Myocardial Infarction Clinical Trial
— PRESERVE-EFOfficial title:
Post Myocardial Infarction Risk Stratification for Sudden Cardiac Death in Patients With Preserved Ejection Fraction: PRESERVE-EF
NCT number | NCT02124018 |
Other study ID # | UOA-PRESERVE1 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | April 1, 2014 |
Est. completion date | July 31, 2018 |
Verified date | August 2019 |
Source | University of Athens |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
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%.
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 |
Country | Name | City | State |
---|---|---|---|
Greece | First Cardiology Clinic, Hippokration Hospital | Athens |
Lead Sponsor | Collaborator |
---|---|
University of Athens | General Electric, Medtronic |
Greece,
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) |
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