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Completed

NCT Number: NCT00305240

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

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.

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Key information

Conditions

Myocardial Infarction Arrhythmia, Ventricular Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Infarction Ischemia Ischemic Cardiomyopathy Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mobile, Alabama, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

T Wave Alternans Test

Procedure

Primary outcomes

  1. 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 outcomes

  1. Compare occurrence of all ventricular events between both groups

  2. Identify predictors of life threatening ventricular arrhythmias

  3. Calculate occurrence of life threatening ventricular arrhythmias based on last MTWA results

Sponsors and collaborators

Lead sponsor

Medtronic Cardiac Rhythm and Heart Failure

Industry

Collaborators

  • Medtronic

Registry information

Official study title

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

Important dates

Study start
2003
Primary completion
2007
Study completion
2007
First posted
Mar 21, 2006
Registry last updated
Feb 13, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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