ARMI: Armenian National Registry of Myocardial Infarction

Sponsor

Armenian Cardiologists Association (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06048003

Collaborator

Santé Arménie French-Armenian Research Center (Other)

2,500

Enrollment

Location

Anticipated Duration (Months)

100.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
ST Elevation Myocardial Infarction	Other: No specific intervention

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.

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

2500 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Nov 1, 2023

Anticipated Primary Completion Date :

Nov 1, 2025

Anticipated Study Completion Date :

Nov 30, 2025

Outcome Measures

Primary Outcome Measures

Rate of the in-hospital mortality [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 Outcome Measures

Cardiovascular mortality [30 days and 12 months]
Compare short-term (30 days) and long-term (12 months) CV mortality depending on the management strategies.
All-cause mortality [30 days and 12 months]
Compare short-term (30 days) and long-term (12 months) all-cause mortality.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.