmacogenetic and cardiovascular genetic studies associated to clinical outcomes

  6 month, 1 year

• Adherence to internationally guideline recommended therapies across the participating countries

  discharge, 6 months, 1 year

Study Arms (1)

Male, Female, Kidney Disease, Elderly

Non-interventional patient registry

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Subjects admitted with a diagnosis of acute coronary syndromes.

You may qualify if:

• acute coronary syndromes

You may not qualify if:

• under age or not able to give informed consent

Sponsors & Collaborators

• University of Bologna: lead

Study Sites (1)

University of Bologna

Bologna, Emilia-Romagna, 40138, Italy

RECRUITING

Related Publications (28)

• 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

  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.

  PMID: 25988359 RESULT

• 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 RESULT

• 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

  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.

  PMID: 29474588 RESULT

• 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

  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

  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

  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.

  PMID: 27381858 RESULT

• 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.

  PMID: 27381859 RESULT

• 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.

  PMID: 27386758 RESULT

• 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.

  PMID: 27499222 RESULT

• 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.

  PMID: 27506888 RESULT

• 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.

  PMID: 27514628 RESULT

• 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.

  PMID: 28862963 RESULT

• 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.

  PMID: 29273636 RESULT

• 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.

  PMID: 29630703 RESULT

• 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.

  PMID: 30764687 RESULT

• 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.

  PMID: 31699278 RESULT

• 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.

  PMID: 32654558 RESULT

• 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.

  PMID: 35589164 RESULT

• 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.

  PMID: 34864917 RESULT

• 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.

  PMID: 34251454 RESULT

• 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.

  PMID: 33150322 RESULT

• 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.

  PMID: 32981423 RESULT

• 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.

  PMID: 40256411 DERIVED

• 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.

  PMID: 39196713 DERIVED

• 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.

  PMID: 27395070 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

whole blood, serum, white cells,

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Angina Pectoris; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Infarction; Ischemia; Pathologic Processes; Necrosis

Study Officials

• Raffaele Bugiardini, MD

  University of Bologna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Raffaele Bugiardini, MD

CONTACT

+39 335 5612962; raffaele.bugiardini@unibo.it

Lina Badimon, MD

CONTACT

+34 670296741; badimon@csic-iccc.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 7, 2010
• First Posted: October 11, 2010
• Study Start: September 28, 2010
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 16, 2025

Record last verified: 2025-04

Locations

IT (1)