MASTER I - 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 I)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

656

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

  • United States
    • Alabama
      • Mobile, Alabama, United States
    • Arizona
      • Phoenix, Arizona, United States
    • California
      • Walnut Creek, California, United States
    • Colorado
      • Denver, Colorado, United States
    • Connecticut
      • Hartford, Connecticut, United States
    • Florida
      • Hollywood, Florida, United States
      • Naples, Florida, United States
      • Safety Harbor, Florida, United States
    • Georgia
      • Atlanta, Georgia, United States
    • Illinois
      • Joliet, Illinois, United States
      • Springfield, Illinois, United States
    • Indiana
      • Beech Grove, Indiana, United States
    • Kansas
      • Kansas City, Kansas, United States
    • Louisiana
      • New Orleans, Louisiana, United States
    • Massachusetts
      • Hyannis, Massachusetts, United States
    • Michigan
      • Grand Rapids, Michigan, United States
      • Saginaw, Michigan, United States
      • St. Joseph, Michigan, United States
    • Minnesota
      • Minneapolis, Minnesota, United States
    • Nebraska
      • Omaha, Nebraska, United States
    • Nevada
      • Las Vegas, Nevada, United States
    • New York
      • East Islip, New York, United States
      • Flushing, New York, United States
      • West Islip, New York, 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
    • Ohio
      • Cincinnati, Ohio, United States
      • Cleveland, Ohio, United States
      • Columbus, Ohio, United States
      • Toledo, Ohio, United States
    • Pennsylvania
      • Doylestown, Pennsylvania, United States
      • Philadelphia, Pennsylvania, United States
      • Pittsburgh, Pennsylvania, United States
      • Scranton, Pennsylvania, United States
    • South Carolina
      • Spartanburg, South Carolina, United States
    • Tennessee
      • Chattanooga, Tennessee, United States
      • Germantown, Tennessee, United States
    • Texas
      • Amarillo, Texas, United States
      • Corpus Christi, Texas, United States
      • Plano, Texas, United States
      • Tyler, Texas, United States
    • Vermont
      • Burlington, Vermont, United States
    • Virginia
      • Chesapeake, Virginia, United States
      • Portsmouth, Virginia, United States
    • Wisconsin
      • Appleton, Wisconsin, United States

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 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)

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
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

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medtronic Cardiac Rhythm and Heart Failure

Collaborators

Medtronic

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

  • 220a

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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