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NCT04007887 Clinical Trial

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

Myocardial Infarction Clinical Trial

— EDUCATE  

Official title:
Effect of an Adult Education Program on Cardiovascular Outcomes in Post-myocardial-infarction Patients

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04007887
Other study ID # CARD EBD2369/12-05-2017
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 15, 2017
Est. completion date June 30, 2020

Study information
Verified date July 2019
Source National and Kapodistrian University of Athens
Contact Spyridon Deftereos, MD
Phone 00302105832352
Email spdeftereos@med.uoa.gr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 320
Est. completion date June 30, 2020
Est. primary completion date December 31, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- History of acute ST-elevation myocardial infarction (STEMI) or non-ST-elevation myocardial infarction (NSTEMI), Type ?, 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

Related Conditions & MeSH terms

Intervention

Other:
• Adult education program
A 10-hour program embodying major adult education principles, designed to achieve cognitive involvement of patients in their treatment

Locations
Country Name City State
Greece Athens University Hospital Attikon Athens

Sponsors (1)
Lead Sponsor Collaborator
National and Kapodistrian University of Athens

Country where clinical trial is conducted

Greece, 

Outcome
Type Measure Description Time frame Safety issue
Other Change in LDL-chol Change from baseline to 12 months in LDL-cholesterol concentration 12 months
Other Change in body-mass index Change from baseline to 12 months in the body-mass index 12 months
Other Change in arterial pressure Change from baseline to 12 months in systolic arterial pressure (the mean of 3 office measurements) 12 months
Primary Time to death or myocardial infarction or cerebrovascular event or unplanned hospitalization for cardiovascular reasons Time from randomization to the composite endpoint of death or myocardial infarction or cerebrovascular event or unplanned hospitalization for cardiovascular reasons 24 months
Secondary MACCE Major cardio-/cerebro-vascular events (cardiovascular death, myocardial infarction, cerebrovascular event) 24 months
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