- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01174797
Evaluation of Microvolt T-Wave Alternans(MTWA) Testing for the Detection of Active Ischemia (MTWA-CAD)
May 23, 2013 updated by: Cambridge Heart Inc.
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
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).
Study Overview
Status
Completed
Conditions
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 Type
Observational
Enrollment (Actual)
186
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Connecticut
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Bridgeport, Connecticut, United States, 06606
- Connecticut Clinical Research, Llc
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Texas
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Tomball, Texas, United States, 77375
- Northwest Houston Heart Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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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.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Edward J Kosinski, MD, Connecticut Clinical Research, Llc
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2010
Primary Completion (Actual)
May 1, 2013
Study Completion (Actual)
May 1, 2013
Study Registration Dates
First Submitted
August 2, 2010
First Submitted That Met QC Criteria
August 3, 2010
First Posted (Estimate)
August 4, 2010
Study Record Updates
Last Update Posted (Estimate)
May 27, 2013
Last Update Submitted That Met QC Criteria
May 23, 2013
Last Verified
May 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 60-0001-001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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