Comparison of the Risk of Stroke With On- Versus Off-Pump Coronary Artery Bypass Grafting

Completed

Phase N/A Results N/A

Eligibility Criteria

- INCLUSION CRITERIA:
1. Age 18 years or greater
2. Neurologically and cognitively independent prior to surgery (mRS less than 2)
3. Patients with stable or unstable angina pectoris (Braunwald Class I-II, B) and/or documented ischemia due to single or multivessel disease and a normal, mild or moderately impaired global left ventricular function
4. Patients who are a candidate for CABG
5. Patients who are eligible for on-pump and off-pump CABG: Patients with single or multi-vessel disease in which one or more significant stenosis(es) in at least one major epicardial coronary artery (left anterior descending artery, left circumflex artery, right coronary artery, or the combination of one of the former and a side branch providing different myocardial territories).
EXCLUSION CRITERIA:
1. History of CABG
2. 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
3. Concomitant medical disorders making clinical follow-up of at least 6 months unlikely or impossible (e.g., neoplastic disease, hepatic failure)
4. Q-wave myocardial infarction in the previous 6 weeks
5. Overt congestive heart failure
6. Hemorrhagic diathesis or hypercoagulability
7. Any contraindication for off-pump CABG (i.e., thoracic deformities)
8. Patients whose procedure requires no clamps (i.e., LIMA to LAD)
9. Patients with hemodynamic instability, severe left ventricular dysfunction (ejection fraction less than 25%), significant cardiac enlargement, frequent arrhythmia or respiratory instability
10. Carotid stenosis (greater than or equal to 60%) by magnetic resonance angiography or carotid Doppler
11. Patients with a history of dementia, cognitive dysfunction (MMSE score less than 24) or psychiatric disorder
12. Any MRI contraindication (cardiac pacemaker or defibrillator, insulin pump, aneurysmal clip, implanted neural stimulator, cochlear implant, metal shrapnel or bullet, etc)
13. Unable to give informed consent
14. 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
1. Age 65 years or greater
2. Neurologically and cognitively independent prior to surgery (mRS less than 2)
3. Patient scheduled for CABG or aortic or mitral valve replacement within one week
EXCLUSION CRITERIA FOR THE OBSERVATIONAL STUDY
1. Need for concomitant carotid endarterectomy
2. Concomitant medical disorders making clinical follow-up of at least 6 months unlikely or impossible (e.g., neoplastic disease, hepatic failure)
3. Patients with a history of dementia, cognitive dysfunction (MMSE score less than 24) or psychiatric disorder
4. Any MRI contraindication (cardiac pacemaker or defibrillator, insulin pump, aneurysmal clip, implanted neural stimulator, cochlear implant, metal shrapnel or bullet, etc)
5. Patient unable to give informed consent
6. Participation in other research studies