Clinical trial NCT00305214: MASTER II - 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 II)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myocardial Infarction
Arrhythmia, Ventricular
Ischemic Cardiomyopathy
Keywords: Myocardial Infarction
Microvolt T Wave Alternans Test
Implantable Cardioverter Defibrillator (ICD)
Ventricular Arrhythmia
Lead sponsor: Medtronic Cardiac Rhythm and Heart Failure
Sponsor class: INDUSTRY
Collaborators: name: Medtronic
First posted: 2006-03-21
Enrollment: 405
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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 positive MTWA test, they will be more 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.


Eligibility criteria: Inclusion Criteria:

* Patients with a history of heart attacks
* LVEF \>0.30 and \<= 0.40 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

Primary outcomes:
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 Positive result.
Secondary outcomes:
measure: Compare occurrence of all ventricular events between both groups
measure: Identify predictors of life threatening ventricular arrhythmias
measure: Calculate occurrence of life threatening ventricular arrhythmias based on last MTWA results
Other outcomes:
Locations:
city: Mobile
country: United States
state: Alabama
city: Phoenix
country: United States
state: Arizona
city: Walnut Creek
country: United States
state: California
city: Denver
country: United States
state: Colorado
city: Hartford
country: United States
state: Connecticut
city: Hollywood
country: United States
state: Florida
city: Naples
country: United States
state: Florida
city: Safety Harbor
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Joliet
country: United States
state: Illinois
city: Springfield
country: United States
state: Illinois
city: Beech Grove
country: United States
state: Indiana
city: Kansas City
country: United States
state: Kansas
city: New Orleans
country: United States
state: Louisiana
city: Hyannis
country: United States
state: Massachusetts
city: Grand Rapids
country: United States
state: Michigan
city: Saginaw
country: United States
state: Michigan
city: St. Joseph
country: United States
state: Michigan
city: Minneapolis
country: United States
state: Minnesota
city: Omaha
country: United States
state: Nebraska
city: Las Vegas
country: United States
state: Nevada
city: East Islip
country: United States
state: New York
city: Flushing
country: United States
state: New York
city: West Islip
country: United States
state: New York
city: Gastonia
country: United States
state: North Carolina
city: Greensboro
country: United States
state: North Carolina
city: High Point
country: United States
state: North Carolina
city: Raleigh
country: United States
state: North Carolina
city: Cincinnati
country: United States
state: Ohio
city: Cleveland
country: United States
state: Ohio
city: Columbus
country: United States
state: Ohio
city: Toledo
country: United States
state: Ohio
city: Doylestown
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Pittsburgh
country: United States
state: Pennsylvania
city: Scranton
country: United States
state: Pennsylvania
city: Spartanburg
country: United States
state: South Carolina
city: Chattanooga
country: United States
state: Tennessee
city: Germantown
country: United States
state: Tennessee
city: Amarillo
country: United States
state: Texas
city: Corpus Christi
country: United States
state: Texas
city: Plano
country: United States
state: Texas
city: Tyler
country: United States
state: Texas
city: Burlington
country: United States
state: Vermont
city: Chesapeake
country: United States
state: Virginia
city: Portsmouth
country: United States
state: Virginia
city: Appleton
country: United States
state: Wisconsin
Study officials:
affiliation: University of Minnesota
name: David G. Benditt, MD
role: STUDY_CHAIR
affiliation: The Lindner Center for Research and Education
name: Theodore Chow, MD
role: STUDY_CHAIR
affiliation: The Lindner Center for Research and Education
name: Dean J. Kereiakes, MD, FACC
role: STUDY_CHAIR
References: