Prospective Outpatient Registry of Myocardial Infarction Patients

Myocardial Infarction Clinical Trial

— PROFILE-MI  

Official title:

Prospective Outpatient Registry of Myocardial Infarction Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04063176
• Other study ID #: PROFILE-MI
• Status: Completed
• Start date: March 1, 2014
• Est. completion date: July 1, 2020

Study information

• Verified date: July 2020
• Source: National Research Center for Preventive Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: July 1, 2020
• Est. primary completion date: March 1, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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;

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
National Research Center for Preventive Medicine

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Total mortality	Determination of total mortality for any reason of patients enrolled in the Registry	01.03.2014 - through study completion, an average of 5 year

External Links

•   Martsevich S.Yu., Kutishenko N.P., Sichinava D.P., Kalaydzhian ?.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