- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04063176
Prospective Outpatient Registry of Myocardial Infarction Patients (PROFILE-MI)
July 29, 2020 updated by: National Research Center for Preventive Medicine
The investigators enrolled 160 patients who visited Moscow state outpatient clinic №9 (and its two branches) within six months after acute myocardial infarction.
The enrollment lasted from 01.03.2014 to 01.07.2015.
The observation period is five years.
During the first year after enrollment in the study, patients had follow-up visits every two months, from second-year every six months.
Analysis of the prescribed therapy and its changes was carried out by the cardiologist in the clinic for the entire observation period, taking into account the concomitant diseases /indications/contraindications.
Endpoints (the death, repeated cardiovascular complications (AMI, stroke), emergency hospitalization due to worsening of the main cardiovascular disease, the appearance of clinically significant cardiac arrhythmias, invasive interventions) were defined during out-patient visits and telephone contact
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
160
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
18 years to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
patients who have undergone AMI and applied no later than 6 months after discharge from the hospital to the outpatient clinic № 9 or its branches from March 1, 2014 to December 31, 2015;
Description
Inclusion Criteria:
- patients who have undergone AMI and applied no later than 6 months. after discharge from the hospital to the Moscow outpatient clinic № 9 from March 1, 2014, to December 31, 2015;
- availability of discharge summary with confirmed AMI;
- permanent residence on the territory of Moscow and the Moscow region;
- the signing of informed consent to the processing of personal data.
Exclusion Criteria:
- patients with the absence of discharge summary from the hospital with a proven history of AMI;
- visit the clinic in a period exceeding six months from the AMI;
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
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
time to death, recurrent cardiovascular events (AMI, stroke), emergency hospitalization, lifethreatening arrhythmias.
Time Frame: 01.03.2014 - through study completion, an average of 5 year
|
According to the results of monitoring will be determined a combined endpoint: the death, recurrent cardiovascular events, emergency hospitalization, lifethreatening arrhythmias
|
01.03.2014 - through study completion, an average of 5 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Total mortality
Time Frame: 01.03.2014 - through study completion, an average of 5 year
|
Determination of total mortality for any reason of patients enrolled in the Registry
|
01.03.2014 - through study completion, an average of 5 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Martsevich Yu Sergey, MD, PhD, professor, National Research Center for Preventive Medicine
- Principal Investigator: Natalia P Kutishenko, National Research Center for Preventive Medicine
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the 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, 2014
Primary Completion (Actual)
March 1, 2015
Study Completion (Actual)
July 1, 2020
Study Registration Dates
First Submitted
August 15, 2019
First Submitted That Met QC Criteria
August 19, 2019
First Posted (Actual)
August 21, 2019
Study Record Updates
Last Update Posted (Actual)
July 30, 2020
Last Update Submitted That Met QC Criteria
July 29, 2020
Last Verified
July 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PROFILE-MI
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
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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