Risk Stratification in Patients With Preserved Ejection Fraction (PRESERVE-EF)
August 23, 2019 updated by: Kostantinos A. Gatzoulis, University of Athens
Post Myocardial Infarction Risk Stratification for Sudden Cardiac Death in Patients With Preserved Ejection Fraction: PRESERVE-EF
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%.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Actual)
575
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Athens, Greece, 11527
- First Cardiology Clinic, Hippokration Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
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:
- 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
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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 |
Programmed ventricular stimulation in high-risk patients based on non-invasive evaluation
ICD implantation in patients with induced VT in programmed ventricular stimulation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Total Mortality
Time Frame: From completion of risk stratification to study completion or outcome occurrence (mean 32 months)
|
All-cause mortality
|
From completion of risk stratification to study completion or outcome occurrence (mean 32 months)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Konstantinos Gatzoulis, MD, PhD, University of Athens, Hippokration Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2014
Primary Completion (Actual)
July 31, 2018
Study Completion (Actual)
July 31, 2018
Study Registration Dates
First Submitted
April 24, 2014
First Submitted That Met QC Criteria
April 24, 2014
First Posted (Estimate)
April 28, 2014
Study Record Updates
Last Update Posted (Actual)
September 4, 2019
Last Update Submitted That Met QC Criteria
August 23, 2019
Last Verified
August 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- UOA-PRESERVE1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.