Risk Stratification in Patients With Preserved Ejection Fraction

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

575 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-04-01

Study Completion Date

2018-07-31

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%.

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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:

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)

Conditions

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Myocardial Infarction

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Post-MI patients

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

ICD implantation

Intervention Type DEVICE

ICD implantation in patients with induced VT in programmed ventricular stimulation

Programmed ventricular stimulation

Intervention Type PROCEDURE

Programmed ventricular stimulation in high-risk patients based on non-invasive evaluation

Interventions

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ICD implantation

ICD implantation in patients with induced VT in programmed ventricular stimulation

Intervention Type DEVICE

Programmed ventricular stimulation

Programmed ventricular stimulation in high-risk patients based on non-invasive evaluation

Intervention Type PROCEDURE

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No