Comparison of the Risk of Stroke With On- Versus Off-Pump Coronary Artery Bypass Grafting
Completed
Conditions studied: Coronary Disease
In brief
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 pictures are being taken. The scan, taken before surgery, will last about 20 minutes; the two after surgery take about 10 minutes to perform.
Key facts
- Study ID
- NCT00046410
- Run by
- National Institute of Neurological Disorders and Stroke (NINDS)
- People needed
- 340
- Starts
- 2002-09-25
- Expected to finish
- 2007-11-15
- Last updated by the study team
- 2017-07-02
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may not qualify if…
- History of CABG
- Need for concomitant major surgery (e.g., valve replacement, resection ventricular aneurysm, congenital heart disease, vascular surgery of the carotid artery or thoracic-abdominal aorta) or salvage or emergency CABG
- Concomitant medical disorders making clinical follow-up of at least 6 months unlikely or impossible (e.g., neoplastic disease, hepatic failure)
- Q-wave myocardial infarction in the previous 6 weeks
- Overt congestive heart failure
- Hemorrhagic diathesis or hypercoagulability
- Any contraindication for off-pump CABG (i.e., thoracic deformities)
- Patients whose procedure requires no clamps (i.e., LIMA to LAD)
- Patients with hemodynamic instability, severe left ventricular dysfunction (ejection fraction less than 25%), significant cardiac enlargement, frequent arrhythmia or respiratory instability
- Carotid stenosis (greater than or equal to 60%) by magnetic resonance angiography or carotid Doppler
- Patients with a history of dementia, cognitive dysfunction (MMSE score less than 24) or psychiatric disorder
- Any MRI contraindication (cardiac pacemaker or defibrillator, insulin pump, aneurysmal clip, implanted neural stimulator, cochlear implant, metal shrapnel or bullet, etc)
- Unable to give informed consent
- Patients with the following intraoperative findings such as 1) hemodynamic instability with positioning, 2) inadequate visualization, 3) inappropriate vessels (i.e., small, intramyocardial), or 4) heavily calcified aorta by palpation
- INCLUSION CRITERIA FOR THE OBSERVATIONAL STUDY
- Age 65 years or greater
- Neurologically and cognitively independent prior to surgery (mRS less than 2)
- Patient scheduled for CABG or aortic or mitral valve replacement within one week
- EXCLUSION CRITERIA FOR THE OBSERVATIONAL STUDY
- Need for concomitant carotid endarterectomy
- Concomitant medical disorders making clinical follow-up of at least 6 months unlikely or impossible (e.g., neoplastic disease, hepatic failure)
- Patients with a history of dementia, cognitive dysfunction (MMSE score less than 24) or psychiatric disorder
- Any MRI contraindication (cardiac pacemaker or defibrillator, insulin pump, aneurysmal clip, implanted neural stimulator, cochlear implant, metal shrapnel or bullet, etc)
- Patient unable to give informed consent
- Participation in other research studies
Where it is running
- Washington Hospital Center — Washington D.C., District of Columbia, United States
Full record on ClinicalTrials.gov
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