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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Cambridge Heart Inc.
ClinicalTrials.gov Identifier:
NCT01174797
First received: August 2, 2010
Last updated: May 23, 2013
Last verified: May 2013
  Purpose

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).


Condition
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

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)
Groups/Cohorts
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.

Criteria

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 ClinicalTrials.gov identifier: NCT01174797

Locations
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.
Investigators
Principal Investigator: Edward J Kosinski, MD Connecticut Clinical Research, LLC
  More Information

No publications provided

Responsible Party: Cambridge Heart Inc.
ClinicalTrials.gov Identifier: NCT01174797     History of Changes
Other Study ID Numbers: 60-0001-001
Study First Received: August 2, 2010
Last Updated: May 23, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on September 18, 2014