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

Completed

• Conditions: Myocardial Infarction; Arrhythmias

• Registration Number: NCT00589849
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-05
• Study First Submitted: 2007-12-28
• Study First Submitted QC: 2008-01-09
• Study First Posted: 2008-01-10
• Primary Completion: 2011-05
• Study Completion: 2011-05
• Results First Submitted: 2011-08-03
• Status Verified: 2011-09
• Results First Submitted QC: 2011-09-02
• Last Update Submitted: 2011-09-02
• Results First Posted: 2011-10-05
• Last Update Posted: 2011-10-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (1)

Creighton University Medical Center; 🇺🇸 Omaha, Nebraska, United States