Risk Stratification in Patients With Preserved Ejection Fraction

Study Overview
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Brief Summary
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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%.

Detailed Description
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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: 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) 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)

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

Conditions
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Myocardial Infarction

Intervention / Treatment
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* Procedure: Programmed ventricular stimulation
* Device: ICD implantation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Post-MI patients<br>Asymptomatic post-MI patients late after MI or 40 days after STEMI-NSTEMI with preserved ejection fraction and absence of active ischemia Programmed ventricular stimulation (PVS) will be performed in high-risk patients based on non-invasive evaluation. ICD implantation will be performed in patients with induced ventricular tachycardia (VT) upon PVS | Procedure: Programmed ventricular stimulation<br>* Programmed ventricular stimulation in high-risk patients based on non-invasive evaluation<br>Device: ICD implantation<br>* ICD implantation in patients with induced VT in programmed ventricular stimulation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Mortality | All-cause mortality | From completion of risk stratification to study completion or outcome occurrence (mean 32 months) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Myocardial infarction, Risk stratification, Sudden cardiac death, Preserved ejection fraction, Programmed ventricular stimulation