Clinical trial NCT01218776: International Survey of Acute Coronary Syndromes
Official title: International Survey of Acute Coronary Syndromes
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Acute Coronary Syndrome
Unstable Angina Pectoris
Myocardial Infarction
Coronary Disease
Keywords: Acute Coronary Syndrome, Eastern Europe, Therapies
Lead sponsor: University of Bologna
Sponsor class: OTHER
First posted: 2010-10-11
Enrollment: 36000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects admitted with a diagnosis of acute coronary syndromes.

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).

Eligibility criteria: Inclusion Criteria:

* acute coronary syndromes

Exclusion Criteria:

* under age or not able to give informed consent

Primary outcomes:
measure: All causes mortality
timeFrame: 30 days, 6 months, 1 year
Secondary outcomes:
measure: Cardiovascular mortality
timeFrame: 30 days, 6 months, 1 year
measure: Recurrent myocardial infarction
timeFrame: 30 days, 6 months, 1year
measure: Pharmacogenetic and cardiovascular genetic studies associated to clinical outcomes
timeFrame: 6 month, 1 year
measure: Adherence to internationally guideline recommended therapies across the participating countries
timeFrame: discharge, 6 months, 1 year
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: University of Bologna
state: Emilia Romagna
Study officials:
affiliation: University of Bologna
name: Raffaele Bugiardini, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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
citation: 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.
citation: 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.
citation: 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
citation: 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.
citation: 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
citation: 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
citation: 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
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.