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Trial record 15 of 38 for:    alternans

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

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ClinicalTrials.gov Identifier: NCT01174797
Recruitment Status : Completed
First Posted : August 4, 2010
Last Update Posted : May 27, 2013
Sponsor:
Information provided by (Responsible Party):
Cambridge Heart Inc.

Tracking Information
First Submitted Date August 2, 2010
First Posted Date August 4, 2010
Last Update Posted Date May 27, 2013
Study Start Date June 2010
Actual Primary Completion Date May 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History Complete list of historical versions of study NCT01174797 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Evaluation of Microvolt T-Wave Alternans(MTWA) Testing for the Detection of Active Ischemia
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
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).
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
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Coronary Artery Disease
Intervention Not Provided
Study 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: May 23, 2013)
186
Original Estimated Enrollment
 (submitted: August 3, 2010)
200
Actual Study Completion Date May 2013
Actual Primary Completion Date May 2013   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01174797
Other Study ID Numbers 60-0001-001
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Cambridge Heart Inc.
Study Sponsor Cambridge Heart Inc.
Collaborators Not Provided
Investigators
Principal Investigator: Edward J Kosinski, MD Connecticut Clinical Research, LLC
PRS Account Cambridge Heart Inc.
Verification Date May 2013