Cerebral Lesions and Outcome After Cardiac Surgery (CLOCS)
Completed
Conditions studied: Stroke, Cognitive Symptoms
In brief
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 MRI. In addition, up to 40 percent of patients develop long-term cognitive impairment. This study will identify risk factors that predict whether a person undergoing heart surgery will develop cerebral infarcts after surgery. It will also identify operative and inflammatory factors that may alter the risk, and will evaluate whether the small lesions are associated with cognitive decline at 6 months. People 18 years of age or older who will undergo coronary artery bypass surgery (CABG), heart valve replacement, or combined CABG and valve replacement procedure are eligible for this study. Candidates must have no neurological or cognitive impairment before surgery. Participants will undergo standard medical and surgical treatment as determined by their physicians. In addition, they have the following procedures: * Medical and neurological evaluation before surgery and 24 and 48 hours after surgery. * Brain MRI before surgery, and 48 hours, 30 days and 6 months after surgery. * Blood draws before surgery, immediately after surgery, and 6, 24, 48 and 72 hours after surgery to quantify the response of their inflammatory system to surgery. * Neuropsychological examinations 30 days and 6 months after surgery. * In addition, patients who agree to enroll in a substudy that will explore whether differences in the genes coding for inflammatory molecules lead to a change in the risk of iscjhemia after heart surgery, will have extra blood drawn for genetic analysis.
Key facts
- Study ID
- NCT00391378
- Run by
- National Institute of Neurological Disorders and Stroke (NINDS)
- People needed
- 363
- Starts
- 2006-09-09
- Expected to finish
- 2011-01-03
- 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…
- 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
Where it is running
- Suburban Hospital — Bethesda, Maryland, United States
Full record on ClinicalTrials.gov
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