Clinical trial NCT06048003: Armenian National Registry of Myocardial Infarction
Official title: Armenian National Registry of ST-elevation Myocardial Infarction,a Multicenter Prospective Observational Study With Biocollection
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: ST Elevation Myocardial Infarction
Keywords: STEMI
Myocardial infarction
acute coronary syndrome
CV mortality
biobanking
Lead sponsor: Armenian Cardiologists Association
Sponsor class: OTHER
Collaborators: name: Santé Arménie French-Armenian Research Center
First posted: 2023-09-21
Enrollment: 2500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The pre-screened population will consist of all patients \>18 years old presenting acutely with suspected STEMI in the participating hospitals.

Only patients with confirmed diagnosis of STEMI will be included in the registry, after informed consent signing.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Rate of the in-hospital mortality
timeFrame: During 5 to 7 days of hospitalization
Secondary outcomes:
measure: Cardiovascular mortality
timeFrame: 30 days and 12 months
measure: All-cause mortality
timeFrame: 30 days and 12 months
Other outcomes:
Locations:
city: Vanadzor
country: Armenia
facility: Vanadzor Medical Center
state: Lori
city: Gyumri
country: Armenia
facility: Gyumri Medical Center
state: Shirak
city: Goris
country: Armenia
facility: French-Armenian Cardiovascular Center
state: Syunik
city: Yerevan
country: Armenia
facility: Heratsi Hospital Complex N1
city: Yerevan
country: Armenia
facility: Erebouni Medical Center
city: Yerevan
country: Armenia
facility: Aramyants Medical Center
city: Yerevan
country: Armenia
facility: Armenia Medical Center
city: Yerevan
country: Armenia
facility: Astghik Medical Center
city: Yerevan
country: Armenia
facility: Best Life Medical Center
city: Yerevan
country: Armenia
facility: Nork Marash Medical Center
city: Yerevan
country: Armenia
facility: Shengavit Medical Center
city: Yerevan
country: Armenia
facility: Surb Grigor Lusavorich Medical Center
city: Yerevan
country: Armenia
facility: Yerevan Scientific Medical Center
Study officials:
affiliation: Armenian Cardiologists Association
name: Hamlet G Hayrapetyan, Prof.
role: PRINCIPAL_INVESTIGATOR
References: