Armenian National Registry of Myocardial Infarction (ARMI)

December 22, 2023 updated by: Armenian Cardiologists Association

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

2500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Armenia
      • Yerevan, Armenia, 0025
        • Recruiting
        • Heratsi Hospital Complex N1
        • Contact:
          • Hamayak S Sisakyan
      • Yerevan, Armenia, 0087
        • Recruiting
        • Erebouni Medical Center
        • Contact:
          • Hamlet G Hayrapetyan
      • Yerevan, Armenia
        • Recruiting
        • Aramyants Medical Center
        • Contact:
          • Narek Atoyan
      • Yerevan, Armenia
        • Recruiting
        • Armenia Medical Center
        • Contact:
          • Mayranush Drambyan
      • Yerevan, Armenia
        • Recruiting
        • Astghik Medical Center
        • Contact:
          • Zara Kartoyan
      • Yerevan, Armenia
        • Recruiting
        • Best Life Medical Center
        • Contact:
          • Serob Manukian
      • Yerevan, Armenia
        • Recruiting
        • Nork Marash Medical Center
        • Contact:
          • Mikael Adamyan
      • Yerevan, Armenia
        • Recruiting
        • Shengavit Medical Center
        • Contact:
          • Tigran Astvatsatryan
      • Yerevan, Armenia
        • Recruiting
        • Surb Grigor Lusavorich Medical Center
        • Contact:
          • Irina Hovhannisyan
      • Yerevan, Armenia
        • Recruiting
        • Yerevan Scientific Medical Center
        • Contact:
          • Hovhannes Kzhdryan
    • Lori
      • Vanadzor, Lori, Armenia
        • Recruiting
        • Vanadzor Medical Center
        • Contact:
          • Inga Hovhannisyan
    • Shirak
      • Gyumri, Shirak, Armenia
        • Recruiting
        • Gyumri Medical Center
        • Contact:
          • Arthur Stepanyan
    • Syunik
      • Goris, Syunik, Armenia
        • Recruiting
        • French-Armenian Cardiovascular Center
        • Contact:
          • Shahane Musayelyan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of the in-hospital mortality
Time Frame: 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
During 5 to 7 days of hospitalization

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiovascular mortality
Time Frame: 30 days and 12 months
Compare short-term (30 days) and long-term (12 months) CV mortality depending on the management strategies.
30 days and 12 months
All-cause mortality
Time Frame: 30 days and 12 months
Compare short-term (30 days) and long-term (12 months) all-cause mortality.
30 days and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Armenian Cardiologists Association

Collaborators

Santé Arménie French-Armenian Research Center

Investigators

  • Principal Investigator: Hamlet G Hayrapetyan, Prof., Armenian Cardiologists Association

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2023

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 30, 2025

Study Registration Dates

First Submitted

September 15, 2023

First Submitted That Met QC Criteria

September 15, 2023

First Posted (Actual)

September 21, 2023

Study Record Updates

Last Update Posted (Actual)

December 26, 2023

Last Update Submitted That Met QC Criteria

December 22, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ACA-2023001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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