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
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction

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