Acute Cerebrovascular AccidentNCT07159698
Clinical Profile of a Patient After MI and ACVA Based on Outpatient Register Data
An observational study of Acute Cerebrovascular Accident and Myocardial Infarction (MI), 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
- Acute Cerebrovascular Accident, Myocardial Infarction (MI)
- How many people
- 1,520 participants
- Where
- 1 siteBelarus
- Study dates
- 1 Jan 2025to 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 outpatient clinic for any reason between 2019-2022 in order to identify and "look for" patients after acute cardiovascular event and myocardial infarction, meeting the inclusion criteria.
Who may be able to join
- history of MI and/or ACVA of any remoteness;
- visit to the outpatient clinic for any reason during the period from January 1, 2019, to December 31, 2022;
- age 18 years or older;
- the presence of informed consent for the processing of personal data in the outpatient medical record;
- permanent residence in the city where the register is being established.
Who cannot join
- non-compliance with the inclusion criteria.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belarus1 site
Republican Scientific and Practical Center of Cardiology
Minsk, 220036
About this study
Official title: Clinical Profile of a Patient After Myocardial Infarction and Acute Cerebrovascular Accident Based on Outpatient Register Data
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
Abstract The article presents the results of the analysis of outpatient register data of patients after myocardial infarction (MI) and acute cerebrovascular accident (ACVA). Based on the epidemiological characteristics of individuals included in the register, a clinical "portrait of a patient" after an acute cardiovascular event was formed. The features of clinical and laboratory parameters, as well as behavioral and metabolic factors of cardiovascular risk in patients included in the study were determined; and adherence to treatment before and after the reference event was assessed over a 12-year follow-up period.
The objective of the study: to determine the features of clinical and epidemiological characteristics and parameters of laboratory and instrumental studies, the profile of cardiovascular risk factors in patients with a history of MI and ACVA, and to establish their adherence to treatment before and after the reference event over a 12-year follow-up period.
Materials and methods. The investigators analyzed the data of 410 patients who applied to an outpatient and polyclinic healthcare organization between January 1, 2019, and December 31, 2022, with confirmed acute (recurrent) myocardial infarction and/or cerebral infarction that occurred between January 1, 2010, and December 31, 2019. Patients were included in the register after establishing their vital status as of January 1, 2020. The data of records and reports from healthcare organizations (forms 025/u, 131-u) and electronic outpatient records of medical information systems (MIS) from outpatient polyclinic institutions (OPI) were used. The results of the retrospective stage analysis of the study and the electronic patient database from the information and analytical system "Register of MI/ACVA" were presented. Standard methods of descriptive and analytical statistics, statistical software packages (SPSS, SAS, STATISTIKA 10, Stata) and programming languages (R, Python) were used.
- Keywords
- register, myocardial infarction, acute cerebrovascular accident, quality of medical care, outpatient and polyclinic institutions
- Medical subject headings
- Stroke, Myocardial Infarction
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 (MI) | Patients with a history of MI of any remoteness; visit to the outpatient clinic for any reason during the period from January 1, 2019, to December 31, 2022; age 18 years or older; the presence of informed consent for the processing of personal data in the outpatient medical record; and permanent residence in the city where the register is being established. | |
| acute cerebrovascular accident (ACVA) | Patients with a history of ACVA of any remoteness; visit to the outpatient clinic for any reason during the period from January 1, 2019, to December 31, 2022; age 18 years or older; the presence of informed consent for the processing of personal data in the outpatient medical record; and permanent residence in the city where the register is being established. | |
| acute cerebrovascular accident + myocardial infarction (ACVA+MI) | Patients with a history of MI and ACVA of any remoteness; visit to the outpatient clinic for any reason during the period from January 1, 2019, to December 31, 2022; age 18 years or older; the presence of informed consent for the processing of personal data in the outpatient medical record; and permanent residence in the city where the register is being established. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of the main risk factors for the development of heart attacks and/or strokes in the group of studied patients.
For this purpose, primary medical documentation and patient's dispensary observation cards were used. Participants achieved target levels of indicators of the main risk factors according to established standards in accordance with international recommendations.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2025
- Study start1 Jan 2025
- Primary completion1 Oct 2025
- 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 Acute Cerebrovascular AccidentStudies 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
- Case-control
- Time perspective
- Other
- Enrolment
- 1,520 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
- Collaborators
- Belarusian State Medical University
- Responsible party
- Principal investigator, Pabivantsava Natallia, State Institution "Republican Scientific and Practical Center" Cardiology, Belarus
- Investigators
- Elena Grigorenko, Ph.D, Study chair, Republican Scientific and Practical Center of Cardiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07159698
- Sponsor's protocol ID
- 20250326
- Status last verified
- Nov 2025
- First submitted
- 6 Aug 2025
- Last updated
- 24 Nov 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 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Profile of a Patient After Myocardial Infarction and Acute Cerebrovascular Accident Based on Outpatient Register Data
- ClinicalTrials.gov ID
- NCT07159698
- Acronym / sponsor ID
- 20250326
- Keywords
- register, myocardial infarction, acute cerebrovascular accident, quality of medical care, outpatient and polyclinic institutions
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 1,520 participants (estimated)
- Lead sponsor
- State Institution "Republican Scientific and Practical Center" Cardiology, BelarusUniversity, hospital or other
- Collaborators
- Belarusian State Medical University
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 1 Oct 2025 (actual)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 8 Sep 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
Abstract The article presents the results of the analysis of outpatient register data of patients after myocardial infarction (MI) and acute cerebrovascular accident (ACVA). Based on the epidemiological characteristics of individuals included in the register, a clinical "portrait of a patient" after an acute cardiovascular event was formed. The features of clinical and laboratory parameters, as well as behavioral and metabolic factors of cardiovascular risk in patients included in the study were determined; and adherence to treatment before and after the reference event was assessed over a 12-year follow-up period.
The objective of the study: to determine the features of clinical and epidemiological characteristics and parameters of laboratory and instrumental studies, the profile of cardiovascular risk factors in patients with a history of MI and ACVA, and to establish their adherence to treatment before and after the reference event over a 12-year follow-up period.
Materials and methods. The investigators analyzed the data of 410 patients who applied to an outpatient and polyclinic healthcare organization between January 1, 2019, and December 31, 2022, with confirmed acute (recurrent) myocardial infarction and/or cerebral infarction that occurred between January 1, 2010, and December 31, 2019. Patients were included in the register after establishing their vital status as of January 1, 2020. The data of records and reports from healthcare organizations (forms 025/u, 131-u) and electronic outpatient records of medical information systems (MIS) from outpatient polyclinic institutions (OPI) were used. The results of the retrospective stage analysis of the study and the electronic patient database from the information and analytical system "Register of MI/ACVA" were presented. Standard methods of descriptive and analytical statistics, statistical software packages (SPSS, SAS, STATISTIKA 10, Stata) and programming languages (R, Python) were used.
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Target follow-up
- 3 Years
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| myocardial infarction (MI) | – | –Patients with a history of MI of any remoteness; visit to the outpatient clinic for any reason during the period from January 1, 2019, to December 31, 2022; age 18 years or older; the presence of informed consent for the processing of personal data in the outpatient medical record; and permanent residence in the city where the register is being established. |
| acute cerebrovascular accident (ACVA) | – | –Patients with a history of ACVA of any remoteness; visit to the outpatient clinic for any reason during the period from January 1, 2019, to December 31, 2022; age 18 years or older; the presence of informed consent for the processing of personal data in the outpatient medical record; and permanent residence in the city where the register is being established. |
| acute cerebrovascular accident + myocardial infarction (ACVA+MI) | – | –Patients with a history of MI and ACVA of any remoteness; visit to the outpatient clinic for any reason during the period from January 1, 2019, to December 31, 2022; age 18 years or older; the presence of informed consent for the processing of personal data in the outpatient medical record; and permanent residence in the city where the register is being established. |
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 outpatient clinic for any reason between 2019-2022 in order to identify and "look for" patients after acute cardiovascular event and myocardial infarction, meeting the inclusion criteria.
Key inclusion criteria (5 listed)
- history of MI and/or ACVA of any remoteness;
- visit to the outpatient clinic for any reason during the period from January 1, 2019, to December 31, 2022;
- age 18 years or older;
- the presence of informed consent for the processing of personal data in the outpatient medical record;
- permanent residence in the city where the register is being established.
Key exclusion criteria (1 listed)
- non-compliance with the inclusion criteria.
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
Identification of the main risk factors for the development of heart attacks and/or strokes in the group of studied patients.
Time frame: 5 years
For this purpose, primary medical documentation and patient's dispensary observation cards were used. Participants achieved target levels of indicators of the main risk factors according to established standards in accordance with international recommendations.
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 24 Nov 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.
Elena Grigorenko, Ph.D study chair
Republican Scientific and Practical Center of Cardiology
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 Acute Cerebrovascular Accident and Myocardial Infarction (MI), 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 5 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: enrolling by invitation, as of the sponsor's last update on 24 Nov 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?
Identification of the main risk factors for the development of heart attacks and/or strokes in the group of studied patients. (time frame: 5 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 24 Nov 2025.