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

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ClinicalTrials.gov Identifier: NCT00589849
Recruitment Status : Completed
First Posted : January 10, 2008
Results First Posted : October 5, 2011
Last Update Posted : October 5, 2011
Sponsor:
Information provided by (Responsible Party):
Creighton University

Brief Summary:
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 or disease Intervention/treatment
Myocardial Infarction Arrhythmias Procedure: T-wave Alternans

Study Type : Observational
Actual Enrollment : 32 participants
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
Study Start Date : May 2006
Actual Primary Completion Date : May 2011
Actual Study Completion Date : May 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack
U.S. FDA Resources

Group/Cohort Intervention/treatment
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



Primary Outcome Measures :
  1. Evaluate the Diagnostic Accuracy of TWA in Predicting Arrhythmic Events, Cardiovascular Mortality, and Total Mortality in Patients With Acute MI [ Time Frame: 30 days ]
  2. Event Free Survival at 1 Year [ Time Frame: 12 months ]
    Survival without ventricular tachycardia/ventricular fibrillation (VT/VF) or sudden cardiac death at 1 year



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Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Creighton University
ClinicalTrials.gov Identifier: NCT00589849     History of Changes
Other Study ID Numbers: 05-13651
05-13651
First Posted: January 10, 2008    Key Record Dates
Results First Posted: October 5, 2011
Last Update Posted: October 5, 2011
Last Verified: September 2011

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

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