Evaluation of Microvolt T-Wave Alternans(MTWA) Testing for the Detection of Active Ischemia

Completed

• Conditions: Coronary Artery Disease

• Registration Number: NCT01174797
• Lead Sponsor: Cambridge Heart Inc.

Brief Summary

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).

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.

Study Timeline

• Study Start: 2010-06
• Study First Submitted: 2010-08-02
• Study First Submitted QC: 2010-08-03
• Study First Posted: 2010-08-04
• Status Verified: 2013-05
• Primary Completion: 2013-05
• Study Completion: 2013-05
• Last Update Submitted: 2013-05-23
• Last Update Posted: 2013-05-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 186

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (2)

Connecticut Clinical Research, LLC; 🇺🇸 Bridgeport, Connecticut, United States

Northwest Houston Heart Center; 🇺🇸 Tomball, Texas, United States