MASTER II - Microvolt T Wave Alternans Testing for Risk Stratification of Post MI Patients
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.
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 positive MTWA test, they will be more 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.
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 Positive result.
Secondary Outcome Measures :
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study:
Child, Adult, Senior
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Patients with a history of heart attacks
LVEF >0.30 and <= 0.40 as measured by a radionuclide study, angiography or quantitative echocardiography within 3 months prior to enrollment.
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