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Clinical Trials/NCT06048003
NCT06048003
Recruiting
Not Applicable

Armenian National Registry of ST-elevation Myocardial Infarction,a Multicenter Prospective Observational Study With Biocollection

Armenian Cardiologists Association13 sites in 1 country2,500 target enrollmentDecember 1, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
ST Elevation Myocardial Infarction
Sponsor
Armenian Cardiologists Association
Enrollment
2500
Locations
13
Primary Endpoint
Rate of the in-hospital mortality
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

This is a national, multicenter prospective observational study of patients presenting to hospitals in Armenia with STEMI diagnosis.

The main questions it aims to answer are:

  • Determine the rate of in-hospital mortality for the patients with STEMI admitted to the participating hospitals.
  • Compare short and long-term CV and all-cause mortality and hospitalization.
  • Determine how professional guidelines are followed in real-world situations.

Detailed Description

Although the state program on primary percutaneous coronary intervention in ST elevated myocardial infarction, which was launched in 2015 helped to drastically decrease STEMI mortality rates, patients who had survived usually develop heart failure (HF) which leads to increased economic burden for the Armenian healthcare system. The total duration of the study will be 24 months. The target number of the inclusion is 2500 patients. The follow-up period for enrolled patients will be 12 months.

Registry
clinicaltrials.gov
Start Date
December 1, 2023
End Date
December 30, 2025
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Armenian Cardiologists Association
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Adult patient (≥ 18 years of age),
  • Admitted to the participating centers for a STEMI within 48 hours of symptom onset: characterized by a rise and fall of cardiac markers (troponins) together with ST elevation in at least two contagious leads or LBBB.
  • Have given signed informed consent to participate in the study.
  • Non-Inclusion Criteria:
  • MI occurring ≤ 48 hours after PCI or CABG
  • The patient or the legal representative refused to sign the informed consent

Exclusion Criteria

  • Withdrawal of the informed consent

Outcomes

Primary Outcomes

Rate of the in-hospital mortality

Time Frame: During 5 to 7 days of hospitalization

Determine the rate of the in-hospital mortality for the patients with STEMI admitted to the participating hospitals

Secondary Outcomes

  • Cardiovascular mortality(30 days and 12 months)
  • All-cause mortality(30 days and 12 months)

Study Sites (13)

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