Armenian National Registry of Myocardial Infarction

ST Elevation Myocardial Infarction Clinical Trial

— ARMI  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06048003
• Other study ID #: ACA-2023001
• Status: Recruiting
• Start date: December 1, 2023
• Est. completion date: December 30, 2025

Study information

• Verified date: September 2023
• Source: Armenian Cardiologists Association
• Contact: Hamlet G Hayrapetyan, Prof.
• Phone: +37493555050
• Email: cardioerebouni[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2500
• Est. completion date: December 30, 2025
• Est. primary completion date: December 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction
• ST Elevation Myocardial Infarction

Intervention

Other:
• No specific intervention
No specific intervention

Locations

Country	Name	City	State
Armenia	French-Armenian Cardiovascular Center	Goris	Syunik
Armenia	Gyumri Medical Center	Gyumri	Shirak
Armenia	Vanadzor Medical Center	Vanadzor	Lori
Armenia	Aramyants Medical Center	Yerevan
Armenia	Armenia Medical Center	Yerevan
Armenia	Astghik Medical Center	Yerevan
Armenia	Best Life Medical Center	Yerevan
Armenia	Erebouni Medical Center	Yerevan
Armenia	Heratsi Hospital Complex N1	Yerevan
Armenia	Nork Marash Medical Center	Yerevan
Armenia	Shengavit Medical Center	Yerevan
Armenia	Surb Grigor Lusavorich Medical Center	Yerevan
Armenia	Yerevan Scientific Medical Center	Yerevan

Sponsors (2)

Lead Sponsor	Collaborator
Armenian Cardiologists Association	Santé Arménie French-Armenian Research Center

Country where clinical trial is conducted

Armenia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of the in-hospital mortality	Determine the rate of the in-hospital mortality for the patients with STEMI admitted to the participating hospitals	During 5 to 7 days of hospitalization
Secondary	Cardiovascular mortality	Compare short-term (30 days) and long-term (12 months) CV mortality depending on the management strategies.	30 days and 12 months
Secondary	All-cause mortality	Compare short-term (30 days) and long-term (12 months) all-cause mortality.	30 days and 12 months

External Links

•   Armenian Cardiologists Association official website