At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Cerebral Lesions and Outcomes After Cardiac Surgery (CLOCS)
In Brief
An observational study for Stroke and Cognitive Symptoms. Completed, enrolled 363 participants across 1 site.
Detailed 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 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.