The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Armenian National Registry of Myocardial Infarction (ARMI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06048003
Recruitment Status : Recruiting
First Posted : September 21, 2023
Last Update Posted : December 26, 2023
Sponsor:
Collaborator:
Santé Arménie French-Armenian Research Center
Information provided by (Responsible Party):
Armenian Cardiologists Association

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment
ST Elevation Myocardial Infarction Other: No specific intervention

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 Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 2500 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: Armenian National Registry of ST-elevation Myocardial Infarction,a Multicenter Prospective Observational Study With Biocollection
Actual Study Start Date : December 1, 2023
Estimated Primary Completion Date : December 1, 2025
Estimated Study Completion Date : December 30, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Intervention Details:
  • Other: No specific intervention
    No specific intervention

Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.

  2. All-cause mortality [ Time Frame: 30 days and 12 months ]
    Compare short-term (30 days) and long-term (12 months) all-cause mortality.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

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

Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06048003


Contacts
Layout table for location contacts
Contact: Hamlet G Hayrapetyan, Prof. +37493555050 cardioerebouni@yahoo.com
Contact: Hripsime V Poghosyan, Dr. +37477234994 hripsime.poghosyan@santearmenie.org

Locations
Layout table for location information
Armenia
Vanadzor Medical Center Recruiting
Vanadzor, Lori, Armenia
Contact: Inga Hovhannisyan         
Gyumri Medical Center Recruiting
Gyumri, Shirak, Armenia
Contact: Arthur Stepanyan         
French-Armenian Cardiovascular Center Recruiting
Goris, Syunik, Armenia
Contact: Shahane Musayelyan         
Heratsi Hospital Complex N1 Recruiting
Yerevan, Armenia, 0025
Contact: Hamayak S Sisakyan         
Erebouni Medical Center Recruiting
Yerevan, Armenia, 0087
Contact: Hamlet G Hayrapetyan         
Aramyants Medical Center Recruiting
Yerevan, Armenia
Contact: Narek Atoyan         
Armenia Medical Center Recruiting
Yerevan, Armenia
Contact: Mayranush Drambyan         
Astghik Medical Center Recruiting
Yerevan, Armenia
Contact: Zara Kartoyan         
Best Life Medical Center Recruiting
Yerevan, Armenia
Contact: Serob Manukian         
Nork Marash Medical Center Recruiting
Yerevan, Armenia
Contact: Mikael Adamyan         
Shengavit Medical Center Recruiting
Yerevan, Armenia
Contact: Tigran Astvatsatryan         
Surb Grigor Lusavorich Medical Center Recruiting
Yerevan, Armenia
Contact: Irina Hovhannisyan         
Yerevan Scientific Medical Center Recruiting
Yerevan, Armenia
Contact: Hovhannes Kzhdryan         
Sponsors and Collaborators
Armenian Cardiologists Association
Santé Arménie French-Armenian Research Center
Investigators
Layout table for investigator information
Principal Investigator: Hamlet G Hayrapetyan, Prof. Armenian Cardiologists Association
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Layout table for additonal information
Responsible Party: Armenian Cardiologists Association
ClinicalTrials.gov Identifier: NCT06048003    
Other Study ID Numbers: ACA-2023001
First Posted: September 21, 2023    Key Record Dates
Last Update Posted: December 26, 2023
Last Verified: September 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Armenian Cardiologists Association:
STEMI
Myocardial infarction
acute coronary syndrome
CV mortality
biobanking
Additional relevant MeSH terms:
Layout table for MeSH terms
Myocardial Infarction
ST Elevation Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
 Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases