Prospective Outpatient Registry of Myocardial Infarction Patients
PROFILE-MI
1 other identifier
observational
160
0 countries
N/A
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Mar 2014
Longer than P75 for all trials
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
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2015
CompletedFirst Submitted
Initial submission to the registry
August 15, 2019
CompletedFirst Posted
Study publicly available on registry
August 21, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2020
CompletedJune 11, 2025
June 1, 2025
1 year
August 15, 2019
June 7, 2025
Conditions
Keywords
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
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
- Martsevich S.Yu., Kutishenko N.P., Sichinava D.P., Kalaydzhian Е.P. Prospective outpatient registry of myocardial infarction patients (PROFILE-MI): study design and first results (in russian) Cardiovascular Therapy and Prevention, 2018; 17(1): 81-86
- Kutishenko N.P.,Kalaydzhyan E.P.,Sichinava D.P.,Evdakov V.A.,Martsevich S.Yu.OUTPATIENT REGISTRY OF PATIENTS WITH ACUTE MYOCARDIAL INFARCTION(PROFILE-IM):DATA ON PREHOSPITAL THERAPY IN COMPARISON WITH THE LIS-3 REGISTRY.(In Russ.)RPC.2018;14(1):88-93
- Kutishenko N.P., Sichinava D.P.,Kalaydzhyan E.P.,Evdakov V.A.,Kasparova E.A.,Martsevich S.Yu.Effect of Previous Cardiovascular Diseases on Long-Term Outcomes of Acute Myocardial Infarction:Data of the Outpatient Registry"PROFILE-IM". RPС.2018;14(5):741-7
- Martsevich S.Yu., Kutishenko N.P., Kalaydzhyan E.P., Sichinava D.P., Evdakov V.A. Assessment of the Adequacy of Drug Choice in Patients with Acute Myocardial Infarction According to the PROFILE-IM Registry. RPC. 2019;15(2):224-229.(In Russ.)
- Sichinava D.P., Kalaydzhyan E.P., Kutishenko N.P., Martsevich S.Yu. Outpatient Register of Patients with Acute Myocardial Infarction: Assessment of the Hypertension Impact on Long-term Prognosis.RPC.2019;15(5):706-712.(In Russ.)
- Martsevich S.Yu.,Kutishenko N.P.,Sichinava D.P.,Kalaydzhyan E.P. The Main Cardiovascular Complications and Mortality Rates During the First One and a Half Years after Acute Myocardial Infarction: Data from the Prospective Outpatient Registry PROFILE-IM.
- Kalaydzhyan E.P., Martsevich S.Yu., Kutishenko N.P., Sichinava D.P., Drapkina O.M. Untapped Possibilities of Antiischemic Therapy after Acute Myocardial Infarction: Data from the PROFILE-IM Register.RPC. 2020;16(3):432-438. (In Russ.)
- Kalaydzhyan E.P., Kutishenko N.P., Lukina Yu.V., Sichinava D.P., Martsevich S.Yu., Drapkina O.M. The Study of Adherence to Drug Therapy at the Stage of Outpatient Follow-up in Patients with Acute Myocardial Infarction (Data from the PROFIL-IM Registry).
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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
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