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
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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 |
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 [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 |
- Other: No specific intervention
No specific intervention
- 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
- 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.
- All-cause mortality [ Time Frame: 30 days and 12 months ]Compare short-term (30 days) and long-term (12 months) all-cause mortality.
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.
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 |
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.
Inclusion Criteria:
- Adult patient (≥ 18 years of age),
- 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.
- Have given signed informed consent to participate in the study.
Non-Inclusion Criteria:
- MI occurring ≤ 48 hours after PCI or CABG
- The patient or the legal representative refused to sign the informed consent
Exclusion Criteria:
Withdrawal of the informed consent
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
Contact: Hamlet G Hayrapetyan, Prof. | +37493555050 | cardioerebouni@yahoo.com | |
Contact: Hripsime V Poghosyan, Dr. | +37477234994 | hripsime.poghosyan@santearmenie.org |
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 |
Principal Investigator: | Hamlet G Hayrapetyan, Prof. | Armenian Cardiologists Association |
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
STEMI Myocardial infarction acute coronary syndrome CV mortality biobanking |
Myocardial Infarction ST Elevation Myocardial Infarction Infarction Ischemia Pathologic Processes |
Necrosis Myocardial Ischemia Heart Diseases Cardiovascular Diseases Vascular Diseases |