T-Wave Alternans in Acute Myocardial Infarction: An Evaluation of the Time of Testing on Its Prognostic Accuracy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Creighton University
ClinicalTrials.gov Identifier:
NCT00589849
First received: December 28, 2007
Last updated: September 2, 2011
Last verified: September 2011
  Purpose

T-wave alternans is an electrocardiographic finding that has been shown to predict the occurrence of future cardiac arrhythmias in patients who have had a heart attack. What is unknown about T-wave alternans testing is when is the best time to perform the test. In most studies, T-wave alternans testing is conducted 4 weeks or more after a heart attack. It is unknown if T-wave alternans testing performed prior to hospital discharge in heart attack patients is reliable. The objective of this project is to determine the diagnostic accuracy of T-wave alternans testing performed prior to hospital discharge and again at 30 days after hospital discharge in patients who have suffered a heart attack.


Condition Intervention
Myocardial Infarction
Arrhythmias
Procedure: T-wave Alternans

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: T-Wave Alternans in Acute Myocardial Infarction: An Evaluation of the Time of Testing on Its Prognostic Accuracy

Resource links provided by NLM:


Further study details as provided by Creighton University:

Primary Outcome Measures:
  • Evaluate the Diagnostic Accuracy of TWA in Predicting Arrhythmic Events, Cardiovascular Mortality, and Total Mortality in Patients With Acute MI [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Event Free Survival at 1 Year [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Survival without ventricular tachycardia/ventricular fibrillation (VT/VF) or sudden cardiac death at 1 year


Enrollment: 32
Study Start Date: May 2006
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1 Procedure: T-wave Alternans
T-wave alternans is an electrocardiographic finding that is defined as the beat-to beat fluctuation in the amplitude or shape of T wave

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Hospitalized patients

Criteria

Inclusion Criteria:

  • Acute Myocardial Infarction (MI) confirmed by electrocardiographic and or/ enzymatic criteria
  • Patients with a left ventricular ejection fraction of 45% or less

Exclusion Criteria:

  • Patients with (1) atrial fibrillation, (2) pacemaker rhythm, (3) left bundle branch block, (4) class III-IV heart failure, (5) inability to achieve a target heart rate with exercise or handgrip stress or (6) spontaneous sustained ventricular tachycardia/ventricular fibrillation will be excluded
  • Patients with recurrent angina pectoris, MI, coronary revascularization, or any other adverse cardiovascular event in the 30 days following their initial MI will also be excluded
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00589849

Locations
United States, Nebraska
Creighton University Medical Center
Omaha, Nebraska, United States, 68131
Sponsors and Collaborators
Creighton University
Investigators
Principal Investigator: Aryan Mooss, MD Creighton University
  More Information

No publications provided

Responsible Party: Creighton University
ClinicalTrials.gov Identifier: NCT00589849     History of Changes
Other Study ID Numbers: 05-13651, 05-13651
Study First Received: December 28, 2007
Results First Received: August 3, 2011
Last Updated: September 2, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Creighton University:
Myocardial Infarction
Arrhythmia
T-wave alternans

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Cardiovascular Diseases
Heart Diseases
Ischemia
Myocardial Ischemia
Necrosis
Pathologic Processes
Vascular Diseases

ClinicalTrials.gov processed this record on October 29, 2014