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

April 28, 2008
April 11, 2013
August 2008
July 2012   (final data collection date for primary outcome measure)
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.
Not Provided
Complete list of historical versions of study NCT00669552 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Intracardiac T-wave Alternans and Ischemia
Intracardiac T-wave Alternans and Ischemia During Percutaneous Coronary Interventions

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Patients with coronary artery disease (CAD) undergoing PCI that also have an appropriate Medtronic implantable defibrillator.

Ischemia
Procedure: Percutaneous coronary intervention
PCI previously electively scheduled.
Medtronic defibrillator
Patients undergoing a percutaneous coronary intervention (PCI) with an implanted Medtronic defibrillator with the capability of telemetry of the intracardiac signal.
Intervention: Procedure: Percutaneous coronary intervention
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
11
July 2012
July 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • non-elective procedure
  • non-qualifying defibrillator type.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00669552
AAAC6715
No
Jose M. Dizon, Columbia University
Columbia University
Medtronic
Principal Investigator: Jose M Dizon, MD Columbia University
Columbia University
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP