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

Coronary Artery Disease Clinical Trial

— MTWA-CAD  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01174797
• Other study ID #: 60-0001-001
• Status: Completed
• Phase: N/A
• First received: August 2, 2010
• Last updated: May 23, 2013
• Start date: June 2010
• Est. completion date: May 2013

Study information

• Verified date: May 2013
• Source: Cambridge Heart Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 186
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Locations

Country	Name	City	State
United States	Connecticut Clinical Research, LLC	Bridgeport	Connecticut
United States	Northwest Houston Heart Center	Tomball	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Cambridge Heart Inc.

Country where clinical trial is conducted

United States,