Ignite Creation Date:
2024-05-06 @ 2:47 AM
Last Modification Date:
2024-10-26 @ 11:23 AM
Study NCT ID:
NCT02124018
Status:
COMPLETED
Last Update Posted:
2019-09-04
First Post:
2014-04-24
Brief Title:
Risk Stratification in Patients With Preserved Ejection Fraction
Sponsor:
University of Athens
Organization:
University of Athens
Study Overview
Official Title:
Post Myocardial Infarction Risk Stratification for Sudden Cardiac Death in Patients With Preserved Ejection Fraction PRESERVE-EF
Status:
COMPLETED
Status Verified Date:
2019-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PRESERVE-EF
Brief 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 LVEF40
Detailed Description:
1000 asymptomatic post-MI patients40 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 LVEF40 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 LVEF40 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
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 LVEF40 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 LVEF40 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None