Arrhythmias, Myocardial Infarction
Conditions
Keywords
Myocardial Infarction, Arrhythmia, T-wave alternans
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.
Interventions
PROCEDURET-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
Sponsors
Creighton University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| T Wave Altenans Stress Test | 32 |
| Total | 32 |
Baseline characteristics
| Characteristic | T Wave Altenans Stress Test |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 7 Participants |
| Age, Categorical Between 18 and 65 years | 25 Participants |
| Age Continuous | 58 years STANDARD_DEVIATION 13.04 |
| Region of Enrollment United States | 32 participants |
| Sex: Female, Male Female | 11 Participants |
| Sex: Female, Male Male | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 32 |
| serious Total, serious adverse events | 0 / 32 |
Outcome results
Primary
Evaluate the Diagnostic Accuracy of TWA in Predicting Arrhythmic Events, Cardiovascular Mortality, and Total Mortality in Patients With Acute MI
Time frame: 30 days
Primary
Event Free Survival at 1 Year
Survival without ventricular tachycardia/ventricular fibrillation (VT/VF) or sudden cardiac death at 1 year
Time frame: 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| T Wave Altenans Stress Test | Event Free Survival at 1 Year | 32 participants |