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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01174797

Acronym

MTWA-CAD

Enrollment

186

Registered

2010-08-04

Start date

2010-06-30

Completion date

2013-05-31

Last updated

2013-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Countries

United States

Outcome results