ISACS-TC: International Survey of Acute Coronary Syndromes in Transitional Countries

Sponsor

University of Bologna (Other)

Overall Status

Recruiting

CT.gov ID

NCT01218776

Collaborator

(none)

24,000

Enrollment

Location

147.1

Anticipated Duration (Months)

163.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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/

Condition or Disease	Intervention/Treatment	Phase
Acute Coronary Syndrome Unstable Angina Pectoris Myocardial Infarction Coronary Disease

Detailed 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).

Study Design

Study Type:

Observational

Anticipated Enrollment :

24000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

International Survey of Acute Coronary Syndromes in Transitional Countries

Actual Study Start Date :

Sep 28, 2010

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Male, Female, Kidney Disease, Elderly Non-interventional patient registry

Outcome Measures

Primary Outcome Measures

All causes mortality [30 days, 6 months, 1 year]
All causes mortality

Secondary Outcome Measures

Cardiovascular mortality [30 days, 6 months, 1 year]
Cardiovascular mortality
Recurrent myocardial infarction [30 days, 6 months, 1year]
Recurrent myocardial infarction
Pharmacogenetic and cardiovascular genetic studies associated to clinical outcomes [6 month, 1 year]
Pharmacogenetic and cardiovascular genetic studies associated to clinical outcomes
Adherence to internationally guideline recommended therapies across the participating countries [discharge, 6 months, 1 year]
Adherence to internationally guideline recommended therapies across the participating