Effect of an Adult EDUcation Program on CArdiovascular ouTcomEs in Post-myocardial-infarction Patients

Not Applicable

• Conditions: Myocardial Infarction
• Interventions: Other: Adult education program

• Registration Number: NCT04007887
• Lead Sponsor: National and Kapodistrian University of Athens

Brief Summary

A non-MD-led adult education program consisting in 10 one-hour sessions designed to provide information and motivation will be offered to patients who have recently been hospitalized for acute myocardial infarction (STEMI and NSTEMI), regarding the management of their treatment and strategies to aggressively optimize control of cardiovascular risk factors..

The intervention arm will be compared to a control group of patients treated with usual care.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-10-15
• Study First Submitted: 2019-06-30
• Status Verified: 2019-07
• Study First Submitted QC: 2019-07-02
• Study First Posted: 2019-07-05
• Last Update Submitted: 2019-07-27
• Last Update Posted: 2019-07-30
• Primary Completion: 2019-12-31
• Study Completion: 2020-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 320

Inclusion Criteria

• History of acute ST-elevation myocardial infarction (STEMI) or non-ST-elevation myocardial infarction (NSTEMI), Type Ι, according to the 3rd Universal Definition of MI, within the preceding 6 weeks
• Absence of substantial cognitive dysfunction (Mini Mental State examination score ≥24)

Exclusion Criteria

• Age >80 years or <18 years

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Adult education program	Post-MI patients attending an adult education program designed to inform and motivate them on how to best control cardiovascular risk factors as a means to offer optimized secondary prevention of cardiovascular events

Primary Outcome Measures

Name	Time	Method
Time to death or myocardial infarction or cerebrovascular event or unplanned hospitalization for cardiovascular reasons	24 months	Time from randomization to the composite endpoint of death or myocardial infarction or cerebrovascular event or unplanned hospitalization for cardiovascular reasons

Secondary Outcome Measures

Name	Time	Method
MACCE	24 months	Major cardio-/cerebro-vascular events (cardiovascular death, myocardial infarction, cerebrovascular event)

Trial Locations

Locations (1)

Athens University Hospital Attikon; 🇬🇷 Athens, Greece