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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
History of Changes
  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:

U.S. FDA Resources

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
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:
Arrhythmias, Cardiac
Infarction
Myocardial Infarction
Heart Diseases
Cardiovascular Diseases
 Pathologic Processes
Ischemia
Necrosis
Myocardial Ischemia
Vascular Diseases

ClinicalTrials.gov processed this record on May 22, 2013