MASTER II - Microvolt T Wave Alternans Testing for Risk Stratification of Post MI Patients
Microvolt T Wave Alternans Testing for Risk Stratification of Post MI Patients (MASTER II)
1 other identifier
interventional
405
1 country
47
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2003
Longer than P75 for not_applicable
47 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2003
CompletedFirst Submitted
Initial submission to the registry
March 20, 2006
CompletedFirst Posted
Study publicly available on registry
March 21, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2007
CompletedFebruary 13, 2008
February 1, 2008
3.3 years
March 20, 2006
February 11, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
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
Interventions
Eligibility Criteria
You may qualify if:
- 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.
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Medtronic Cardiac Rhythm and Heart Failurelead
- Medtroniccollaborator
Study Sites (47)
Unknown Facility
Mobile, Alabama, United States
Unknown Facility
Phoenix, Arizona, United States
Unknown Facility
Walnut Creek, California, United States
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Denver, Colorado, United States
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Hartford, Connecticut, United States
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Hollywood, Florida, United States
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Naples, Florida, United States
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Safety Harbor, Florida, United States
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Atlanta, Georgia, United States
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Joliet, Illinois, United States
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Springfield, Illinois, United States
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Beech Grove, Indiana, United States
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Kansas City, Kansas, United States
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New Orleans, Louisiana, United States
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Hyannis, Massachusetts, United States
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Grand Rapids, Michigan, United States
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Saginaw, Michigan, United States
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Saint Joseph, Michigan, United States
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Minneapolis, Minnesota, United States
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Omaha, Nebraska, United States
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Las Vegas, Nevada, United States
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East Islip, New York, United States
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Flushing, New York, United States
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West Islip, New York, United States
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Gastonia, North Carolina, United States
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Greensboro, North Carolina, United States
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High Point, North Carolina, United States
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Raleigh, North Carolina, United States
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Cincinnati, Ohio, United States
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Cleveland, Ohio, United States
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Columbus, Ohio, United States
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Toledo, Ohio, United States
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Doylestown, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Scranton, Pennsylvania, United States
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Spartanburg, South Carolina, United States
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Chattanooga, Tennessee, United States
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Germantown, Tennessee, United States
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Amarillo, Texas, United States
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Corpus Christi, Texas, United States
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Plano, Texas, United States
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Tyler, Texas, United States
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Burlington, Vermont, United States
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Chesapeake, Virginia, United States
Unknown Facility
Portsmouth, Virginia, United States
Unknown Facility
Appleton, Wisconsin, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
March 20, 2006
First Posted
March 21, 2006
Study Start
October 1, 2003
Primary Completion
February 1, 2007
Study Completion
February 1, 2007
Last Updated
February 13, 2008
Record last verified: 2008-02