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

Purpose

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	Intervention
Myocardial Infarction Arrhythmia, Ventricular Ischemic Cardiomyopathy	Procedure: T Wave Alternans Test


Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic
Official Title:	Microvolt T Wave Alternans Testing for Risk Stratification of Post MI Patients (MASTER I)

Resource links provided by NLM:

MedlinePlus related topics: Heart Attack

U.S. FDA Resources

Further study details as provided by Medtronic Cardiac Rhythm and Heart Failure:

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


Estimated Enrollment:	656
Study Start Date:	October 2003
Study Completion Date:	February 2007
Primary Completion Date:	February 2007 (Final data collection date for primary outcome measure)

Eligibility


Ages Eligible for Study:	Child, Adult, Senior
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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)

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00305240

Show 47 Study Locations

Sponsors and Collaborators

Medtronic Cardiac Rhythm and Heart Failure

Medtronic

Investigators


Study Chair:	David G. Benditt, MD	University of Minnesota - Clinical and Translational Science Institute
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

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.


Responsible Party:	Brett Peterson / Sr. Clinical Trial Leader, Medtronic CRDM Core Clinical
ClinicalTrials.gov Identifier:	NCT00305240 History of Changes
Other Study ID Numbers:	220a
Study First Received:	March 20, 2006
Last Updated:	February 11, 2008
Health Authority:	United States: Institutional Review Board

Keywords provided by Medtronic Cardiac Rhythm and Heart Failure:


Myocardial Infarction Microvolt T Wave Alternans Test Implantable Cardioverter Defibrillator (ICD) Ventricular Arrythmias

Additional relevant MeSH terms:


Infarction Myocardial Infarction Cardiomyopathies Ischemia Pathologic Processes	Necrosis Myocardial Ischemia Heart Diseases Cardiovascular Diseases Vascular Diseases

ClinicalTrials.gov processed this record on September 27, 2016