Intracardiac T-wave Alternans and Ischemia

NCT00669552 | Completed Results

• 1 other identifier: AAAC6715
• Study Type: observational
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Ischemia

Outcome Measures

Primary Outcomes (1)

• Number of Subjects With Positive T Wave Studies During a Coronary Intervention

  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.

  During the coronary intervention, upto 2 hours

Study Arms (1)

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

Interventions

Percutaneous coronary intervention PROCEDURE

PCI previously electively scheduled.

Medtronic defibrillator

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Columbia University: lead
• Medtronic: collaborator

Study Sites (1)

Columbia University Medical Center

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Ischemia

Interventions

Percutaneous Coronary Intervention

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Results Point of Contact

• Title: Jose' Dizon, MD
• Organization: Columbia University

jmd11@columbia.edu

212-305-8559

Study Officials

• Jose M Dizon, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc Professor of Clinical, Department of Medicine Cardiology

Study Record Dates

• First Submitted: April 28, 2008
• First Posted: April 30, 2008
• Study Start: August 1, 2008
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: April 19, 2013
• Results First Posted: March 28, 2013

Record last verified: 2013-04

Locations

US (1)