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

October 11, 2023 updated by: Raffaele Bugiardini, University of Bologna
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/

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

36000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
    • Emilia Romagna
      • Bologna, Emilia Romagna, Italy, 40138
        • Recruiting
        • University of Bologna
        • Contact:
        • Contact:
        • Principal Investigator:
          • Raffaele Bugiardini, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Subjects admitted with a diagnosis of acute coronary syndromes.

Description

Inclusion Criteria:

  • acute coronary syndromes

Exclusion Criteria:

  • under age or not able to give informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Male, Female, Kidney Disease, Elderly
Non-interventional patient registry

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All causes mortality
Time Frame: 30 days, 6 months, 1 year
All causes mortality
30 days, 6 months, 1 year

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Bologna

Investigators

  • Principal Investigator: Raffaele Bugiardini, MD, University of Bologna

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 28, 2010

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

October 7, 2010

First Submitted That Met QC Criteria

October 8, 2010

First Posted (Estimated)

October 11, 2010

Study Record Updates

Last Update Posted (Actual)

October 12, 2023

Last Update Submitted That Met QC Criteria

October 11, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ISACS-TC 1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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