Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

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

This study has been completed.
Information provided by (Responsible Party):
Cambridge Heart Inc. Identifier:
First received: August 2, 2010
Last updated: May 23, 2013
Last verified: May 2013
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).

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

Resource links provided by NLM:

Further study details as provided by Cambridge Heart Inc.:

Enrollment: 186
Study Start Date: June 2010
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
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.

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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01174797

United States, Connecticut
Connecticut Clinical Research, LLC
Bridgeport, Connecticut, United States, 06606
United States, Texas
Northwest Houston Heart Center
Tomball, Texas, United States, 77375
Sponsors and Collaborators
Cambridge Heart Inc.
Principal Investigator: Edward J Kosinski, MD Connecticut Clinical Research, LLC
  More Information

Responsible Party: Cambridge Heart Inc. Identifier: NCT01174797     History of Changes
Other Study ID Numbers: 60-0001-001
Study First Received: August 2, 2010
Last Updated: May 23, 2013

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Pathologic Processes processed this record on April 26, 2017