Myocardial InfarctionPRESERVE-EFNCT02124018

Risk Stratification in Patients With Preserved Ejection Fraction

An observational study of Myocardial Infarction, run by University of Athens at 1 site in Greece.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The purpose of the study is to assess the prevalence and the prognostic value of non-invasive indexes and programmed ventricular stimulation for sudden cardiac death in post-myocardial infarction (MI) patients with left ventricular ejection fraction (LVEF)>40%. 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?: Programmed ventricular stimulation and ICD implantation
Type of treatment: Medical device, Surgery or procedure
How many people: 575 participants
Where: 1 siteGreece
Study dates: 1 Apr 2014to 31 Jul 2018
How long will I take part?: 3 Years
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Study population: 1000 asymptomatic post-MI patients>40%, at least 40 days post-MI, revascularized or without needing further revascularization (in any case without any evidence of ischemia) The patients will be divided into two categories: 1. Asymptomatic patients with revascularized STEMI (remaining stenoses in non culprit vessels <70%) at 40 days post-MI (when LVEF>40% will be re-assessed) 2. Asymptomatic patients late after MI (initially STEMI-NSTEMI at discharge Q-non Q) with LVEF>40% right after a negative stress test or right after a negative for stenoses control coronary catheterization

Who may be able to join

Asymptomatic patients with revascularized STEMI (remaining stenoses in non culprit vessels <70%) at 40 days post-MI (when LVEF>40% will be re-assessed)
Asymptomatic patients late after MI (initially STEMI-NSTEMI at discharge Q-non Q) with LVEF>40% right after a negative stress test or right after a negative for stenoses control coronary catheterization

Who cannot join

Episodes of sustained VT or aborted sudden cardiac death (SCD) 48 hours after the acute MI phase.
Episodes of syncope within the last 6 months
Cancer, liver failure (cirrhosis), end-stage renal disease
Use of anti-arrhythmic drugs other than b-blockers

Trial locations and contacts

1 site in 1 country.

Greece1 site

First Cardiology Clinic, Hippokration Hospital
Athens, 11527

Other trials in Greece

About this study

Official title: Post Myocardial Infarction Risk Stratification for Sudden Cardiac Death in Patients With Preserved Ejection Fraction: PRESERVE-EF

Read the detailed description

1000 asymptomatic post-MI patients>40%, at least 40 days post-MI, revascularized or without needing further revascularization (in any case without any evidence of ischemia) will be enrolled.

The patients will be divided into two categories:

Asymptomatic patients with revascularized ST-elevation MI (STEMI) (remaining stenoses in non culprit vessels <70%) at 40 days post-MI (when LVEF>40% will be re-assessed)
Asymptomatic patients late (at any time after 40 days) after MI (initially STEMI-NSTEMI at discharge Q-non Q) with LVEF>40% right after a negative stress test or right after a negative for stenoses control coronary catheterization All patients will undergo non-invasive evaluation (ECG, Holter monitoring and 45-min high resolution recording). In case they fulfill at least one out of seven pre-specified criteria they will undergo programmed ventricular stimulation and implantable cardioverter-defibrillator (ICD) implantation (if inducible) All patients will be followed-up for 3 years for sudden cardiac death and its surrogate (appropriate ICD activation)

Conditions: Myocardial Infarction
Being tested: Programmed ventricular stimulation, ICD implantation
Keywords: Myocardial infarction, Risk stratification, Sudden cardiac death, Preserved ejection fraction, Programmed ventricular stimulation
Medical subject headings: Myocardial Infarction, Death, Sudden, Cardiac

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Programmed ventricular stimulationProcedure or surgery
Programmed ventricular stimulation in high-risk patients based on non-invasive evaluation
ICD implantationDevice
ICD implantation in patients with induced VT in programmed ventricular stimulation

Study groups in NCT02124018
Study group	Role	What they receive
Post-MI patients		Asymptomatic post-MI patients late after MI or 40 days after STEMI-NSTEMI with preserved ejection fraction and absence of active ischemia Programmed ventricular stimulation (PVS) will be performed in high-risk patients based on non-invasive evaluation. ICD implantation will be performed in patients with induced ventricular tachycardia (VT) upon PVS Receives: Procedure: Programmed ventricular stimulation; Device: ICD implantation

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Major Arrhythmic Events (MAEs) - Present When One of the Following Occurred: Sudden Cardiac Death, Sustained Ventricular Tachycardia, or Implantable Cardioverter - Defibrillator (ICD) Activation
The number of patients from each risk level group meeting the primary endpoint will be used to assess diagnostic accuracy (positive/negative predictive value, sensitivity and specificity) of the proposed two-stage, PVS-inclusive, risk stratification approach for the allocation of an ICD
Measured: From stratification completion (i.e. allocation to one of three risk level groups) until either occurrence of primary endpoint or study completion (mean 32months) - study stopped early due to emergence of clearly defined high risk subgroup

Secondary outcomes (1)

Total Mortality
All-cause mortality
Measured: From completion of risk stratification to study completion or outcome occurrence (mean 32 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Apr 201431 Jul 2018

First posted28 Apr 2014 (estimated)
Study start1 Apr 2014
Primary completion31 Jul 2018
Study completion31 Jul 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
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: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 575 participants (actual)
Target duration: 3 Years

IDs, dates and publications

ClinicalTrials.gov ID: NCT02124018
Sponsor's protocol ID: UOA-PRESERVE1
Acronym: PRESERVE-EF
Status last verified: Aug 2019
First submitted: 24 Apr 2014
Last updated: 4 Sep 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: Undecided

Publications

Doundoulakis I, Tsiachris D, Arsenos P, Kordalis A, Antoniou CK, Vlachos K, Soulaidopoulos S, Laina A, Kanoupakis E, Dilaveris P, Kolettis TM, Trachanas K, Xenogiannis I, Korantzopoulos P, Sideris S, Fragakis N, Vassilikos VP, Tsioufis K, Gatzoulis KA. Arrhythmic risk stratification in post-myocardial infarction patients with preserved ejection fraction: long-term outcomes from the PRESERVE EF study. Front Cardiovasc Med. 2026 Jul 3;13:1787632. doi: 10.3389/fcvm.2026.1787632. eCollection 2026.
PubMed 42490992
Gatzoulis KA, Tsiachris D, Arsenos P, Antoniou CK, Dilaveris P, Sideris S, Kanoupakis E, Simantirakis E, Korantzopoulos P, Goudevenos I, Flevari P, Iliodromitis E, Sideris A, Vassilikos V, Fragakis N, Trachanas K, Vernardos M, Konstantinou I, Tsimos K, Xenogiannis I, Vlachos K, Saplaouras A, Triantafyllou K, Kallikazaros I, Tousoulis D. Arrhythmic risk stratification in post-myocardial infarction patients with preserved ejection fraction: the PRESERVE EF study. Eur Heart J. 2019 Sep 14;40(35):2940-2949. doi: 10.1093/eurheartj/ehz260.
PubMed 31049557

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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ODSSEY-SCD_Identification Of Markers to preDict the rISk of Sudden Cardiac Death in Moderated LVEF in ischEmic cardiomyopathY
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All Myocardial Infarction trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Post Myocardial Infarction Risk Stratification for Sudden Cardiac Death in Patients With Preserved Ejection Fraction: PRESERVE-EF
ClinicalTrials.gov ID: NCT02124018
Acronym / sponsor ID: PRESERVE-EF / UOA-PRESERVE1
Conditions: Myocardial Infarction
Keywords: Myocardial infarction, Risk stratification, Sudden cardiac death, Preserved ejection fraction, Programmed ventricular stimulation
Study type: Observational
Recruitment status: Completed
Enrolment: 575 participants (actual)
Lead sponsor: University of AthensUniversity, hospital or other
Collaborators: Medtronic, General Electric
Study start: 1 Apr 2014 (actual)
Primary completion: 31 Jul 2018 (actual)
Study completion: 31 Jul 2018 (actual)
First posted: 28 Apr 2014 (estimated)
Results: Posted 26 Aug 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

1000 asymptomatic post-MI patients>40%, at least 40 days post-MI, revascularized or without needing further revascularization (in any case without any evidence of ischemia) will be enrolled.

The patients will be divided into two categories:

Asymptomatic patients with revascularized ST-elevation MI (STEMI) (remaining stenoses in non culprit vessels <70%) at 40 days post-MI (when LVEF>40% will be re-assessed)
Asymptomatic patients late (at any time after 40 days) after MI (initially STEMI-NSTEMI at discharge Q-non Q) with LVEF>40% right after a negative stress test or right after a negative for stenoses control coronary catheterization All patients will undergo non-invasive evaluation (ECG, Holter monitoring and 45-min high resolution recording). In case they fulfill at least one out of seven pre-specified criteria they will undergo programmed ventricular stimulation and implantable cardioverter-defibrillator (ICD) implantation (if inducible) All patients will be followed-up for 3 years for sudden cardiac death and its surrogate (appropriate ICD activation)

Study design

Observational model: Cohort
Time perspective: Prospective
Target follow-up: 3 Years
Number of arms: 1

Arm	Type	Receives
Post-MI patients	–	Procedure: Programmed ventricular stimulation, Device: ICD implantationAsymptomatic post-MI patients late after MI or 40 days after STEMI-NSTEMI with preserved ejection fraction and absence of active ischemia Programmed ventricular stimulation (PVS) will be performed in high-risk patients based on non-invasive evaluation. ICD implantation will be performed in patients with induced ventricular tachycardia (VT) upon PVS

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: 1000 asymptomatic post-MI patients>40%, at least 40 days post-MI, revascularized or without needing further revascularization (in any case without any evidence of ischemia) The patients will be divided into two categories: 1. Asymptomatic patients with revascularized STEMI (remaining stenoses in non culprit vessels <70%) at 40 days post-MI (when LVEF>40% will be re-assessed) 2. Asymptomatic patients late after MI (initially STEMI-NSTEMI at discharge Q-non Q) with LVEF>40% right after a negative stress test or right after a negative for stenoses control coronary catheterization

Key inclusion criteria (2 listed)

Asymptomatic patients with revascularized STEMI (remaining stenoses in non culprit vessels <70%) at 40 days post-MI (when LVEF>40% will be re-assessed)
Asymptomatic patients late after MI (initially STEMI-NSTEMI at discharge Q-non Q) with LVEF>40% right after a negative stress test or right after a negative for stenoses control coronary catheterization

Key exclusion criteria (4 listed)

Episodes of sustained VT or aborted sudden cardiac death (SCD) 48 hours after the acute MI phase.
Episodes of syncope within the last 6 months
Cancer, liver failure (cirrhosis), end-stage renal disease
Use of anti-arrhythmic drugs other than b-blockers

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
Programmed ventricular stimulationProgrammed ventricular stimulation in high-risk patients based on non-invasive evaluation	Procedure or surgery	Post-MI patients
ICD implantationICD implantation in patients with induced VT in programmed ventricular stimulation	Device	Post-MI patients

Primary outcome

Number of Participants With Major Arrhythmic Events (MAEs) - Present When One of the Following Occurred: Sudden Cardiac Death, Sustained Ventricular Tachycardia, or Implantable Cardioverter - Defibrillator (ICD) Activation
Time frame: From stratification completion (i.e. allocation to one of three risk level groups) until either occurrence of primary endpoint or study completion (mean 32months) - study stopped early due to emergence of clearly defined high risk subgroup
The number of patients from each risk level group meeting the primary endpoint will be used to assess diagnostic accuracy (positive/negative predictive value, sensitivity and specificity) of the proposed two-stage, PVS-inclusive, risk stratification approach for the allocation of an ICD

1 secondary outcome

Total Mortality
Time frame: From completion of risk stratification to study completion or outcome occurrence (mean 32 months)

Results and safety

Results posted to the registry on 26 Aug 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Low Risk Group	371	371
Intermediate Risk Group	111	111
High Risk Group	41	41

Primary outcome: Number of Participants With Major Arrhythmic Events (MAEs) - Present When One of the Following Occurred: Sudden Cardiac Death, Sustained Ventricular Tachycardia, or Implantable Cardioverter - Defibrillator (ICD) Activation

Time frame: From stratification completion (i.e. allocation to one of three risk level groups) until either occurrence of primary endpoint or study completion (mean 32months) - study stopped early due to emergence of clearly defined high risk subgroup. Number. Unit: participants

Measure	Low Risk Group n = 371	Intermediate Risk Group n = 111	High Risk Group n = 41
Value	0	0	9

1 secondary outcome is reported in the full results.

Adverse events

Time frame: From stratification completion (allocation to one of risk level groups) to adverse event occurrence, or study completion - mean 32 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Low Risk Group	0 of 371 (0%)	0 of 371 (0%)	0 of 371
Intermediate Risk Group	0 of 111 (0%)	0 of 111 (0%)	4 of 111
High Risk Group	0 of 41 (0%)	0 of 41 (0%)	1 of 41

Limitations and caveats (from the sponsor): Study was not a randomized clinical trial since almost all patients with a per protocol indication received a device, without the presence of a high-risk control group, thus potentially overestimating true arrhythmic risk.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 42490992Doundoulakis I, Tsiachris D, Arsenos P, Kordalis A, Antoniou CK, Vlachos K, Soulaidopoulos S, Laina A, Kanoupakis E, Dilaveris P, Kolettis TM, Trachanas K, Xenogiannis I, Korantzopoulos P, Sideris S, Fragakis N, Vassilikos VP, Tsioufis K, Gatzoulis KA. Arrhythmic risk stratification in post-myocardial infarction patients with preserved ejection fraction: long-term outcomes from the PRESERVE EF study. Front Cardiovasc Med. 2026 Jul 3;13:1787632. doi: 10.3389/fcvm.2026.1787632. eCollection 2026.
Derived from this study: PubMed 31049557Gatzoulis KA, Tsiachris D, Arsenos P, Antoniou CK, Dilaveris P, Sideris S, Kanoupakis E, Simantirakis E, Korantzopoulos P, Goudevenos I, Flevari P, Iliodromitis E, Sideris A, Vassilikos V, Fragakis N, Trachanas K, Vernardos M, Konstantinou I, Tsimos K, Xenogiannis I, Vlachos K, Saplaouras A, Triantafyllou K, Kallikazaros I, Tousoulis D. Arrhythmic risk stratification in post-myocardial infarction patients with preserved ejection fraction: the PRESERVE EF study. Eur Heart J. 2019 Sep 14;40(35):2940-2949. doi: 10.1093/eurheartj/ehz260.
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.

Konstantinos Gatzoulis, MD, PhD principal investigator

University of Athens, Hippokration Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Myocardial Infarction, run by 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 4 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: finished, as of the sponsor's last update on 4 Sep 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?

Yes. Results are posted in the registry (first posted 26 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Major Arrhythmic Events (MAEs) - Present When One of the Following Occurred: Sudden Cardiac Death, Sustained Ventricular Tachycardia, or Implantable Cardioverter - Defibrillator (ICD) Activation (time frame: From stratification completion (i.e. allocation to one of three risk level groups) until either occurrence of primary endpoint or study completion (mean 32months) - study stopped early due to emergence of clearly defined high risk subgroup). 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 NCT02124018, which also lists 2 linked publications.

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 4 Sep 2019.