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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

Tracking Information
First Submitted Date  ICMJE March 20, 2006
First Posted Date  ICMJE March 21, 2006
Last Update Posted Date February 13, 2008
Study Start Date  ICMJE October 2003
Actual Primary Completion Date February 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 20, 2006)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 20, 2006)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE MASTER I - Microvolt T Wave Alternans Testing for Risk Stratification of Post MI Patients
Official Title  ICMJE Microvolt T Wave Alternans Testing for Risk Stratification of Post MI Patients (MASTER I)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Myocardial Infarction
  • Arrhythmia, Ventricular
  • Ischemic Cardiomyopathy
Intervention  ICMJE Procedure: T Wave Alternans Test
Study Arms  ICMJE Not Provided
Publications * Chow T, Kereiakes DJ, Onufer J, Woelfel A, Gursoy S, Peterson BJ, Brown ML, Pu W, Benditt DG; MASTER Trial Investigators. Does microvolt T-wave alternans testing predict ventricular tachyarrhythmias in patients with ischemic cardiomyopathy and prophylactic defibrillators? The MASTER (Microvolt T Wave Alternans Testing for Risk Stratification of Post-Myocardial Infarction Patients) trial. J Am Coll Cardiol. 2008 Nov 11;52(20):1607-15. doi: 10.1016/j.jacc.2008.08.018.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: March 20, 2006)
656
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2007
Actual Primary Completion Date February 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00305240
Other Study ID Numbers  ICMJE 220a
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Brett Peterson / Sr. Clinical Trial Leader, Medtronic CRDM Core Clinical
Study Sponsor  ICMJE Medtronic Cardiac Rhythm and Heart Failure
Collaborators  ICMJE Medtronic
Investigators  ICMJE
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
PRS Account Medtronic Cardiac Rhythm and Heart Failure
Verification Date February 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP