Trial Outcomes & Findings for Intracardiac T-wave Alternans and Ischemia (NCT NCT00669552)
NCT ID: NCT00669552
Last Updated: 2013-04-19
Results Overview
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.
Recruitment status
COMPLETED
Target enrollment
11 participants
Primary outcome timeframe
During the coronary intervention, upto 2 hours
Results posted on
2013-04-19
Participant Flow
Participant milestones
| Measure |
Medtronic Defibrillator
Patients undergoing a percutaneous coronary intervention (PCI) with an implanted Medtronic defibrillator with the capability of telemetry of the intracardiac signal.
|
|---|---|
|
Overall Study
STARTED
|
11
|
|
Overall Study
COMPLETED
|
11
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Intracardiac T-wave Alternans and Ischemia
Baseline characteristics by cohort
| Measure |
Medtronic Defibrillator
n=11 Participants
Patients undergoing a percutaneous coronary intervention (PCI) with an implanted Medtronic defibrillator with the capability of telemetry of the intracardiac signal.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: During the coronary intervention, upto 2 hoursPopulation: Only collected on subjects that had an 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.
Outcome measures
| Measure |
Medtronic Defibrillator
n=5 Participants
Patients undergoing a percutaneous coronary intervention (PCI) with an implanted Medtronic defibrillator with the capability of telemetry of the intracardiac signal.
|
|---|---|
|
Number of Subjects With Positive T Wave Studies During a Coronary Intervention
|
0 participants
|
Adverse Events
Medtronic Defibrillator
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place