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| Name | Class |
|---|---|
| Medtronic | INDUSTRY |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Medtronic defibrillator | Patients undergoing a percutaneous coronary intervention (PCI) with an implanted Medtronic defibrillator with the capability of telemetry of the intracardiac signal. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Percutaneous coronary intervention | Procedure | PCI previously electively scheduled. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with coronary artery disease (CAD) undergoing PCI that also have an appropriate Medtronic implantable defibrillator.
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| Name | Affiliation | Role |
|---|---|---|
| Jose M Dizon, MD | Columbia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Columbia University Medical Center | New York | New York | 10032 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Medtronic Defibrillator | Patients undergoing a percutaneous coronary intervention (PCI) with an implanted Medtronic defibrillator with the capability of telemetry of the intracardiac signal. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Medtronic Defibrillator | Patients undergoing a percutaneous coronary intervention (PCI) with an implanted Medtronic defibrillator with the capability of telemetry of the intracardiac signal. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Only collected on subjects that had an intervention | Posted | Number | participants | During the coronary intervention, upto 2 hours |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Medtronic Defibrillator | Patients undergoing a percutaneous coronary intervention (PCI) with an implanted Medtronic defibrillator with the capability of telemetry of the intracardiac signal. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jose' Dizon, MD | Columbia University | 212-305-8559 | jmd11@columbia.edu |
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| ID | Term |
|---|---|
| D007511 | Ischemia |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D062645 | Percutaneous Coronary Intervention |
| ID | Term |
|---|---|
| D057510 | Endovascular Procedures |
| D014656 | Vascular Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Participants |
|
|
| 0 |
| 11 |
| 0 |
| 11 |
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| D019060 | Minimally Invasive Surgical Procedures |