Acute and Long-term Outcomes of Patients With Acute Myocardial Infarction Treated With PCI (SINERGY-ACUTE)

March 12, 2022 updated by: Goran Stankovic, Clinical Centre of Serbia

Acute and Long-term Outcomes of Patients Presenting With Acute Myocardial Infarction Treated With Primary Percutaneous Coronary Intervention

Randomized studies may often be burdened by the selective nature of patient inclusion thus not reflecting real-world outcomes. This is evident from the discrepancy in the mortality rates reported in major randomized trials enrolling patients with acute myocardial infarction (AMI), as compared with registry data.

The primary objective of this observational study is to assess short- and long-term outcomes of unselected, real-world patients presenting with AMI and treated with contemporary percutaneous coronary intervention (PCI).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

30000

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 Locations

  • Serbia
      • Belgrade, Serbia, 11000
        • Recruiting
        • Clinical Centre of Serbia, Department of Cardiology
        • Contact:
          • Goran Stankovic, MD, PhD

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

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

This registry is based on consecutive patients with the initial diagnosis of acute myocardial infarction on admission to hospital, who are referred to invasive treatment, i.e. invasive coronary angiography with an intention to perform percutaneous coronary intervention. The study population will include both retrospective, multi-center registry data starting with the year 2009, and the prospectively enrolled patients according to the same pre-specified, broad inclusion/exclusion criteria. The underlying intention is to short- and long-term outcomes of a large population of unselected, real-world patients presenting with AMI and treated with PCI.

Description

Inclusion Criteria:

  • Patients with acute myocardial infarction referred to catheterization laboratory for percutaneous coronary intervention

Exclusion Criteria:

  • Initial acute myocardial infarction diagnosis not confirmed
  • Patients with acute myocardial infarction not undergoing invasive coronary angiography

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

  • Observational Models: Cohort
  • Time Perspectives: Other

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Acute Myocardial Infarction
Consecutive patients with acute myocardial infarction
Procedure: Percutaneous Coronary Intervention
Percutaneous Coronary Intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of all-cause mortality
Time Frame: 1 year
Rate of all-cause mortality at 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of all-cause mortality
Time Frame: 5 years
Rate of all-cause mortality at 5 years
5 years
Rate of cardiovascular mortality
Time Frame: 5 years
Rate of cardiovascular mortality at 5 years
5 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of myocardial infarction
Time Frame: 5 years
Rate of myocardial infarction at 5 years
5 years
Rate of repeat revascularization
Time Frame: 5 years
Rate of repeat revascularization at 5 years
5 years
Rate of stroke
Time Frame: 5 years
Rate of stroke at 5 years
5 years
Rate of new or worsening heart failure
Time Frame: 5 years
Rate of new or worsening heart failure at 5 years
5 years
Rate of new or worsening heart failure
Time Frame: 1 year
Rate of new or worsening heart failure at 1 year
1 year

Collaborators and Investigators

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

Sponsor

Clinical Centre of Serbia

Collaborators

Institute of Cardiovascular Diseases Vojvodina
Clinical Hopital Center Zemun
University Hospital Medical Center Bezanijska Kosa
Clinical Centre of Kragujevac
Clinical Hospital Center Zvezdara

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)

January 1, 2009

Primary Completion (Anticipated)

January 1, 2024

Study Completion (Anticipated)

January 1, 2025

Study Registration Dates

First Submitted

August 6, 2020

First Submitted That Met QC Criteria

August 6, 2020

First Posted (Actual)

August 10, 2020

Study Record Updates

Last Update Posted (Actual)

March 29, 2022

Last Update Submitted That Met QC Criteria

March 12, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 570/11

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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