Cerebral Small Vessel Disease
Conditions
Keywords
remote ischemic preconditioning, random-controlled, double blind, RIPC
Brief summary
The hypothesis of this study is that remote ischemic preconditioning (RIPC) might have a beneficial effect on outcomes of cerebral small vessel disease (CSV).
Detailed description
CSV constitutes an important type of ischemic stroke due to a generalized hypo-perfusion of brain. Few treatment methods are available except some beneficial effect shown with nimodipine. The potential treatment effect of RIPC on protection of brain from cerebral small vessel disease has not been investigated. The investigators designed this randomized, double-blind, controlled clinical trial to examine (1) whether RIPC has a beneficial effect on brain lesions of CSV, and (2) whether RIPC can protect patients of CSV from cognitive deterioration. There are 2 arms in this trial: One arm is RIPC treatment, the other one is sham RIPC treatment. Brain lesions will be quantified by volumetric MRI, and Xe-CT will be used to evaluate cerebral blood perfusion. Cognitive function will be evaluated by mini-mental state examination (MMSE) and the Montreal Cognitive Assessment (MoCA).
Interventions
PROCEDUREremote ischemic preconditioning
RIPC consists of five 5-min cycles of right upper arm ischemia/reperfusion, induced by an automated cuff-inflator placed on the right upper arm which is inflated to 200 mmHg for 5mins followed by deflating the cuff for 5mins, each patient in the RIPC group will have the treatment twice a day for two weeks.
PROCEDUREsham remote ischemic preconditioning
Sham RIPC consists of five 5-min cycles of right upper arm ischemia/reperfusion, induced by an automated cuff-inflator placed on the right upper arm which is inflated to 50 mmHg for 5mins followed by deflating the cuff for 5mins, each patient in the placebo RIPC group will have the treatment twice a day for two weeks.
Sponsors
Peking University First Hospital
Capital Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Subjects aged 40-80 years; 2. Ischemic cerebrovascular event onset, if any, must be within 6 months; 3. TCD and carotid ultrasound exclude vascular narrow that can cause hemodynamic changes (usually \>50% narrow lumen); 4. MRI confirmed the presence of lacunar infarction and / or generalized white matter lesions; 5. Written consent was obtained from the subject.
Exclusion criteria
1. History of intracranial hemorrhage; 2. Significant bleeding from other parts of the body; 3. History of atrial fibrillation; 4. History of myocardial infarction within six months; 5. Moyamoya disease or vasculitis; 6. Hereditary small vessel disorders, such as CADASIL, FABRY, and mitochondrial encephalo-myopathy; 7. Significant bleeding-coagulation dysfunction; 8. Abnormal blood pressure, glucose and/or lipids after restrict treatment regimen; 9. Severe liver/kidney disease, cancer or critical illness of internal medicine and surgery.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| changes in brain lesions | 0-24 months | Volumetric MRI will be used for calculating changes in the number of lacunar infarctions and the total volume of white matter lesions |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in the cognitive function | 0-24 months | Cognitive function will be evaluated by mini-mental state examination (MMSE) and the Montreal Cognitive Assessment (MoCA). |
| Changes in the cerebral blood perfusion | 0-24 months | Cerebral blood perfusion will be evaluated by Xe-CT. |
Countries
China
Outcome results
None listed