NCT02124018

Risk Stratification in Patients With Preserved Ejection Fraction

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 575 (actual)
• Sponsor: University of Athens · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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%.

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: 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)

Conditions

• Myocardial Infarction

Interventions

Type	Name	Description
PROCEDURE	Programmed ventricular stimulation	Programmed ventricular stimulation in high-risk patients based on non-invasive evaluation
DEVICE	ICD implantation	ICD implantation in patients with induced VT in programmed ventricular stimulation

Timeline

• Start date: 2014-04-01
• Primary completion: 2018-07-31
• Completion: 2018-07-31
• First posted: 2014-04-28
• Last updated: 2019-09-04
• Results posted: 2019-08-26

Locations

1 site across 1 country: Greece