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

11. februar 2008 opdateret af: Medtronic Cardiac Rhythm and Heart Failure

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

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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Procedure: T Wave Alternans Test

Undersøgelsestype

Interventionel

Tilmelding

405

Fase

Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

Forenede Stater
- Alabama
  - Mobile, Alabama, Forenede Stater
- Arizona
  - Phoenix, Arizona, Forenede Stater
- California
  - Walnut Creek, California, Forenede Stater
- Colorado
  - Denver, Colorado, Forenede Stater
- Connecticut
  - Hartford, Connecticut, Forenede Stater
- Florida
  - Hollywood, Florida, Forenede Stater
  - Naples, Florida, Forenede Stater
  - Safety Harbor, Florida, Forenede Stater
- Georgia
  - Atlanta, Georgia, Forenede Stater
- Illinois
  - Joliet, Illinois, Forenede Stater
  - Springfield, Illinois, Forenede Stater
- Indiana
  - Beech Grove, Indiana, Forenede Stater
- Kansas
  - Kansas City, Kansas, Forenede Stater
- Louisiana
  - New Orleans, Louisiana, Forenede Stater
- Massachusetts
  - Hyannis, Massachusetts, Forenede Stater
- Michigan
  - Grand Rapids, Michigan, Forenede Stater
  - Saginaw, Michigan, Forenede Stater
  - St. Joseph, Michigan, Forenede Stater
- Minnesota
  - Minneapolis, Minnesota, Forenede Stater
- Nebraska
  - Omaha, Nebraska, Forenede Stater
- Nevada
  - Las Vegas, Nevada, Forenede Stater
- New York
  - East Islip, New York, Forenede Stater
  - Flushing, New York, Forenede Stater
  - West Islip, New York, Forenede Stater
- North Carolina
  - Gastonia, North Carolina, Forenede Stater
  - Greensboro, North Carolina, Forenede Stater
  - High Point, North Carolina, Forenede Stater
  - Raleigh, North Carolina, Forenede Stater
- Ohio
  - Cincinnati, Ohio, Forenede Stater
  - Cleveland, Ohio, Forenede Stater
  - Columbus, Ohio, Forenede Stater
  - Toledo, Ohio, Forenede Stater
- Pennsylvania
  - Doylestown, Pennsylvania, Forenede Stater
  - Philadelphia, Pennsylvania, Forenede Stater
  - Pittsburgh, Pennsylvania, Forenede Stater
  - Scranton, Pennsylvania, Forenede Stater
- South Carolina
  - Spartanburg, South Carolina, Forenede Stater
- Tennessee
  - Chattanooga, Tennessee, Forenede Stater
  - Germantown, Tennessee, Forenede Stater
- Texas
  - Amarillo, Texas, Forenede Stater
  - Corpus Christi, Texas, Forenede Stater
  - Plano, Texas, Forenede Stater
  - Tyler, Texas, Forenede Stater
- Vermont
  - Burlington, Vermont, Forenede Stater
- Virginia
  - Chesapeake, Virginia, Forenede Stater
  - Portsmouth, Virginia, Forenede Stater
- Wisconsin
  - Appleton, Wisconsin, Forenede Stater

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

Barn
Voksen
Ældre voksen

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Primært formål: Diagnostisk
Tildeling: Ikke-randomiseret
Interventionel model: Enkelt gruppeopgave
Maskning: Ingen (Åben etiket)

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
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.

Sekundære resultatmål

Resultatmål
Sammenlign forekomsten af alle ventrikulære hændelser mellem begge grupper
Identificer prædiktorer for livstruende ventrikulære arytmier
Beregn forekomsten af livstruende ventrikulære arytmier baseret på sidste MTWA-resultater

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Medtronic Cardiac Rhythm and Heart Failure

Samarbejdspartnere

Medtronic

Efterforskere

Studiestol: David G. Benditt, MD, University of Minnesota
Studiestol: Theodore Chow, MD, The Lindner Center for Research and Education
Studiestol: Dean J. Kereiakes, MD, FACC, The Lindner Center for Research and Education

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. oktober 2003

Primær færdiggørelse (Faktiske)

1. februar 2007

Studieafslutning (Faktiske)