ST Elevation Myocardial InfarctionARMINCT06048003
Armenian National Registry of Myocardial Infarction
An observational study of ST Elevation Myocardial Infarction, run by Armenian Cardiologists Association at 13 sites in Armenia.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ST Elevation Myocardial Infarction
- What is being tested?
- No specific intervention
- How many people
- 2,500 participants
- Where
- 13 sitesArmenia
- Study dates
- 1 Dec 2023to 30 Dec 2025
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Withdrawal of the informed consent
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
Armenia13 sites, 13 recruiting
- Recruiting
French-Armenian Cardiovascular Center
Goris, Syunik
Shahane Musayelyan
- Recruiting
Gyumri Medical Center
Gyumri, Shirak
Arthur Stepanyan
- Recruiting
Vanadzor Medical Center
Vanadzor, Lori
Inga Hovhannisyan
- Recruiting
Heratsi Hospital Complex N1
Yerevan, 0025
Hamayak S Sisakyan
- Recruiting
Erebouni Medical Center
Yerevan, 0087
Hamlet G Hayrapetyan
- Recruiting
Aramyants Medical Center
Yerevan
Narek Atoyan
- Recruiting
Armenia Medical Center
Yerevan
Mayranush Drambyan
- Recruiting
Astghik Medical Center
Yerevan
Zara Kartoyan
- Recruiting
Best Life Medical Center
Yerevan
Serob Manukian
- Recruiting
Nork Marash Medical Center
Yerevan
Mikael Adamyan
- Recruiting
Shengavit Medical Center
Yerevan
Tigran Astvatsatryan
- Recruiting
Surb Grigor Lusavorich Medical Center
Yerevan
Irina Hovhannisyan
- Recruiting
Yerevan Scientific Medical Center
Yerevan
Hovhannes Kzhdryan
About this study
Official title: 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.
Read the 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.
- Conditions
- ST Elevation Myocardial Infarction
- Being tested
- No specific intervention
- Keywords
- STEMI, Myocardial infarction, acute coronary syndrome, CV mortality, biobanking
- Medical subject headings
- ST Elevation Myocardial Infarction, Myocardial Infarction, Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No specific interventionOther
No specific intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of the in-hospital mortality
Determine the rate of the in-hospital mortality for the patients with STEMI admitted to the participating hospitals
Measured: During 5 to 7 days of hospitalization
Secondary outcomes (2)
Cardiovascular mortality
Compare short-term (30 days) and long-term (12 months) CV mortality depending on the management strategies.
Measured: 30 days and 12 months
All-cause mortality
Compare short-term (30 days) and long-term (12 months) all-cause mortality.
Measured: 30 days and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start1 Dec 2023
- Primary completion1 Dec 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ST Elevation Myocardial InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,500 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Armenian Cardiologists Association
- Sponsor type
- University, hospital or other
- Collaborators
- Santé Arménie French-Armenian Research Center
- Responsible party
- Sponsor
- Investigators
- Hamlet G Hayrapetyan, Prof., Principal investigator, Armenian Cardiologists Association
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06048003
- Sponsor's protocol ID
- ACA-2023001
- Acronym
- ARMI
- Status last verified
- Sep 2023
- First submitted
- 15 Sep 2023
- Last updated
- 26 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Armenian National Registry of ST-elevation Myocardial Infarction,a Multicenter Prospective Observational Study With Biocollection
- ClinicalTrials.gov ID
- NCT06048003
- Acronym / sponsor ID
- ARMI / ACA-2023001
- Conditions
- ST Elevation Myocardial Infarction
- Keywords
- STEMI, Myocardial infarction, acute coronary syndrome, CV mortality, biobanking
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,500 participants (estimated)
- Lead sponsor
- Armenian Cardiologists AssociationUniversity, hospital or other
- Collaborators
- Santé Arménie French-Armenian Research Center
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 21 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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.
- MI occurring ≤ 48 hours after PCI or CABG
- The patient or the legal representative refused to sign the informed consent
Key exclusion criteria (1 listed)
- Withdrawal of the informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No specific interventionNo specific intervention | Other | – |
Primary outcome
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
2 secondary outcomes
Cardiovascular mortality
Time frame: 30 days and 12 months
All-cause mortality
Time frame: 30 days and 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2023.
- Armenian Cardiologists Association official websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hamlet G Hayrapetyan, Prof. principal investigator
Armenian Cardiologists Association
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ST Elevation Myocardial Infarction, run by Armenian Cardiologists Association at 13 sites in Armenia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Armenia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hamlet G Hayrapetyan, Prof. (+37493555050, cardioerebouni@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of the in-hospital mortality (time frame: During 5 to 7 days of hospitalization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2023.