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

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ClinicalTrials.gov Identifier: NCT00305240
Recruitment Status : Completed
First Posted : March 21, 2006
Last Update Posted : February 13, 2008
Sponsor:
Collaborator:
Medtronic
Information provided by:
Medtronic Cardiac Rhythm and Heart Failure

Study Description
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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.

Condition or disease Intervention/treatment Phase
Myocardial Infarction Arrhythmia, Ventricular Ischemic Cardiomyopathy Procedure: T Wave Alternans Test Not Applicable

Study Design
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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
Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  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 Non-Negative (Positive or Indeterminate) result.

Secondary Outcome Measures :
  1. Compare occurrence of all ventricular events between both groups
  2. Identify predictors of life threatening ventricular arrhythmias
  3. Calculate occurrence of life threatening ventricular arrhythmias based on last MTWA results

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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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
Sponsors and Collaborators
Medtronic Cardiac Rhythm and Heart Failure
Medtronic
Investigators
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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
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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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
Keywords provided by Medtronic Cardiac Rhythm and Heart Failure:
Myocardial Infarction
Microvolt T Wave Alternans Test
Implantable Cardioverter Defibrillator (ICD)
Ventricular Arrythmias
Additional relevant MeSH terms:
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Myocardial Infarction
Cardiomyopathies
Arrhythmias, Cardiac
Infarction
Ischemia
Pathologic Processes
 Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases