Risk Stratification in Patients With Preserved Ejection Fraction

Myocardial Infarction Clinical Trial

— PRESERVE-EF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02124018
• Other study ID #: UOA-PRESERVE1
• Status: Completed
• Start date: April 1, 2014
• Est. completion date: July 31, 2018

Study information

• Verified date: August 2019
• Source: University of Athens
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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%.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 575
• Est. completion date: July 31, 2018
• Est. primary completion date: July 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction

Intervention

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

Locations

Country	Name	City	State
Greece	First Cardiology Clinic, Hippokration Hospital	Athens

Sponsors (3)

Lead Sponsor	Collaborator
University of Athens	General Electric, Medtronic

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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	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	Total Mortality	All-cause mortality	From completion of risk stratification to study completion or outcome occurrence (mean 32 months)