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

Completed · Not applicable

Conditions studied: Myocardial Infarction, Arrhythmia, Ventricular, Ischemic Cardiomyopathy

In brief

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.

Key facts

Study ID

NCT00305240

Run by

Medtronic Cardiac Rhythm and Heart Failure

People needed

656

Starts

2003-10-01

Expected to finish

2007-02-01

Last updated by the study team

2008-02-13

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• Study site — Mobile, Alabama, United States
• Study site — Phoenix, Arizona, United States
• Study site — Walnut Creek, California, United States
• Study site — Denver, Colorado, United States
• Study site — Hartford, Connecticut, United States
• Study site — Hollywood, Florida, United States
• Study site — Naples, Florida, United States
• Study site — Safety Harbor, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Joliet, Illinois, United States
• Study site — Springfield, Illinois, United States
• Study site — Beech Grove, Indiana, United States
• Study site — Kansas City, Kansas, United States
• Study site — New Orleans, Louisiana, United States
• Study site — Hyannis, Massachusetts, United States
• Study site — Grand Rapids, Michigan, United States
• Study site — Saginaw, Michigan, United States
• Study site — Saint Joseph, Michigan, United States
• Study site — Minneapolis, Minnesota, United States
• Study site — Omaha, Nebraska, United States
• Study site — Las Vegas, Nevada, United States
• Study site — East Islip, New York, United States
• Study site — Flushing, New York, United States
• Study site — West Islip, New York, United States
• Study site — Gastonia, North Carolina, United States

Full record on ClinicalTrials.gov

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