NCT04443933

Cerebral Small Vessel Disease and Perioperative Covert Stroke

A Multicenter Prospective Cohort Study of Multimodal MRI in Cerebral Small Vessel Disease and Covert Stroke in Perioperative Patients

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 548 (estimated)
• Sponsor: RenJi Hospital · Academic / Other
• Sex: All
• Age: 65 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

MOCSS study is a multicenter prospective clinical cohort study. The purpose of the MOCSS study is to investigate whether there is a correlation between the preoperative cerebral small vessel disease and the incidence of covert stroke after non-cardiac surgery. Cerebral small vessel disease (CSVD) and covert stroke will be diagnosed using multimodal MRI. This study will also investigate whether preoperative CSVD and postoperative covert stroke are related to postoperative cognitive dysfunction and delirium.

Detailed description

With the growing number of the older population, surgery for elderly patients is on the rise. Elderly patients often have more cardiovascular disease and brain vulnerability and tend to experience more perioperative complications. Perioperative covert stroke is one of those that can been neglected for a long time and is associated with long-term cognitive impairment. While CSVD is an insidious disease mainly affecting small blood vessels in the brain with variable symptoms including dementia, cognitive decline, gait impairment, mood disturbance and stroke. According to the etiopathology of CSVD, there's a possibility that CSVD is a potential risk factor for covert stroke and it may serve as a predictive marker for cognitive decline after surgery. In this multicenter prospective clinical cohort study, the investigators aim to investigate the correlation between the MRI manifestations of cerebral small vessel disease and perioperative covert stroke. Patients aged between 65 to 85 who are scheduled for elective non-cardiac surgeries will be enrolled.The primary outcome is the incidence of perioperative covert stroke diagnosed by MRI. Secondary outcomes include incidence of delirium (using ICU-CAM) within 3 days after surgery and cognitive function tests (using Mini-Mental State Examination and Montreal Cognitive Assessment), physical function test (using ADL, Activities of Daily Living) and dependence test (using modified Rankin Scale) at 3 months, 6 months and 12months after surgery.

Conditions

• Cerebral Small Vessel Diseases
• Covert Postoperative Stroke

Timeline

• Start date: 2020-08-01
• Primary completion: 2023-08-01
• Completion: 2023-12-01
• First posted: 2020-06-23
• Last updated: 2023-06-22

Locations

1 site across 1 country: China