Myocardial InfarctionEDUCATENCT04007887
Effect of an Adult EDUcation Program on CArdiovascular ouTcomEs in Post-myocardial-infarction Patients
A study testing Adult education program in people with Myocardial Infarction, run by National and Kapodistrian University of Athens at 1 site in Greece.
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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Myocardial Infarction
- What is being tested?
- Adult education program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 1 siteGreece
- Study dates
- 15 Oct 2017to 30 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Age >80 years or <18 years
Trial locations and contacts
1 site in 1 country.
Greece1 site, 1 recruiting
- Recruiting
Athens University Hospital Attikon
Athens, 12462
Spyridon Deftereos
About this study
Official title: Effect of an Adult Education Program on Cardiovascular Outcomes in Post-myocardial-infarction Patients
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.
- Conditions
- Myocardial Infarction
- Being tested
- Adult education program
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adult education programOther
A 10-hour program embodying major adult education principles, designed to achieve cognitive involvement of patients in their treatment
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Adult education program |
| Controls | No intervention | Usual care for post-MI patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 24 months
Secondary outcomes (1)
MACCE
Major cardio-/cerebro-vascular events (cardiovascular death, myocardial infarction, cerebrovascular event)
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2019
- Study start15 Oct 2017
- Primary completion31 Dec 2019 (estimated)
- Study completion30 Jun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by National and Kapodistrian University of AthensThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National and Kapodistrian University of Athens
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Spyridon Deftereos, National and Kapodistrian University of Athens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04007887
- Sponsor's protocol ID
- CARD EBD2369/12-05-2017
- Acronym
- EDUCATE
- Status last verified
- Jul 2019
- First submitted
- 30 Jun 2019
- Last updated
- 30 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 33483355
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of an Adult Education Program on Cardiovascular Outcomes in Post-myocardial-infarction Patients
- ClinicalTrials.gov ID
- NCT04007887
- Acronym / sponsor ID
- EDUCATE / CARD EBD2369/12-05-2017
- Conditions
- Myocardial Infarction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- National and Kapodistrian University of AthensUniversity, hospital or other
- Study start
- 15 Oct 2017 (actual)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 30 Jun 2020 (estimated)
- First posted
- 5 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Adult education programPost-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 |
| Controls | No intervention | –Usual care for post-MI patients |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (1 listed)
- Age >80 years or <18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adult education programA 10-hour program embodying major adult education principles, designed to achieve cognitive involvement of patients in their treatment | Other | Intervention |
Primary outcome
Time to death or myocardial infarction or cerebrovascular event or unplanned hospitalization for cardiovascular reasons
Time frame: 24 months
Time from randomization to the composite endpoint of death or myocardial infarction or cerebrovascular event or unplanned hospitalization for cardiovascular reasons
1 secondary outcome
MACCE
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2019.
- Derived from this study: PubMed 33483355Giannopoulos 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adult education program in people with Myocardial Infarction, run by National and Kapodistrian University of Athens at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Spyridon Deftereos, MD (00302105832352, spdeftereos@med.uoa.gr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to death or myocardial infarction or cerebrovascular event or unplanned hospitalization for cardiovascular reasons (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04007887, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2019.