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Completed

NCT Number: NCT01174797

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

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Connecticut Clinical Research, LLC, Bridgeport, Connecticut, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Sponsors and collaborators

Lead sponsor

Cambridge Heart Inc.

Industry

Registry information

Official study 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

Acronym: MTWA-CAD

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Aug 4, 2010
Registry last updated
May 27, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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