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

Primary Purpose

Myocardial Infarction, Arrhythmia, Ventricular, Ischemic Cardiomyopathy

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
T Wave Alternans Test
Sponsored by
Medtronic Cardiac Rhythm and Heart Failure
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Myocardial Infarction focused on measuring Myocardial Infarction, Microvolt T Wave Alternans Test, Implantable Cardioverter Defibrillator (ICD), Ventricular Arrythmias

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

Outcomes

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

Full Information

First Posted
March 20, 2006
Last Updated
February 11, 2008
Sponsor
Medtronic Cardiac Rhythm and Heart Failure
Collaborators
Medtronic
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1. Study Identification

Unique Protocol Identification Number
NCT00305240
Brief Title
MASTER I - Microvolt T Wave Alternans Testing for Risk Stratification of Post MI Patients
Official Title
Microvolt T Wave Alternans Testing for Risk Stratification of Post MI Patients (MASTER I)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2008
Overall Recruitment Status
Completed
Study Start Date
October 2003 (undefined)
Primary Completion Date
February 2007 (Actual)
Study Completion Date
February 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Medtronic Cardiac Rhythm and Heart Failure
Collaborators
Medtronic

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction, Arrhythmia, Ventricular, Ischemic Cardiomyopathy
Keywords
Myocardial Infarction, Microvolt T Wave Alternans Test, Implantable Cardioverter Defibrillator (ICD), Ventricular Arrythmias

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
656 (false)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
T Wave Alternans Test
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Compare occurrence of all ventricular events between both groups
Title
Identify predictors of life threatening ventricular arrhythmias
Title
Calculate occurrence of life threatening ventricular arrhythmias based on last MTWA results

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David G. Benditt, MD
Organizational Affiliation
University of Minnesota
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Theodore Chow, MD
Organizational Affiliation
The Lindner Center for Research and Education
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Dean J Kereiakes, MD, FACC
Organizational Affiliation
The Lindner Center for Research and Education
Official's Role
Study Chair
Facility Information:
City
Mobile
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United States
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Phoenix
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Walnut Creek
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Denver
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Hartford
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Hollywood
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Naples
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Safety Harbor
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Atlanta
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Joliet
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Springfield
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Beech Grove
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New Orleans
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Grand Rapids
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Saginaw
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St. Joseph
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Minneapolis
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Omaha
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Las Vegas
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East Islip
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Flushing
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West Islip
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Gastonia
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Greensboro
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High Point
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Raleigh
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Cincinnati
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Cleveland
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Columbus
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Toledo
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Doylestown
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Philadelphia
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Pittsburgh
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Scranton
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Spartanburg
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South Carolina
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Chattanooga
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Germantown
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Amarillo
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Corpus Christi
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Plano
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Tyler
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Burlington
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Vermont
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Chesapeake
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Portsmouth
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Appleton
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Wisconsin
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United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
18992649
Citation
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.
Results Reference
derived

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

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