Prospective Outpatient Registry of Myocardial Infarction Patients (PROFILE-MI)

June 7, 2025 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

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.

Sponsor

National Research Center for Preventive Medicine

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.

Helpful Links

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)

June 11, 2025

Last Update Submitted That Met QC Criteria

June 7, 2025

Last Verified

June 1, 2025

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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