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

NCT ID: NCT00305240

Last Updated: 2008-02-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 656 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-10-31
• Study Completion Date: 2007-02-28

Brief Summary

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.

Conditions

Myocardial Infarction; Arrhythmia, Ventricular; Ischemic Cardiomyopathy

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Interventions

T Wave Alternans Test

Intervention Type: PROCEDURE

Eligibility Criteria

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)

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic

INDUSTRY

Sponsor Role: collaborator

Medtronic Cardiac Rhythm and Heart Failure

INDUSTRY

Sponsor Role: lead

Responsible Party

Medtronic CRDM Core Clinical

Principal Investigators

David G. Benditt, MD

Role: STUDY_CHAIR

University of Minnesota

Theodore Chow, MD

Role: STUDY_CHAIR

The Lindner Center for Research and Education

Dean J Kereiakes, MD, FACC

Role: STUDY_CHAIR

The Lindner Center for Research and Education

Locations

Mobile, Alabama, United States

Phoenix, Arizona, United States

Walnut Creek, California, United States

Denver, Colorado, United States

Hartford, Connecticut, United States

Hollywood, Florida, United States

Naples, Florida, United States

Safety Harbor, Florida, United States

Atlanta, Georgia, United States

Joliet, Illinois, United States

Springfield, Illinois, United States

Beech Grove, Indiana, United States

Kansas City, Kansas, United States

New Orleans, Louisiana, United States

Hyannis, Massachusetts, United States

Grand Rapids, Michigan, United States

Saginaw, Michigan, United States

Saint Joseph, Michigan, United States

Minneapolis, Minnesota, United States

Omaha, Nebraska, United States

Las Vegas, Nevada, United States

East Islip, New York, United States

Flushing, New York, United States

West Islip, New York, United States

Gastonia, North Carolina, United States

Greensboro, North Carolina, United States

High Point, North Carolina, United States

Raleigh, North Carolina, United States

Cincinnati, Ohio, United States

Cleveland, Ohio, United States

Columbus, Ohio, United States

Toledo, Ohio, United States

Doylestown, Pennsylvania, United States

Philadelphia, Pennsylvania, United States

Pittsburgh, Pennsylvania, United States

Scranton, Pennsylvania, United States

Spartanburg, South Carolina, United States

Chattanooga, Tennessee, United States

Germantown, Tennessee, United States

Amarillo, Texas, United States

Corpus Christi, Texas, United States

Plano, Texas, United States

Tyler, Texas, United States

Burlington, Vermont, United States

Chesapeake, Virginia, United States

Portsmouth, Virginia, United States

Appleton, Wisconsin, United States

Countries

United States

References

Chow T, Kereiakes DJ, Onufer J, Woelfel A, Gursoy S, Peterson BJ, Brown ML, Pu W, Benditt DG; MASTER Trial Investigators. Does microvolt T-wave alternans testing predict ventricular tachyarrhythmias in patients with ischemic cardiomyopathy and prophylactic defibrillators? The MASTER (Microvolt T Wave Alternans Testing for Risk Stratification of Post-Myocardial Infarction Patients) trial. J Am Coll Cardiol. 2008 Nov 11;52(20):1607-15. doi: 10.1016/j.jacc.2008.08.018.

Reference Type: DERIVED

PMID: 18992649 (View on PubMed)

Other Identifiers

220a

Identifier Type: -

Identifier Source: org_study_id