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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, Senior
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


  Show 47 Study Locations
Sponsors and Collaborators
Medtronic Cardiac Rhythm and Heart Failure
Medtronic
Investigators
Study Chair: David G. Benditt, MD University of Minnesota - Clinical and Translational Science Institute
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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Brett Peterson / Sr. Clinical Trial Leader, Medtronic CRDM Core Clinical
ClinicalTrials.gov Identifier: NCT00305240     History of Changes
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:
Infarction
Myocardial Infarction
Cardiomyopathies
Ischemia
Pathologic Processes
 Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases