Armenian National Registry of Myocardial Infarction

Recruiting

• Conditions: ST Elevation Myocardial Infarction

• Registration Number: NCT06048003
• Lead Sponsor: Armenian Cardiologists Association

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.

Study Timeline

• Status Verified: 2023-09
• Study First Submitted: 2023-09-15
• Study First Submitted QC: 2023-09-15
• Study First Posted: 2023-09-21
• Study Start: 2023-12-01
• Last Update Submitted: 2023-12-22
• Last Update Posted: 2023-12-26
• Primary Completion: 2025-12-01
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2500

Inclusion Criteria

1. Adult patient (≥ 18 years of age),
2. 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.
3. Have given signed informed consent to participate in the study.

Non-Inclusion Criteria:

1. MI occurring ≤ 48 hours after PCI or CABG
2. The patient or the legal representative refused to sign the informed consent

Exclusion Criteria

Withdrawal of the informed consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (13)

Nork Marash Medical Center; 🇦🇲 Yerevan, Armenia

Erebouni Medical Center; 🇦🇲 Yerevan, Armenia

Astghik Medical Center; 🇦🇲 Yerevan, Armenia

Vanadzor Medical Center; 🇦🇲 Vanadzor, Lori, Armenia

Shengavit Medical Center; 🇦🇲 Yerevan, Armenia

French-Armenian Cardiovascular Center; 🇦🇲 Goris, Syunik, Armenia

Best Life Medical Center; 🇦🇲 Yerevan, Armenia

Surb Grigor Lusavorich Medical Center; 🇦🇲 Yerevan, Armenia

Heratsi Hospital Complex N1; 🇦🇲 Yerevan, Armenia

Aramyants Medical Center; 🇦🇲 Yerevan, Armenia

Armenia Medical Center; 🇦🇲 Yerevan, Armenia

Yerevan Scientific Medical Center; 🇦🇲 Yerevan, Armenia

Gyumri Medical Center; 🇦🇲 Gyumri, Shirak, Armenia