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Myocardial InfarctionNCT00305240

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

A study testing T Wave Alternans Test in people with Myocardial Infarction and Arrhythmia, Ventricular, run by Medtronic Cardiac Rhythm and Heart Failure at 47 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Any age
What is being tested?
T Wave Alternans Test
Type of treatment
Surgery or procedure
How many people
656 participants
Where
47 sitesUnited States
Study dates
Oct 2003to Feb 2007
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 13Show fewer
  • 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)

Trial locations and contacts

47 sites in 1 country.

47 sites in 1 country

United States47 sites

  • Study site

    Amarillo, Texas

  • Study site

    Appleton, Wisconsin

  • Study site

    Atlanta, Georgia

  • Study site

    Beech Grove, Indiana

  • Study site

    Burlington, Vermont

  • Study site

    Chattanooga, Tennessee

  • Study site

    Chesapeake, Virginia

  • Study site

    Cincinnati, Ohio

  • Study site

    Cleveland, Ohio

  • Study site

    Columbus, Ohio

  • Study site

    Corpus Christi, Texas

  • Study site

    Denver, Colorado

  • Study site

    Doylestown, Pennsylvania

  • Study site

    East Islip, New York

  • Study site

    Flushing, New York

  • Study site

    Gastonia, North Carolina

  • Study site

    Germantown, Tennessee

  • Study site

    Grand Rapids, Michigan

  • Study site

    Greensboro, North Carolina

  • Study site

    Hartford, Connecticut

  • Study site

    High Point, North Carolina

  • Study site

    Hollywood, Florida

  • Study site

    Hyannis, Massachusetts

  • Study site

    Joliet, Illinois

  • Study site

    Kansas City, Kansas

  • Study site

    Las Vegas, Nevada

  • Study site

    Minneapolis, Minnesota

  • Study site

    Mobile, Alabama

  • Study site

    Naples, Florida

  • Study site

    New Orleans, Louisiana

  • Study site

    Omaha, Nebraska

  • Study site

    Philadelphia, Pennsylvania

  • Study site

    Phoenix, Arizona

  • Study site

    Pittsburgh, Pennsylvania

  • Study site

    Plano, Texas

  • Study site

    Portsmouth, Virginia

  • Study site

    Raleigh, North Carolina

  • Study site

    Safety Harbor, Florida

  • Study site

    Saginaw, Michigan

  • Study site

    Saint Joseph, Michigan

  • Study site

    Scranton, Pennsylvania

  • Study site

    Spartanburg, South Carolina

  • Study site

    Springfield, Illinois

  • Study site

    Toledo, Ohio

  • Study site

    Tyler, Texas

  • Study site

    Walnut Creek, California

  • Study site

    West Islip, New York

Other trials in United States

About this study

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

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.

Being tested
T Wave Alternans Test
Keywords
Myocardial Infarction, Microvolt T Wave Alternans Test, Implantable Cardioverter Defibrillator (ICD), Ventricular Arrythmias
Medical subject headings
Myocardial Infarction, Arrhythmias, Cardiac

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • T Wave Alternans TestProcedure or surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  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 (3)

  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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Mar 2006 (estimated)
  2. Study startOct 2003
  3. Primary completionFeb 2007
  4. Study completionFeb 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
656 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00305240
Sponsor's protocol ID
220a
Status last verified
Feb 2008
First submitted
20 Mar 2006
Last updated
13 Feb 2008
Results posted
No

Publications

  • 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.

    PubMed 18992649

Questions about this trial

What is this clinical trial studying?

A study testing T Wave Alternans Test in people with Myocardial Infarction and Arrhythmia, Ventricular, run by Medtronic Cardiac Rhythm and Heart Failure at 47 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Feb 2008. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 47 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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 Non-Negative (Positive or Indeterminate) result.. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00305240, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2008.

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