Evaluation of Microvolt T-Wave Alternans(MTWA) Testing for the Detection of Active Ischemia
Status: | Recruiting |
---|---|
Conditions: | Peripheral Vascular Disease, Cardiology |
Therapuetic Areas: | Cardiology / Vascular Diseases |
Healthy: | No |
Age Range: | Any |
Updated: | 11/18/2012 |
Start Date: | June 2010 |
Evaluation of Microvolt T-Wave Alternans Testing for the Detection of Active Ischemia in Patients With Known or Suspected Coronary Artery Disease: A Feasibility Study
MTWA-CAD is a feasibility study designed to evaluate Microvolt T-Wave Alternans (MTWA)
testing for the purpose of detecting active ischemia in patients with known or suspected
coronary artery disease (CAD). MTWA is a subtle, alternating pattern in the T wave portion
of the surface electrocardiogram (ECG) that is associated with increased risk of ventricular
tachyarrhythmias and sudden cardiac arrest (SCA).
Ischemia, a common trigger for arrhythmias, is a well-documented cause of repolarization
alternans. Human studies have shown that active ischemia can be associated with visible as
well as microvolt-level T-wave alternans. While MTWA testing is traditionally used to
evaluate arrhythmic risk, this known association with ischemia may allow MTWA testing to be
used as a diagnostic tool to detect underlying CAD. The MTWA-CAD study will assess the
feasibility of this concept by measuring MTWA during routine nuclear stress testing or
stress echocardiography with treadmill exercise. This is a feasibility study designed to
verify preliminary observations under controlled environments and to generate hypotheses,
endpoints, and sample sizes for future investigations.
Inclusion Criteria:
- Age 18 or above, or of legal age to give informed consent specific to state and
national law
- Willing and capable of providing informed consent
- Willing and capable of undergoing a SPECT MPI exercise test (or stress echo) at an
approved clinical investigational center
- In normal sinus rhythm at the time of the exercise test
- A life expectancy of more than 6 months
Exclusion Criteria:
- In atrial fibrillation at the time of the exercise test
- Left bundle branch block (precludes ST segment measurement)
- Pacemaker-dependent
- Life expectancy of less than 6 months
- Pregnancy
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