Cerebral Lesions and Outcome After Cardiac Surgery (CLOCS)
Launched by NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE (NINDS) · Oct 21, 2006
Trial Information
Current as of August 11, 2025
Completed
Keywords
ClinConnect Summary
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 detectable only on MRI. Cognitive dysfunction is also common after heart surgery, and up to 40% have long-term cognitive impairment. The primary objective of this study is to define the pre-operative risk profile that best predicts postoperative ischemic or cognitive changes in patients undergoing heart surgery and to 1) establish a registry of patients undergoing cardiac surgery to evaluate the rel...
Gender
ALL
Eligibility criteria
- * 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
About National Institute Of Neurological Disorders And Stroke (Ninds)
The National Institute of Neurological Disorders and Stroke (NINDS) is a leading component of the National Institutes of Health (NIH), dedicated to advancing our understanding of the brain and nervous system through innovative research. NINDS sponsors and conducts clinical trials aimed at developing effective treatments and improving patient outcomes for a wide range of neurological disorders, including stroke, epilepsy, multiple sclerosis, and neurodegenerative diseases. By fostering collaboration among researchers, healthcare providers, and patient communities, NINDS plays a pivotal role in transforming scientific discoveries into clinical applications, ultimately enhancing the quality of life for individuals affected by neurological conditions.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Bethesda, Maryland, United States
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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