NCT04007887

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
320

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 15, 2017

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

June 30, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 5, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2020

Completed
Last Updated

July 30, 2019

Status Verified

July 1, 2019

Enrollment Period

2.2 years

First QC Date

June 30, 2019

Last Update Submit

July 27, 2019

Conditions

Myocardial Infarction

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • MACCE

    24 months

Other Outcomes (3)

  • Change in LDL-chol

    12 months

  • Change in body-mass index

    12 months

  • Change in arterial pressure

    12 months

Study Arms (2)

Intervention

EXPERIMENTAL

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

Other: Adult education program

Controls

NO INTERVENTION

Usual care for post-MI patients

Interventions

Adult education programOTHER

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

Intervention

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • \- Age \>80 years or \<18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Athens University Hospital Attikon

Athens, 12462, Greece

RECRUITING

Related Publications (1)

  • 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 Jun 11;107(13):1047-1053. doi: 10.1136/heartjnl-2020-318414.

    PMID: 33483355DERIVED

MeSH Terms

Conditions

Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Central Study Contacts

Spyridon Deftereos, MD

CONTACT

00302105832352spdeftereos@med.uoa.gr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Cardiology

Study Record Dates

First Submitted

June 30, 2019

First Posted

July 5, 2019

Study Start

October 15, 2017

Primary Completion

December 31, 2019

Study Completion

June 30, 2020

Last Updated

July 30, 2019

Record last verified: 2019-07

Locations

GR(1)