Evaluation of Microvolt T-Wave Alternans(MTWA) Testing for the Detection of Active Ischemia (MTWA-CAD)
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Purpose
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).
| Condition |
|---|
|
Coronary Artery Disease |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Retrospective |
| Official Title: | 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 |
| Estimated Enrollment: | 200 |
| Study Start Date: | June 2010 |
| Groups/Cohorts |
|---|
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Patients being evaluated for active ischemia
Subjects with known or suspected CAD who are scheduled to undergo routine exercise MPI or stress echocardiography for the detection of active ischemia are eligible for enrollment.
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Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Subjects with known or suspected CAD who are scheduled to undergo routine exercise MPI or stress echocardiography testing for the detection of active ischemia in a cardiology practice or hospital setting.
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
Contacts and Locations| United States, Connecticut | |
| Connecticut Clinical Research, LLC | |
| Bridgeport, Connecticut, United States, 06606 | |
| United States, Texas | |
| Northwest Houston Heart Center | |
| Tomball, Texas, United States, 77375 | |
| Principal Investigator: | Edward J Kosinski, MD | Connecticut Clinical Research, LLC |
More Information
No publications provided
| Responsible Party: | Cambridge Heart Inc. |
| ClinicalTrials.gov Identifier: | NCT01174797 History of Changes |
| Other Study ID Numbers: | 60-0001-001 |
| Study First Received: | August 2, 2010 |
| Last Updated: | November 28, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Coronary Artery Disease Myocardial Ischemia Coronary Disease Ischemia Heart Diseases |
Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Pathologic Processes |
ClinicalTrials.gov processed this record on May 16, 2013