N/A
Completed N=523
Risk Stratification in Patients With Preserved Ejection Fraction
Source: ClinicalTrials.gov NCT02124018 ↗Enrolled (actual)
523
Serious AEs
0.0%
Results posted
Aug 2019
Primary outcomePrimary: 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
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%.
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 | — |
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
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. Informational only — not medical advice.