NCT04506047

Brief Summary

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2009

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
11.6 years until next milestone

First Submitted

Initial submission to the registry

August 6, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 10, 2020

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2025

Completed
Last Updated

March 29, 2022

Status Verified

March 1, 2022

Enrollment Period

15 years

First QC Date

August 6, 2020

Last Update Submit

March 12, 2022

Conditions

Acute Myocardial InfarctionCoronary Artery Disease

Keywords

AMI

Outcome Measures

Primary Outcomes (1)

  • Rate of all-cause mortality

    Rate of all-cause mortality at 1 year

    1 year

Secondary Outcomes (2)

  • Rate of all-cause mortality

    5 years

  • Rate of cardiovascular mortality

    5 years

Other Outcomes (5)

  • Rate of myocardial infarction

    5 years

  • Rate of repeat revascularization

    5 years

  • Rate of stroke

    5 years

  • +2 more other outcomes

Study Arms (1)

Acute Myocardial Infarction

Consecutive patients with acute myocardial infarction

Procedure: Percutaneous Coronary Intervention

Interventions

Percutaneous Coronary InterventionPROCEDURE

Percutaneous Coronary Intervention

Acute Myocardial Infarction

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Centre of Serbia, Department of Cardiology

Belgrade, 11000, Serbia

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Percutaneous Coronary Intervention

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

Endovascular ProceduresVascular Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical Procedures

Central Study Contacts

Goran Stankovic, MD, PhD

CONTACT

+381113613653gorastan@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 6, 2020

First Posted

August 10, 2020

Study Start

January 1, 2009

Primary Completion

January 1, 2024

Study Completion

January 1, 2025

Last Updated

March 29, 2022

Record last verified: 2022-03

Locations

SE(1)