- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00305214
MASTER II - Microvolt T Wave Alternans Testing for Risk Stratification of Post MI Patients
February 11, 2008 updated by: Medtronic Cardiac Rhythm and Heart Failure
Microvolt T Wave Alternans Testing for Risk Stratification of Post MI Patients (MASTER II)
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment
405
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Alabama
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Mobile, Alabama, United States
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Arizona
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Phoenix, Arizona, United States
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California
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Walnut Creek, California, United States
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Colorado
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Denver, Colorado, United States
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Connecticut
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Hartford, Connecticut, United States
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Florida
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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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Georgia
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Atlanta, Georgia, United States
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Illinois
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Joliet, Illinois, United States
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Springfield, Illinois, United States
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Indiana
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Beech Grove, Indiana, United States
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Kansas
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Kansas City, Kansas, United States
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Louisiana
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New Orleans, Louisiana, United States
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Massachusetts
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Hyannis, Massachusetts, United States
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Michigan
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Grand Rapids, Michigan, United States
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Saginaw, Michigan, United States
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St. Joseph, Michigan, United States
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Minnesota
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Minneapolis, Minnesota, United States
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Nebraska
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Omaha, Nebraska, United States
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Nevada
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Las Vegas, Nevada, United States
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New York
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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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North Carolina
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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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Ohio
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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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Pennsylvania
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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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South Carolina
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Spartanburg, South Carolina, United States
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Tennessee
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Chattanooga, Tennessee, United States
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Germantown, Tennessee, United States
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Texas
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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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Vermont
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Burlington, Vermont, United States
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Virginia
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Chesapeake, Virginia, United States
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Portsmouth, Virginia, United States
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Wisconsin
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Appleton, Wisconsin, United States
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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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.
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Secondary Outcome Measures
Outcome Measure |
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Compare occurrence of all ventricular events between both groups
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Identify predictors of life threatening ventricular arrhythmias
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Calculate occurrence of life threatening ventricular arrhythmias based on last MTWA results
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
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
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2003
Primary Completion (Actual)
February 1, 2007
Study Completion (Actual)
February 1, 2007
Study Registration Dates
First Submitted
March 20, 2006
First Submitted That Met QC Criteria
March 20, 2006
First Posted (Estimate)
March 21, 2006
Study Record Updates
Last Update Posted (Estimate)
February 13, 2008
Last Update Submitted That Met QC Criteria
February 11, 2008
Last Verified
February 1, 2008
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 220b
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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