- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06815913
To Develop and Introduce Into Polyclinic Practice a Register of Patients with Experience of Myocardial Infarction and Acute Cerebrovascular Disease
February 4, 2025 updated by: Pabivantsava Natallia, State Institution "Republican Scientific and Practical Center" Cardiology, Belarus
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.
Study Overview
Status
Active, not recruiting
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 Type
Observational
Enrollment (Estimated)
2000
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Minsk, Belarus, 220036
- Republican Scientific and Practical Center of Cardiology
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
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.
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- No
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
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myocardial infarction
Some patients with non-fatal myocardial infarction
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acute cerebrovascular disease
Hospitalization due to cardiovascular diseases, some patients with hospitalization due to cardiovascular diseases
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mortality from other causes
Time Frame: 3 years
|
number of deaths from other diseases
|
3 years
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Time to combined end point
Time Frame: 3 years
|
non-fatal myocardial infarction or non-fatal cerebral stroke or coronary/carotid revascularization
|
3 years
|
|
Proportion of patients with non-fatal myocardial infarction
Time Frame: 3 years
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non-fatal myocardial infarction
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3 years
|
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Proportion of patients with non-fatal cerebral stroke
Time Frame: 3 years
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non-fatal cerebral stroke
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3 years
|
|
Proportion of patients with COVID-19 cases during follow-up
Time Frame: 3 years
|
COVID-19 cases during follow-up
|
3 years
|
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Hospitalization due to cardiovascular diseases
Time Frame: 3 years
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Proportion of patients with hospitalization due to cardiovascular diseases
|
3 years
|
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COVID-19-related hospitalization
Time Frame: 3 years
|
Pproportion of patients with COVID-19-related hospitalization
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3 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2024
Primary Completion (Estimated)
December 31, 2025
Study Completion (Estimated)
June 1, 2026
Study Registration Dates
First Submitted
February 4, 2025
First Submitted That Met QC Criteria
February 4, 2025
First Posted (Actual)
March 25, 2025
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
February 4, 2025
Last Verified
February 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2161/29590637
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
IPD Plan Description
Protection of personal data
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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