Text Size

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

This study has been completed.
Sponsor:
Collaborator:
Medtronic
Information provided by:
Medtronic Cardiac Rhythm Disease Management
ClinicalTrials.gov Identifier:
NCT00305240
First received: March 20, 2006
Last updated: February 11, 2008
Last verified: February 2008
History of Changes
  Purpose

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 Intervention
Myocardial Infarction
Arrhythmia, Ventricular
Ischemic Cardiomyopathy
 Procedure: T Wave Alternans Test

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Microvolt T Wave Alternans Testing for Risk Stratification of Post MI Patients (MASTER I)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Medtronic Cardiac Rhythm Disease Management:

Primary Outcome Measures:
  • 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:
  • 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

Estimated Enrollment: 656
Study Start Date: October 2003
Study Completion Date: February 2007
Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)
  Eligibility

Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00305240

  Show 47 Study Locations
Sponsors and Collaborators
Medtronic Cardiac Rhythm Disease Management
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

No publications provided by Medtronic Cardiac Rhythm Disease Management

Additional 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
Study First Received: March 20, 2006
Last Updated: February 11, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Medtronic Cardiac Rhythm Disease Management:
Myocardial Infarction
Microvolt T Wave Alternans Test
Implantable Cardioverter Defibrillator (ICD)
Ventricular Arrythmias

Additional relevant MeSH terms:
Arrhythmias, Cardiac
Infarction
Myocardial Infarction
Cardiomyopathies
Heart Diseases
Cardiovascular Diseases
 Pathologic Processes
Ischemia
Necrosis
Myocardial Ischemia
Vascular Diseases

ClinicalTrials.gov processed this record on May 22, 2013