Intracardiac T-Wave Alternans and Ischemia - Full Text View

Sponsors and Collaborators:	Columbia University Medtronic
Information provided by:	Columbia University
ClinicalTrials.gov Identifier:	NCT00669552

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

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	Intracardiac T-Wave Alternans and Ischemia During Percutaneous Coronary Interventions

Further study details as provided by Columbia University:

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	20
Study Start Date:	May 2008
Estimated Study Completion Date:	June 2009
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
A Patients undergoing a percutaneous coronary intervention 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 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00669552

Contacts

Contact: Jose' M Dizon, MD

212-305-8559

jmd11@columbia.edu

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:	Columbia University ( Jose' M. Dizon, MD )
Study ID Numbers:	AAAC6715
Study First Received:	April 28, 2008
Last Updated:	April 29, 2008
ClinicalTrials.gov Identifier:	NCT00669552
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Ischemia

Additional relevant MeSH terms:

Pathologic Processes

ClinicalTrials.gov processed this record on January 16, 2009