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

Myocardial Infarction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00305240
• Other study ID #: 220a
• Status: Completed
• Phase: N/A
• First received: March 20, 2006
• Last updated: February 11, 2008
• Start date: October 2003
• Est. completion date: February 2007

Study information

• Verified date: February 2008
• Source: Medtronic Cardiac Rhythm Disease Management
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 656
• Est. completion date: February 2007
• Est. primary completion date: February 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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)

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Arrhythmia, Ventricular
• Cardiomyopathies
• Infarction
• Ischemic Cardiomyopathy
• Myocardial Infarction

Intervention

Procedure:
• T Wave Alternans Test

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Medtronic Cardiac Rhythm Disease Management	Medtronic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Compare occurrence of all ventricular events between both groups
Secondary	Identify predictors of life threatening ventricular arrhythmias
Secondary	Calculate occurrence of life threatening ventricular arrhythmias based on last MTWA results