International Survey of Acute Coronary Syndromes in Transitional Countries

Myocardial Infarction Clinical Trial

— ISACS-TC  

Official title:

International Survey of Acute Coronary Syndromes in Transitional Countries

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01218776
• Other study ID #: ISACS-TC 1
• Status: Recruiting
• Start date: September 28, 2010
• Est. completion date: December 31, 2026

Study information

• Verified date: October 2023
• Source: University of Bologna
• Contact: Raffaele Bugiardini, MD
• Phone: +39 335 5612962
• Email: raffaele.bugiardini[@]unibo.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The International Registry of Acute Coronary Syndromes registry study in Transitional Countries (ISACS-TC) 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 Further study details as provided by the CINECA http://isacs-ct.cineca.org/

Description:

Aims of this survey study are (1) documentation of the characteristics of all patients presenting to the ISACS-TC 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.

Further study details as provided by the CINECA http://isacs-ct.cineca.org/

Investigators:

ISACS-TC Administrative Committee:

Raffaele Bugiardini (Italy-Principal Investigator) Lina Badimon (Spain) Viola Vaccarino (United States-Project Director) Olivia Manfrini (Italy- Project Coordinator) Edina Cenko (Italy-Center Coordinator)

Steering Committee:

Aleksandar Lazarevic, Mirza Dilic and Dijana Trninic(Bosnia and Herzegovina), Asen Goudev (Bulgaria), Davor Milicic (Croatia), Kalman Toth (Hungary), 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 (FYR Macedonia), Mihail Popovici (Moldova), Bozidarka Knezevic and Nebojsa Bulatovic (Montenegro), Maria Dorobantu (Romania), Zorana Vasiljevic and Goran Stankovic (Serbia), Eva Goncalvesova and Martin Studenkan (Slovakia) , Alexander N. Parkhomenko (Ukraine) , Alistair Hall and Christopher P Gale (United Kingdom).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36000
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• acute coronary syndromes

Exclusion Criteria:

• under age or not able to give informed consent

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Angina Pectoris
• Angina, Unstable
• Coronary Disease
• Infarction
• Myocardial Infarction
• Syndrome
• Unstable Angina Pectoris

Locations

Country	Name	City	State
Italy	University of Bologna	Bologna	Emilia Romagna

Sponsors (1)

Lead Sponsor	Collaborator
University of Bologna

Country where clinical trial is conducted

Italy, 

References & Publications (25)

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):3000-30 — View 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

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 Ju — View 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 Coro — View 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. 202 — View 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 — View 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 multipl — View 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. d — View 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 He — View 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 — View 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 interven — View 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 — View 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 Card — View 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 reg — View 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 Pr — View 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):2379-238 — View 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 M — View 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

Manfrini O, Dorobantu M, Vasiljevic Z, Kedev S, Kneževic B, Milicic D, Dilic M, Trninic D, Daullxhiu I, Gustiene O, Ricci B, Martelli I, Cenko E, Koller A, Badimon L, Bugiardini R. Acute coronary syndrome in octogenarian patients: results from the interna

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-ho — View 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 2 — View 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/ — View 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. — View Citation

Trninic D, Dilic M, Vasiljevic Z, Kulic M, Srdic S, Dobrijevic 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. C

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 my

* Note: There are 25 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All causes mortality	All causes mortality	30 days, 6 months, 1 year
Secondary	Cardiovascular mortality	Cardiovascular mortality	30 days, 6 months, 1 year
Secondary	Recurrent myocardial infarction	Recurrent myocardial infarction	30 days, 6 months, 1year
Secondary	Pharmacogenetic and cardiovascular genetic studies associated to clinical outcomes	Pharmacogenetic and cardiovascular genetic studies associated to clinical outcomes	6 month, 1 year
Secondary	Adherence to internationally guideline recommended therapies across the participating countries	Adherence to internationally guideline recommended therapies across the participating	discharge, 6 months, 1 year

External Links

•   CINECA