Intracardiac T-wave Alternans and Ischemia

This study has been completed.
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
Jose M. Dizon, Columbia University
ClinicalTrials.gov Identifier:
NCT00669552
First received: April 28, 2008
Last updated: April 11, 2013
Last verified: April 2013
  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 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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: April 28, 2008
Results First Received: February 15, 2013
Last Updated: April 11, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Ischemia
Pathologic Processes

ClinicalTrials.gov processed this record on September 18, 2014