Intracardiac T-wave Alternans and Ischemia

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.

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Key information

Conditions

Ischemia Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Columbia University Medical Center

New York, 10032, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

patient with CAD undergoing PCI with appropriate Medtronic implantable defibrillator.

Exclusion criteria

non-elective procedure
non-qualifying defibrillator type.

Treatment and study plan

Percutaneous coronary intervention

Procedure

PCI previously electively scheduled.

Primary outcomes

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

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Collaborators

Medtronic

Registry information

Official study title

Intracardiac T-wave Alternans and Ischemia During Percutaneous Coronary Interventions

Important dates

Study start: 2008
Primary completion: 2012
Study completion: 2012
First posted: Apr 30, 2008
Registry last updated: Apr 19, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed