N/A N=523

Risk Stratification in Patients With Preserved Ejection Fraction

Myocardial Infarction

Bottom Line

View on ClinicalTrials.gov: NCT02124018 ↗

Enrolled (actual)

523

Serious AEs

0.0%

Results posted

Aug 2019

Primary outcome: Primary: 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 — 0; 0; 9 participants

Study Design & Population

Study type: Observational
Phase: N/A
Interventions: Programmed ventricular stimulation (Procedure); ICD implantation (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Athens
Primary completion: Jul 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY 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	0; 0; 9	—
SECONDARY Total Mortality	0; 4; 1	—

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%.

Eligibility Criteria

Inclusion Criteria

Asymptomatic patients with revascularized STEMI (remaining stenoses in non culprit vessels 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02124018). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.