Status:
COMPLETED
Cerebral Lesions and Outcome After Cardiac Surgery (CLOCS)
Lead Sponsor:
National Institute of Neurological Disorders and Stroke (NINDS)
Conditions:
Stroke
Cognitive Symptoms
Eligibility:
All Genders
18+ years
Brief Summary
Between 1 and 5 percent of patients who have coronary artery bypass surgery suffer a stroke following surgery, and 30 percent have new brain lesions that do not produce symptoms and are seen only on M...
Detailed Description
Objective. Cardiac surgery is the leading cause of iatrogenic stroke in the United States; 1% to 5% of patients undergoing CABG have a stroke, and 30% have clinically silent new lesions that are detec...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Age 18 years or greater
- Neurologically and cognitively independent prior to surgery (mRS less than 2)
- CABG, aortic or mitral valve replacement, or a combined valve/CABG procedure scheduled within one week
- EXCLUSION CRITERIA:
- Planned concomitant carotid endarterectomy
- Concomitant medical disorders making clinical follow-up of at least 6 months unlikely or impossible (e.g., neoplastic disease, hepatic failure)
- History of dementia, cognitive dysfunction (MMSE score less than 24) or psychotic disorder
- Any current MRI contraindication (cardiac pacemaker or defibrillator, insulin pump, aneurysmal clip, implanted neural stimulator, cochlear implant, metal shrapnel or bullet, etc)
- Definite or possible pacemaker placement at the time of or after surgery
- Inability to give informed consent
- Pregnancy
Exclusion
Key Trial Info
Start Date :
September 9 2006
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 3 2011
Estimated Enrollment :
363 Patients enrolled
Trial Details
Trial ID
NCT00391378
Start Date
September 9 2006
End Date
January 3 2011
Last Update
July 2 2017
Active Locations (1)
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1
Suburban Hospital
Bethesda, Maryland, United States, 20814