Intracardiac T-wave Alternans and Ischemia
This study has been completed.
Sponsor:
Columbia University
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
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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | April 28, 2008 | ||||
| Last Updated Date | April 11, 2013 | ||||
| Start Date ICMJE | August 2008 | ||||
| Primary Completion Date | July 2012 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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. |
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| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT00669552 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Intracardiac T-wave Alternans and Ischemia | ||||
| Official Title ICMJE | Intracardiac T-wave Alternans and Ischemia During Percutaneous Coronary Interventions | ||||
| 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Patients with coronary artery disease (CAD) undergoing PCI that also have an appropriate Medtronic implantable defibrillator. |
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| Condition ICMJE | Ischemia | ||||
| Intervention ICMJE | Procedure: Percutaneous coronary intervention
PCI previously electively scheduled. |
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| Study Group/Cohort (s) | 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 |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 11 | ||||
| Completion Date | July 2012 | ||||
| Primary Completion Date | July 2012 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00669552 | ||||
| Other Study ID Numbers ICMJE | AAAC6715 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Jose M. Dizon, Columbia University | ||||
| Study Sponsor ICMJE | Columbia University | ||||
| Collaborators ICMJE | Medtronic | ||||
| Investigators ICMJE |
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| Information Provided By | Columbia University | ||||
| Verification Date | April 2013 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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