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

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

March 20, 2006

Last Updated Date

February 11, 2008

Start Date ^†

October 2003

Current 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.

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00305240 on ClinicalTrials.gov Archive Site

Current 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

Original 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

Descriptive Information

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)

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

Study Phase

Study Type ^†

Interventional

Study Design ^†

Diagnostic, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study

Condition ^†

Myocardial Infarction
Arrhythmia, Ventricular
Ischemic Cardiomyopathy

Intervention ^†

Procedure: T Wave Alternans Test

Study Arms / Comparison Groups

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.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

656

Completion Date

February 2007

Primary Completion Date

February 2007 (final data collection date for primary outcome measure)

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)

Gender

Both

Ages

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00305240

Responsible Party

Brett Peterson / Sr. Clinical Trial Leader, Medtronic CRDM Core Clinical

Secondary IDs ^††

Study Sponsor ^†

Medtronic Cardiac Rhythm Disease Management

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

Information Provided By

Medtronic Cardiac Rhythm Disease Management

Verification Date

February 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.