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

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.

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Key information

Conditions

Myocardial Infarction Arrhythmias Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Infarction Ischemia Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Creighton University Medical Center

Omaha, Nebraska, 68131, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

T-wave Alternans

Procedure

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 outcomes

Evaluate the Diagnostic Accuracy of TWA in Predicting Arrhythmic Events, Cardiovascular Mortality, and Total Mortality in Patients With Acute MI

Time frame: 30 days
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

Sponsors and collaborators

Lead sponsor

Creighton University

Other

Registry information

Important dates

Study start: 2006
Primary completion: 2011
Study completion: 2011
First posted: Jan 10, 2008
Registry last updated: Oct 5, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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