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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06048003
Other study ID # ACA-2023001
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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