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

Sponsor

Medtronic Cardiac Rhythm and Heart Failure (Industry)

Overall Status

Completed

CT.gov ID

NCT00305240

Collaborator

Medtronic (Industry)

656

Enrollment

Locations

Duration (Months)

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Myocardial Infarction Arrhythmia, Ventricular Ischemic Cardiomyopathy	Procedure: T Wave Alternans Test	N/A

Study Design

Study Type:

Interventional

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Study Start Date :

Oct 1, 2003

Actual Primary Completion Date :

Feb 1, 2007

Actual Study Completion Date :

Feb 1, 2007

Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts 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)

Contacts and Locations

Locations

	City	State	Country
1	Mobile	Alabama	United States
2	Phoenix	Arizona	United States
3	Walnut Creek	California	United States
4	Denver	Colorado	United States
5	Hartford	Connecticut	United States
6	Hollywood	Florida	United States
7	Naples	Florida	United States
8	Safety Harbor	Florida	United States
9	Atlanta	Georgia	United States
10	Joliet	Illinois	United States
11	Springfield	Illinois	United States
12	Beech Grove	Indiana	United States
13	Kansas City	Kansas	United States
14	New Orleans	Louisiana	United States
15	Hyannis	Massachusetts	United States
16	Grand Rapids	Michigan	United States
17	Saginaw	Michigan	United States
18	St. Joseph	Michigan	United States
19	Minneapolis	Minnesota	United States
20	Omaha	Nebraska	United States
21	Las Vegas	Nevada	United States
22	East Islip	New York	United States
23	Flushing	New York	United States
24	West Islip	New York	United States
25	Gastonia	North Carolina	United States
26	Greensboro	North Carolina	United States
27	High Point	North Carolina	United States
28	Raleigh	North Carolina	United States
29	Cincinnati	Ohio	United States
30	Cleveland	Ohio	United States
31	Columbus	Ohio	United States
32	Toledo	Ohio	United States
33	Doylestown	Pennsylvania	United States
34	Philadelphia	Pennsylvania	United States
35	Pittsburgh	Pennsylvania	United States
36	Scranton	Pennsylvania	United States
37	Spartanburg	South Carolina	United States
38	Chattanooga	Tennessee	United States
39	Germantown	Tennessee	United States
40	Amarillo	Texas	United States
41	Corpus Christi	Texas	United States
42	Plano	Texas	United States
43	Tyler	Texas	United States
44	Burlington	Vermont	United States
45	Chesapeake	Virginia	United States
46	Portsmouth	Virginia	United States
47	Appleton	Wisconsin	United States

Sponsors and Collaborators

Medtronic Cardiac Rhythm and Heart Failure
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