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

Primary Purpose

Myocardial Infarction

Status
Unknown status
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
Adult education program
Sponsored by
National and Kapodistrian University of Athens
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Myocardial Infarction

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Athens University Hospital AttikonRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Controls

Arm Description

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

Usual care for post-MI patients

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

MACCE
Major cardio-/cerebro-vascular events (cardiovascular death, myocardial infarction, cerebrovascular event)

Full Information

First Posted
June 30, 2019
Last Updated
July 27, 2019
Sponsor
National and Kapodistrian University of Athens
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1. Study Identification

Unique Protocol Identification Number
NCT04007887
Brief Title
Effect of an Adult EDUcation Program on CArdiovascular ouTcomEs in Post-myocardial-infarction Patients
Acronym
EDUCATE
Official Title
Effect of an Adult Education Program on Cardiovascular Outcomes in Post-myocardial-infarction Patients
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Unknown status
Study Start Date
October 15, 2017 (Actual)
Primary Completion Date
December 31, 2019 (Anticipated)
Study Completion Date
June 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National and Kapodistrian University of Athens

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
320 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
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
Arm Title
Controls
Arm Type
No Intervention
Arm Description
Usual care for post-MI patients
Intervention Type
Other
Intervention Name(s)
Adult education program
Intervention Description
A 10-hour program embodying major adult education principles, designed to achieve cognitive involvement of patients in their treatment
Primary Outcome Measure Information:
Title
Time to death or myocardial infarction or cerebrovascular event or unplanned hospitalization for cardiovascular reasons
Description
Time from randomization to the composite endpoint of death or myocardial infarction or cerebrovascular event or unplanned hospitalization for cardiovascular reasons
Time Frame
24 months
Secondary Outcome Measure Information:
Title
MACCE
Description
Major cardio-/cerebro-vascular events (cardiovascular death, myocardial infarction, cerebrovascular event)
Time Frame
24 months
Other Pre-specified Outcome Measures:
Title
Change in LDL-chol
Description
Change from baseline to 12 months in LDL-cholesterol concentration
Time Frame
12 months
Title
Change in body-mass index
Description
Change from baseline to 12 months in the body-mass index
Time Frame
12 months
Title
Change in arterial pressure
Description
Change from baseline to 12 months in systolic arterial pressure (the mean of 3 office measurements)
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Spyridon Deftereos, MD
Phone
00302105832352
Email
spdeftereos@med.uoa.gr
Facility Information:
Facility Name
Athens University Hospital Attikon
City
Athens
ZIP/Postal Code
12462
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Spyridon Deftereos

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
33483355
Citation
Giannopoulos G, Karageorgiou S, Vrachatis D, Anagnostopoulos I, Kousta MS, Lakka E, Giotaki S, Raisakis K, Sianos G, Toutouzas K, Cleman M, Deftereos S. A stand-alone structured educational programme after myocardial infarction: a randomised study. Heart. 2021 Jan 22:heartjnl-2020-318414. doi: 10.1136/heartjnl-2020-318414. Online ahead of print.
Results Reference
derived

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

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