Cerebral Small Vessel Disease and Perioperative Covert Stroke

Phase

N/A

Condition

Cerebral Ischemia

Stroke

Treatment

N/A

Clinical Study ID

NCT04443933

KY2019-147

Ages 65-85
All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Age from 65 years to 85 years;
The patient is about to have major surgery for the first time and the operation isnon-cardiac surgery;
Written informed consent is obtained before the surgery.

Exclusion

Exclusion Criteria:

mental illness;
Already have other diseases that can cause dementia, such as Alzheimer's disease, Lewybody dementia, Frontotemporal dementia, progressive supranuclear palsy, Parkinson'sdisease, Creutzfeldt-Jakob disease, Huntington's disease, alcohol and drug dependence,Neurosyphilis, systemic lupus erythematosus; or preoperative MRI shows hippocampal andtemporal lobe atrophy more than two levels, suggesting the possibility of Alzheimer'sdisease
Have suffered from other brain diseases (such as stroke, multiple sclerosis, centralnervous system infection with sequelae, etc.);
Preoperative MRI indicates covert stroke
MMSE or MoCA scale cannot be completed due to other reasons (such as hearingimpairment or visual impairment)
MRI contraindications before or after surgery or patients who cannot tolerate MRIimaging
Stage 3 or 4 malignant tumors, and high malignancy and poor prognosis cancer, such aspancreatic cancer, gallbladder cancer, and bile duct cancer.

Study Design

August 01, 2020

December 31, 2023

Study 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.

Connect with a study center

Renji Hospital, Shanghai Jiaotong University School of Medicine
Shanghai,
China
Active - Recruiting

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