Myocardial Infarction (MI)NCT06815913
To Develop and Introduce Into Polyclinic Practice a Register of Patients with Experience of Myocardial Infarction and Acute Cerebrovascular Disease
An observational study of Myocardial Infarction (MI) and Acute Cardiovascular Disease, run by State Institution "Republican Scientific and Practical Center" Cardiology, Belarus at 1 site in Belarus.
Trial summary
This is a retrospective observational study using the methodology of creating medical registries. The expected number of patients included in the registry is about 2000 patients with myocardial infarction and/or ACVD of any duration and concomitant non-cardiac diseases of therapeutic profile in pilot healthcare… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Infarction (MI), Acute Cardiovascular Disease
- How many people
- 2,000 participants
- Where
- 1 siteBelarus
- Study dates
- 1 Mar 2024to 1 Jun 2026
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: All patients who applied to the pilot ambulatory health care organizations between 2019-2022 in order to identify and "look for" patients after acute cardiovascular event, but who were not monitored for that event for various reasons (statute of limitations, refusal, relocation, etc.); meeting the inclusion criteria and not meeting the exclusion criteria.
Who may be able to join
- All patients who applied to the pilot ambulatory health care organizations between 2019-2022 in order to identify and "look for" patients after acute cardiovascular event, but who were not monitored for that event for various reasons (statute of limitations, refusal, relocation, etc.);
- All patients discharged from hospitals with a final diagnosis of AMI/ACVD, assigned territorially to the pilot polyclinics in the period 2019-2022.
- Presence of a history of AMI and/or ACVD;
- Age 18 years and older.
Who cannot join
- No
Trial locations and contacts
1 site in 1 country.
Belarus1 site
Republican Scientific and Practical Center of Cardiology
Minsk, 220036
About this study
This is a retrospective observational study using the methodology of creating medical registries. The expected number of patients included in the registry is about 2000 patients with myocardial infarction and/or ACVD of any duration and concomitant non-cardiac diseases of therapeutic profile in pilot healthcare organizations for any reason during 2019-2022 based on the source medical records data.
Read the detailed description
The implementation of the task results will improve the efficiency of secondary and tertiary prevention of diseases of the circulatory system - pathology that makes the greatest contribution to the main medical-demographic and socio-economic losses of the state by determining the number of groups with the highest risk of death in outpatient and polyclinic institutions among patients after myocardial infarction, ACVD, living in the Republic of Belarus, to create programs of additional measures to reduce morbidity and mortality of the population based on a comparison of register data and official statistical forms, which will ultimately affect the reduction in the incidence of non-fatal recurrent cardiovascular events in individuals after AMI, ACVD and / or their combination of any duration in the range of 0.2-1% of the indicators determined during the study.
- Keywords
- registry, multimorbidity, chronic non-communicable diseases, cardiovascular diseases, myocardial infarction, acute cerebrovascular disease
- Medical subject headings
- Myocardial Infarction, Noncommunicable Diseases, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| myocardial infarction | Some patients with non-fatal myocardial infarction | |
| acute cerebrovascular disease | Hospitalization due to cardiovascular diseases, some patients with hospitalization due to cardiovascular diseases |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality from other causes
number of deaths from other diseases
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2025
- Study start1 Mar 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial Infarction (MI)Studies 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
- Other
- Enrolment
- 2,000 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- State Institution "Republican Scientific and Practical Center" Cardiology, Belarus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pabivantsava Natallia, State Institution "Republican Scientific and Practical Center" Cardiology, Belarus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06815913
- Sponsor's protocol ID
- 2161/29590637
- Status last verified
- Feb 2025
- First submitted
- 4 Feb 2025
- Last updated
- 10 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Protection of personal data
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Develop and Introduce Into Polyclinic Practice a Register of Patients with Experience of Myocardial Infarction and Acute Cerebrovascular Disease
- ClinicalTrials.gov ID
- NCT06815913
- Acronym / sponsor ID
- 2161/29590637
- Keywords
- registry, multimorbidity, chronic non-communicable diseases, cardiovascular diseases, myocardial infarction, acute cerebrovascular disease
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- State Institution "Republican Scientific and Practical Center" Cardiology, BelarusUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 10 Feb 2025 (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 retrospective observational study using the methodology of creating medical registries. The expected number of patients included in the registry is about 2000 patients with myocardial infarction and/or ACVD of any duration and concomitant non-cardiac diseases of therapeutic profile in pilot healthcare organizations for any reason during 2019-2022 based on the source medical records data.
Detailed description
The implementation of the task results will improve the efficiency of secondary and tertiary prevention of diseases of the circulatory system - pathology that makes the greatest contribution to the main medical-demographic and socio-economic losses of the state by determining the number of groups with the highest risk of death in outpatient and polyclinic institutions among patients after myocardial infarction, ACVD, living in the Republic of Belarus, to create programs of additional measures to reduce morbidity and mortality of the population based on a comparison of register data and official statistical forms, which will ultimately affect the reduction in the incidence of non-fatal recurrent cardiovascular events in individuals after AMI, ACVD and / or their combination of any duration in the range of 0.2-1% of the indicators determined during the study.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 3 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| myocardial infarction | – | –Some patients with non-fatal myocardial infarction |
| acute cerebrovascular disease | – | –Hospitalization due to cardiovascular diseases, some patients with hospitalization due to cardiovascular diseases |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients who applied to the pilot ambulatory health care organizations between 2019-2022 in order to identify and "look for" patients after acute cardiovascular event, but who were not monitored for that event for various reasons (statute of limitations, refusal, relocation, etc.); meeting the inclusion criteria and not meeting the exclusion criteria.
Key inclusion criteria (4 listed)
- All patients who applied to the pilot ambulatory health care organizations between 2019-2022 in order to identify and "look for" patients after acute cardiovascular event, but who were not monitored for that event for various reasons (statute of limitations, refusal, relocation, etc.);
- All patients discharged from hospitals with a final diagnosis of AMI/ACVD, assigned territorially to the pilot polyclinics in the period 2019-2022.
- Presence of a history of AMI and/or ACVD;
- Age 18 years and older.
Key exclusion criteria (1 listed)
- No
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mortality from other causes
Time frame: 3 years
number of deaths from other diseases
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2025.
- Individual participant dataSharing planned: Undecided. Protection of personal data
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myocardial Infarction (MI) and Acute Cardiovascular Disease, run by State Institution "Republican Scientific and Practical Center" Cardiology, Belarus at 1 site in Belarus.
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 4 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: under way, not looking for participants, as of the sponsor's last update on 10 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belarus. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality from other causes (time frame: 3 years). 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 10 Feb 2025.