Ischemia
Conditions
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.
Interventions
PROCEDUREPercutaneous coronary intervention
PCI previously electively scheduled.
Sponsors
Medtronic
Columbia University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* patient with CAD undergoing PCI with appropriate Medtronic implantable defibrillator.
Exclusion criteria
* non-elective procedure * non-qualifying defibrillator type.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Medtronic Defibrillator Patients undergoing a percutaneous coronary intervention (PCI) with an implanted Medtronic defibrillator with the capability of telemetry of the intracardiac signal. | 11 |
| Total | 11 |
Baseline characteristics
| Characteristic | Medtronic Defibrillator |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 4 Participants |
| Age, Categorical Between 18 and 65 years | 7 Participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 11 |
| serious Total, serious adverse events | 0 / 11 |
Outcome results
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.
Time frame: During the coronary intervention, upto 2 hours
Population: Only collected on subjects that had an intervention
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Medtronic Defibrillator | Number of Subjects With Positive T Wave Studies During a Coronary Intervention | 0 participants |