MASTER I - 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. |
ClinicalTrials.gov Identifier: NCT00305240 |
Recruitment Status :
Completed
First Posted : March 21, 2006
Last Update Posted : February 13, 2008
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Myocardial Infarction Arrhythmia, Ventricular Ischemic Cardiomyopathy | Procedure: T Wave Alternans Test | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 656 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Diagnostic |
Official Title: | Microvolt T Wave Alternans Testing for Risk Stratification of Post MI Patients (MASTER I) |
Study Start Date : | October 2003 |
Actual Primary Completion Date : | February 2007 |
Actual Study Completion Date : | February 2007 |
- 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.
- 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, Older Adult |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00305240
United States, Alabama | |
Mobile, Alabama, United States | |
United States, Arizona | |
Phoenix, Arizona, United States | |
United States, California | |
Walnut Creek, California, United States | |
United States, Colorado | |
Denver, Colorado, United States | |
United States, Connecticut | |
Hartford, Connecticut, United States | |
United States, Florida | |
Hollywood, Florida, United States | |
Naples, Florida, United States | |
Safety Harbor, Florida, United States | |
United States, Georgia | |
Atlanta, Georgia, United States | |
United States, Illinois | |
Joliet, Illinois, United States | |
Springfield, Illinois, United States | |
United States, Indiana | |
Beech Grove, Indiana, United States | |
United States, Kansas | |
Kansas City, Kansas, United States | |
United States, Louisiana | |
New Orleans, Louisiana, United States | |
United States, Massachusetts | |
Hyannis, Massachusetts, United States | |
United States, Michigan | |
Grand Rapids, Michigan, United States | |
Saginaw, Michigan, United States | |
St. Joseph, Michigan, United States | |
United States, Minnesota | |
Minneapolis, Minnesota, United States | |
United States, Nebraska | |
Omaha, Nebraska, United States | |
United States, Nevada | |
Las Vegas, Nevada, United States | |
United States, New York | |
East Islip, New York, United States | |
Flushing, New York, United States | |
West Islip, New York, United States | |
United States, North Carolina | |
Gastonia, North Carolina, United States | |
Greensboro, North Carolina, United States | |
High Point, North Carolina, United States | |
Raleigh, North Carolina, United States | |
United States, Ohio | |
Cincinnati, Ohio, United States | |
Cleveland, Ohio, United States | |
Columbus, Ohio, United States | |
Toledo, Ohio, United States | |
United States, Pennsylvania | |
Doylestown, Pennsylvania, United States | |
Philadelphia, Pennsylvania, United States | |
Pittsburgh, Pennsylvania, United States | |
Scranton, Pennsylvania, United States | |
United States, South Carolina | |
Spartanburg, South Carolina, United States | |
United States, Tennessee | |
Chattanooga, Tennessee, United States | |
Germantown, Tennessee, United States | |
United States, Texas | |
Amarillo, Texas, United States | |
Corpus Christi, Texas, United States | |
Plano, Texas, United States | |
Tyler, Texas, United States | |
United States, Vermont | |
Burlington, Vermont, United States | |
United States, Virginia | |
Chesapeake, Virginia, United States | |
Portsmouth, Virginia, United States | |
United States, Wisconsin | |
Appleton, Wisconsin, United States |
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 |
Responsible Party: | Brett Peterson / Sr. Clinical Trial Leader, Medtronic CRDM Core Clinical |
ClinicalTrials.gov Identifier: | NCT00305240 |
Other Study ID Numbers: |
220a |
First Posted: | March 21, 2006 Key Record Dates |
Last Update Posted: | February 13, 2008 |
Last Verified: | February 2008 |
Myocardial Infarction Microvolt T Wave Alternans Test Implantable Cardioverter Defibrillator (ICD) Ventricular Arrythmias |
Myocardial Infarction Cardiomyopathies Arrhythmias, Cardiac Infarction Ischemia Pathologic Processes |
Necrosis Myocardial Ischemia Heart Diseases Cardiovascular Diseases Vascular Diseases |