Intracardiac T-wave Alternans and Ischemia

Completed

• Conditions: Ischemia
• Interventions: Procedure: Percutaneous coronary intervention

• Registration Number: NCT00669552
• Lead Sponsor: Columbia University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-04-28
• Study First Submitted QC: 2008-04-29
• Study First Posted: 2008-04-30
• Study Start: 2008-08
• Primary Completion: 2012-07
• Study Completion: 2012-07
• Results First Submitted: 2013-02-15
• Results First Submitted QC: 2013-02-15
• Results First Posted: 2013-03-28
• Status Verified: 2013-04
• Last Update Submitted: 2013-04-11
• Last Update Posted: 2013-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

Inclusion Criteria

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

Exclusion Criteria

• non-elective procedure
• non-qualifying defibrillator type.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Medtronic defibrillator	Percutaneous coronary intervention	Patients undergoing a percutaneous coronary intervention (PCI) with an implanted Medtronic defibrillator with the capability of telemetry of the intracardiac signal.

Primary Outcome Measures

Name	Time	Method
Number of Subjects With Positive T Wave Studies During a Coronary Intervention	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.

Trial Locations

Locations (1)

Columbia University Medical Center; 🇺🇸 New York, New York, United States