Cerebral Lesions and Outcome After Cardiac Surgery (CLOCS)

NCT00391378 | Completed

• 2 other identifiers: 99990624506-N-N245
• Study Type: observational
• Target: 363
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Stroke; Cognitive Symptoms

Keywords

Diffusion-Weighted Magnetic Resonance Imaging; MRI (Magnetic Resonance Imaging); Stroke; Cognition; Heart

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

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

Sponsors & Collaborators

• National Institute of Neurological Disorders and Stroke (NINDS): lead

Study Sites (1)

Suburban Hospital

Bethesda, Maryland, 20814, United States

Location

Related Publications (3)

• Selnes OA, Goldsborough MA, Borowicz LM, McKhann GM. Neurobehavioural sequelae of cardiopulmonary bypass. Lancet. 1999 May 8;353(9164):1601-6. doi: 10.1016/S0140-6736(98)07576-X.

  PMID: 10334272 BACKGROUND

• Stamou SC, Hill PC, Dangas G, Pfister AJ, Boyce SW, Dullum MK, Bafi AS, Corso PJ. Stroke after coronary artery bypass: incidence, predictors, and clinical outcome. Stroke. 2001 Jul;32(7):1508-13. doi: 10.1161/01.str.32.7.1508.

  PMID: 11441193 BACKGROUND

• Breuer AC, Furlan AJ, Hanson MR, Lederman RJ, Loop FD, Cosgrove DM, Greenstreet RL, Estafanous FG. Central nervous system complications of coronary artery bypass graft surgery: prospective analysis of 421 patients. Stroke. 1983 Sep-Oct;14(5):682-7. doi: 10.1161/01.str.14.5.682.

  PMID: 6606871 BACKGROUND

MeSH Terms

Conditions

Stroke; Neurobehavioral Manifestations

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Time Perspective: OTHER
• Sponsor Type: NIH

Study Record Dates

• First Submitted: October 21, 2006
• First Posted: October 24, 2006
• Study Start: September 9, 2006
• Study Completion: January 3, 2011
• Last Updated: July 2, 2017

Record last verified: 2011-01-03

Locations

US (1)