MASTER II - Microvolt T Wave Alternans Testing for Risk Stratification of Post MI Patients - Full Text View

Sponsors and Collaborators:	Medtronic Cardiac Rhythm Disease Management Medtronic
Information provided by:	Medtronic Cardiac Rhythm Disease Management
ClinicalTrials.gov Identifier:	NCT00305214

Purpose

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.

Condition	Intervention
Myocardial Infarction Arrhythmia, Ventricular Ischemic Cardiomyopathy	Procedure: T Wave Alternans Test

Genetics Home Reference related topics: Brugada syndrome short QT syndrome

MedlinePlus related topics: Arrhythmia Cardiomyopathy Heart Attack

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:	Microvolt T Wave Alternans Testing for Risk Stratification of Post MI Patients (MASTER II)

Further study details as provided by Medtronic Cardiac Rhythm Disease Management:

Primary Outcome Measures:

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

Estimated Enrollment:	405
Study Start Date:	October 2003
Study Completion Date:	February 2007
Primary Completion Date:	February 2007 (Final data collection date for primary outcome measure)

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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.

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00305214

Show 47 Study Locations

Sponsors and Collaborators

Medtronic Cardiac Rhythm Disease Management

Medtronic

Investigators

Study Chair:	David G. Benditt, MD	University of Minnesota
Study Chair:	Theodore Chow, MD	The Lindner Center for Research and Education
Study Chair:	Dean J. Kereiakes, MD, FACC	The Lindner Center for Research and Education

More Information

No publications provided

Responsible Party:	Medtronic CRDM Core Clinical ( Brett Peterson / Sr. Clinical Trial Leader )
Study ID Numbers:	220b
Study First Received:	March 20, 2006
Last Updated:	February 11, 2008
ClinicalTrials.gov Identifier:	NCT00305214 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Medtronic Cardiac Rhythm Disease Management:

Myocardial Infarction
Microvolt T Wave Alternans Test
Implantable Cardioverter Defibrillator (ICD)
Ventricular Arrhythmia

Study placed in the following topic categories:

Necrosis
Heart Diseases
Aspirin
Myocardial Ischemia
Vascular Diseases

Ischemia
Infarction
Cardiomyopathies
Myocardial Infarction
Arrhythmias, Cardiac

Additional relevant MeSH terms:

Necrosis
Pathologic Processes
Heart Diseases
Myocardial Ischemia
Vascular Diseases
Cardiovascular Diseases

Ischemia
Infarction
Cardiomyopathies
Myocardial Infarction
Arrhythmias, Cardiac

ClinicalTrials.gov processed this record on May 06, 2009