Cerebral Small Vessel Disease and Perioperative Covert Stroke

Cerebral Small Vessel Diseases Clinical Trial

— MOCSS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04443933
• Other study ID #: KY2019-147
• Status: Recruiting
• Start date: August 1, 2020
• Est. completion date: December 2023

Study information

• Verified date: June 2023
• Source: RenJi Hospital
• Contact: Peiying Li, MD,PhD
• Phone: 8615800616866
• Email: peiyingli.md[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 548
• Est. completion date: December 2023
• Est. primary completion date: August 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 85 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Cerebral Small Vessel Diseases
• Covert Postoperative Stroke
• Stroke

Locations

Country	Name	City	State
China	Renji Hospital, Shanghai Jiaotong University School of Medicine	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
RenJi Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of postoperative covert stroke	We will use MRI to detect postoperative covert stroke as soon as patients can tolerate MRI.	14 days
Secondary	Incidence of overt stroke after surgery	Incidence of overt stroke will be measured by obtaining medical history.	3 months, 6 months and 12 months
Secondary	Modified Rankin Scale after surgery	The Modified Rankin Scale measures the degree of disability or dependence in the daily activities of people after stroke or other neurological disability.Minimum value:0, Maximum value:6. Higher scores mean a worse outcome.	3 months, 6 months and 12 months
Secondary	Cognitive Function assessed by Montreal Cognitive Assessment Scale	We will use Montreal Cognitive Assessment (MoCA) scale to assess cognitive function after surgery. Minimum value:0, Maximum value: 30. Higher scores mean a better outcome.	3 months, 6 months and 12 months
Secondary	Cognitive Function assessed by Mini-Mental State Examination Scale	We will use Mini-Mental State Examination (MMSE) scale to assess cognitive function after surgery. Minimum value:0, Maximum value: 30. Higher scores mean a better outcome.	3 months, 6 months and 12 months
Secondary	Incidence of delirium	Incidence of delirium will be measured using Intensive Care Unit-Cognitive Assessment Method (ICU-CAM) every 12 hours till the 72 hours after surgery.	72 hours
Secondary	Physical functions after surgery	The investigators will use Activities of daily living (ADL) scale to measure physical function after surgery. Minimum value:0, Maximum value: 78. Higher scores mean a better outcome.	3 months, 6 months and 12 months