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

NCT01174797 | Completed

• 1 other identifier: 60-0001-001
• Study Type: observational
• Target: 186
• Locations: 1 country
• Sites: 2

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).

Conditions

Coronary Artery Disease

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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 & Collaborators

• Cambridge Heart Inc.: lead

Study Sites (2)

Connecticut Clinical Research, LLC

Bridgeport, Connecticut, 06606, United States

Location

Northwest Houston Heart Center

Tomball, Texas, 77375, United States

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Edward J Kosinski, MD

  Connecticut Clinical Research, LLC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2010
• First Posted: August 4, 2010
• Study Start: June 1, 2010
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: May 27, 2013

Record last verified: 2013-05

Locations

US (2)