Status:
UNKNOWN
Remote Ischemic Conditioning on Cerebral Small Vessel Disease
Lead Sponsor:
Capital Medical University
Conditions:
Cerebral Small Vessel Diseases
Eligibility:
All Genders
45-80 years
Phase:
NA
Brief Summary
This trial is a randomized, controlled, single-center, double-blind trial. Cerebral small vessel disease (CSVD) patients will be recruited and randomized into RIC or control group.The protective effec...
Eligibility Criteria
Inclusion
- 45-80 years old, and gender not limited;
- patient and/or caregiver report of cognitive declines with regard to memory and/or other cognitive domains lasting for at least 3 months;
- neither normal nor demented on the basis of the criteria of the Diagnostic and Statistical Manual of Mental Disorders (Fourth Edition) with normal or slightly impaired activities of daily living9, with Mini-mental State Examination (MMSE) score ≥ 20 (primary school) or ≥ 24 (junior school or above)10 and Montreal Cognitive Assessment (MoCA) score ≤ 26;
- the presence of lacunes and/or WMHs and/or CMBs on MRI
- absence of vascular narrowing \>50% luminal diameter that could cause hemodynamic changes (MFV\>90 cm/s for the intracranial internal carotid artery, 100 cm/s for MCA, \>80 cm/s for basilar artery \[BA\] or vertebral artery) measured by TCD
Exclusion
- clinical manifestations indicating that the patient was at the end-stage of cSVD;
- hereditary or inflammatory small vessel disorders
- cerebral venous injury or changes;
- diagnosis of nervous system degenerative diseases Alzheimer's disease, DLB, frontotemporal dementia (FTD), and so on;
- history of intracranial hemorrhage or significant bleeding in other parts of the body
- brain tumor, psychoses, or acute stroke within 6 months;
- cardiogenic embolism;
- significant bleeding coagulation dysfunction;
- serious liver and kidney function is not complete, malignant tumor, or serious diseases need to medical intervention or surgery;
- any soft tissue or vascular injury, and any disease of the extremities that may contraindicate RIC;
- pregnant women;
- life expectancy\<6 months;
- refused to sign a consent form, poor compliance, or not to cooperate to complete whole treatment, and so on.
Key Trial Info
Start Date :
January 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2021
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04816500
Start Date
January 1 2019
End Date
December 31 2021
Last Update
March 25 2021
Active Locations (1)
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1
Xuanwu hospital;Capital Medical University
Beijin, China