N/A
N=32
T-Wave Alternans in Acute Myocardial Infarction: An Evaluation of the Time of Testing on Its Prognostic Accuracy
Myocardial Infarction · Arrhythmias
Bottom Line
View on ClinicalTrials.gov: NCT00589849 ↗Enrolled (actual)
32
Serious AEs
0.0%
Results posted
Oct 2011
Primary outcome: Primary: Evaluate the Diagnostic Accuracy of TWA in Predicting Arrhythmic Events, Cardiovascular Mortality, and Total Mortality in Patients With Acute MI
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- T-wave Alternans (Procedure)
- Age
- Adult, Older Adult · 19+ yrs
- Sex
- All
- Sponsor
- Creighton University
- Primary completion
- May 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Evaluate the Diagnostic Accuracy of TWA in Predicting Arrhythmic Events, Cardiovascular Mortality, and Total Mortality in Patients With Acute MI |
— | — |
| PRIMARY Event Free Survival at 1 Year |
32 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00589849). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.