Cerebral Small Vessel Disease and Perioperative Covert Stroke
NCT ID: NCT04443933
Last Updated: 2023-06-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
548 participants
OBSERVATIONAL
2020-08-01
2023-12-31
Brief Summary
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Detailed Description
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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
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Cerebral Small Vessel Disease
In this group, patients are diagnosed with cerebral small vessel disease preoperatively using multimodal MRI.
No interventions assigned to this group
non-Cerebral Small Vessel Disease
In this group, cerebral small vessel disease is ruled out by preoperative multimodal MRI.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
65 Years
85 Years
ALL
No
Sponsors
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RenJi Hospital
OTHER
Responsible Party
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Locations
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Renji Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, , China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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KY2019-147
Identifier Type: -
Identifier Source: org_study_id
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