NCT04063176

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2014

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
4.5 years until next milestone

First Submitted

Initial submission to the registry

August 15, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 21, 2019

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2020

Completed
Last Updated

June 11, 2025

Status Verified

June 1, 2025

Enrollment Period

1 year

First QC Date

August 15, 2019

Last Update Submit

June 7, 2025

Conditions

Keywords

myocardial infarction, registry

Outcome Measures

Primary Outcomes (1)

  • time to death, recurrent cardiovascular events (AMI, stroke), emergency hospitalization, lifethreatening arrhythmias.

    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 Outcomes (1)

  • Total mortality

    01.03.2014 - through study completion, an average of 5 year

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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;

You may qualify if:

  • 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.

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Martsevich Yu Sergey, MD, PhD, professor

    National Research Center for Preventive Medicine

    STUDY CHAIR
  • Natalia P Kutishenko

    National Research Center for Preventive Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 15, 2019

First Posted

August 21, 2019

Study Start

March 1, 2014

Primary Completion

March 1, 2015

Study Completion

July 1, 2020

Last Updated

June 11, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share