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Intracardiac T-wave Alternans and Ischemia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00669552
First Posted: April 30, 2008
Last Update Posted: April 19, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Medtronic
Information provided by (Responsible Party):
Jose M. Dizon, Columbia University
  Purpose

T-wave alternans is a test that looks at microvolt changes in the T-wave on a beat to beat basis. The presence or absence of such changes has been shown to predict or exclude future arrhythmic events. The mechanism of T-wave alternans is unclear, but may relate to calcium metabolism in the heart, and may be affected by conditions such as ischemia or heart failure.

The purpose of this study is to determine whether T-wave alternans, as measured through the lead of an implantable defibrillator, is produced by acute ischemia induced by occlusion during percutaneous coronary interventions.


Condition Intervention
Ischemia Procedure: Percutaneous coronary intervention

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Intracardiac T-wave Alternans and Ischemia During Percutaneous Coronary Interventions

Further study details as provided by Jose M. Dizon, Columbia University:

Primary Outcome Measures:
  • Number of Subjects With Positive T Wave Studies During a Coronary Intervention [ Time Frame: During the coronary intervention, upto 2 hours ]
    Positive T wave alternans is determined by a proprietary program using ECG recordings during a stress test. The result is reported as positive, negative, or indeterminate.


Enrollment: 11
Study Start Date: August 2008
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Medtronic defibrillator
Patients undergoing a percutaneous coronary intervention (PCI) with an implanted Medtronic defibrillator with the capability of telemetry of the intracardiac signal.
Procedure: Percutaneous coronary intervention
PCI previously electively scheduled.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with coronary artery disease (CAD) undergoing PCI that also have an appropriate Medtronic implantable defibrillator.
Criteria

Inclusion Criteria:

  • patient with CAD undergoing PCI with appropriate Medtronic implantable defibrillator.

Exclusion Criteria:

  • non-elective procedure
  • non-qualifying defibrillator type.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00669552


Locations
United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
Sponsors and Collaborators
Columbia University
Medtronic
Investigators
Principal Investigator: Jose M Dizon, MD Columbia University
  More Information

Responsible Party: Jose M. Dizon, Assoc Professor of Clinical, Department of Medicine Cardiology, Columbia University
ClinicalTrials.gov Identifier: NCT00669552     History of Changes
Other Study ID Numbers: AAAC6715
First Submitted: April 28, 2008
First Posted: April 30, 2008
Results First Submitted: February 15, 2013
Results First Posted: March 28, 2013
Last Update Posted: April 19, 2013
Last Verified: April 2013

Additional relevant MeSH terms:
Ischemia
Pathologic Processes