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NCT00046410 · ClinicalTrials.gov registry record
Comparison of the Risk of Stroke With On- Versus Off-Pump Coronary Artery Bypass Grafting
A clinical trial, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
- Completed
- Registry status
- 340
- Enrollment target
NCT00046410: Completed study, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
NCT00046410 is a clinical trial that has completed, run by National Institute of Neurological Disorders and Stroke (NINDS). The registered enrollment target is 340 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00046410 has completed, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
- COMPLETED
- Registry status
- 340 participants
- Enrollment target
Study Summary
This study will compare the safety of coronary artery bypass grafting (CABG) with and without the use of heart-lung bypass during surgery (on- versus off-pump surgery). CABG carries a risk of stroke and of cognition problems (problems with thought processes) that may be caused by small strokes. This study will use magnetic resonance imaging (MRI) to determine whether the newer technique of off-pump CABG carries a lower risk of stroke than on-pump CABG. The study will also evaluate the relative risk (the risk of stroke in CABG patients exposed to the following factors compared to CABG patients who are not exposed to the following factors) of other factors for stroke and cognitive problems, such as atherosclerosis (hardening of the arteries), age, sex, pre-surgery intellectual function and performance, previous stroke, chronic kidney failure, diabetes, high blood pressure, carotid artery disease (narrowing of the neck arteries to the brain), peripheral blood vessel disease, and micro embolism (tiny blood clots that travel to the brain). Patients 18 years of age and older with chest pain or narrowing of the coronary arteries who are scheduled to undergo CABG surgery may be eligible for this study. Participants will be randomly assigned to have CABG either on-pump or off-pump. They will undergo the following tests and procedures: * Tests of cognitive and neurological function before surgery and 6 months after surgery * Blood tests to look for cytokines (substances that indicate inflammation) before surgery, immediately after surgery and 1 day after surgery * MRI scans to detect stroke before surgery, 1 day after surgery and 1 month after surgery. MRI is a diagnostic test that uses a strong magnetic field and radio waves to show structural and chemical changes in tissue. For the procedure, the patient lies on a table that slides into the scanner-a metal cylinder surrounded by a magnetic field. Earplugs are worn to muffle the loud knocking sounds that occur when the p
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 340 participants |
| Start Date | 2002-09-25 |
| Est. Completion | 2007-11-15 |
What the finished NCT00046410 record still lists
NCT00046410 is an observational study that tracks outcomes without assigning an intervention. The registered 340 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT00046410 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00046410 about?
NCT00046410 is a clinical study titled "Comparison of the Risk of Stroke With On- Versus Off-Pump Coronary Artery Bypass Grafting". This study will compare the safety of coronary artery bypass grafting (CABG) with and without the use of heart-lung bypass during surgery (on- versus off-pump surgery). CABG carries a risk of stroke and of cognition problems (problems with thought processes) that may be caused by small strokes. This...
What is the current status of trial NCT00046410?
This trial is currently completed. The enrollment target is 340 participants. The study started on 2002-09-25. Estimated completion is 2007-11-15.
Who is sponsoring clinical trial NCT00046410?
This trial is sponsored by National Institute of Neurological Disorders and Stroke (NINDS), which has 567 total clinical trials registered on ClinicalTrials.gov.
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