MASTER I - Microvolt T Wave Alternans Testing for Risk Stratification of Post MI Patients

Study Overview
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Brief Summary
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The purpose of the study is to determine the usefulness of microvolt T wave alternans (MTWA) testing of patients that have had a heart attack and have decreased pumping ability of the lower chamber of their heart. MTWA testing is a non-invasive test used to detect the likelihood of developing abnormally fast rhythms in the lower chambers of the heart. The objective of the study is to prove that if a patient has a negative MTWA test, they will be less likely to develop abnormally fast and dangerous rhythms in the lower chambers of the heart. The results of the study will help doctors to determine which patients would benefit the most from having an Implantable Cardioverter Defibrillator (ICD) implanted.

Official Title
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Microvolt T Wave Alternans Testing for Risk Stratification of Post MI Patients (MASTER I)

Conditions
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Myocardial Infarction, Arrhythmia, Ventricular, Ischemic Cardiomyopathy

Intervention / Treatment
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* Procedure: T Wave Alternans Test


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients indicated for an ICD with a history of heart attacks LVEF <= 0.30 as measured by a radionuclide study, angiography or quantitative echocardiography within 3 months prior to enrollment Exclusion Criteria: Patients with electrocardiographically documented sustained ventricular tachycardia, ventricular fibrillation or prior cardiac arrest (Class I indications) Patients who have undergone an electrophysiologic study with ventricular stimulation or a MTWA test within 1 year prior to enrollment Patients with medical conditions that preclude the testing required by the Investigational Plan or limit study participation Patients unable to complete MTWA testing requirements due to current atrial fibrillation or flutter Patients unable to exercise and for which alternative modalities (pacing or pharmacological stress) used for MTWA testing are not available Patients who have experienced an MI within 1 month prior to enrollment Patients with advanced cerebrovascular disease per physician's assessment Patients classified as NYHA Class IV at time of enrollment Patients who have undergone cardiac revascularization within 3 months prior to enrollment or are scheduled for cardiac revascularization at the time of enrollment Patients with a life expectancy of less than 1 year Patients with prior ICD Patients unable to complete follow-up visits at the study center Patients who are enrolled or intend to participate in another clinical study that would compete with the study objectives (assessment will be the responsibility of the Clinical Trial Leader with guidance from the Executive Committee)
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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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: T Wave Alternans Test|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Demonstrate that the life-threatening ventricular tachyarrhythmic event-free survival probability is greater in patients with a baseline MTWA Negative result as compared to patients with a baseline MTWA Non-Negative (Positive or Indeterminate) result. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare occurrence of all ventricular events between both groups |  |  | 
| Identify predictors of life threatening ventricular arrhythmias |  |  | 
| Calculate occurrence of life threatening ventricular arrhythmias based on last MTWA results |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Myocardial Infarction, Microvolt T Wave Alternans Test, Implantable Cardioverter Defibrillator (ICD), Ventricular Arrythmias