Risk Stratification in Patients With Preserved Ejection Fraction (PRESERVE-EF)

National and Kapodistrian University of Athens

Status: Completed

Conditions: Myocardial Infarction

Treatments: Device: ICD implantation; Procedure: Programmed ventricular stimulation

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT02124018

UOA-PRESERVE1

Details and patient eligibility

About

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%.

Full 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:

1. 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)
2. 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)

Enrollment: 575 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

575 participants in 1 patient group

Post-MI patients

Description:

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

Treatment:

Device: ICD implantation

Procedure: Programmed ventricular stimulation