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

Sponsor

Cambridge Heart Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT01174797

Collaborator

(none)

186

Enrollment

Locations

Duration (Months)

Patients Per Site

2.7

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease

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.

Study Design

Study Type:

Observational

Actual Enrollment :

186 participants

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

Study Start Date :

Jun 1, 2010

Actual Primary Completion Date :

May 1, 2013

Actual Study Completion Date :

May 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Connecticut Clinical Research, LLC	Bridgeport	Connecticut	United States	06606
2	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Cambridge Heart Inc.

ClinicalTrials.gov Identifier:

NCT01174797

Other Study ID Numbers:

60-0001-001

First Posted:

Aug 4, 2010

Last Update Posted:

May 27, 2013

Last Verified:

May 1, 2013

Additional relevant MeSH terms:

Coronary Artery Disease

Myocardial Ischemia

Coronary Disease

Ischemia

Study Results

No Results Posted as of May 27, 2013