Effects of Remote Ischemic Conditioning on Dynamic Cerebral Autoregulation, Blood Pressure and Heart Rate Variability in Patients With Cerebral Small Vessel Disease (ESCAPE-SVD)
Cerebral Small Vessel Diseases
About this trial
This is an interventional treatment trial for Cerebral Small Vessel Diseases
Eligibility Criteria
Inclusion Criteria:
- 1) Regardless of age, sex;
2) Patients are diagnosed with cerebral small vessel disease, and neuroimaging shows new subcortical lacunar infarction (in line with one of the following):
① MRI examination Diffusion-weighted imaging (DWI) phase shows high signal intensity [Apparent Diffusion Coefficient (ADC) diffusion restriction] lesions < 20 mm diameter in subcortical, basal ganglia or brainstem , with or without corresponding clinical symptoms;
② With new clinical symptoms, MRI examination FLAIR sequence shows corresponding FLAIR high signal intensity lesions [diameter < 20 mm]) in subcortical, basal ganglia or pons;
- 3) Remote ischemic conditioning can be started within 7 days from onset;
- 4) Willing to participate and sign the informed consent.
Exclusion Criteria:
- 1) Vascular stenosis > 50% by Transcranial Doppler (TCD);
- 2) Previous history of intracranial hemorrhage or major bleeding in other parts of the body;
- 3) Previous history of atrial fibrillation or myocardial infarction within 6 months;
- 4) Moyamoya disease or hereditary cerebral small vessel disease, such as mitochondrial encephalopathy, CADASIL or Fabry;
- 5) The patients who had clear non-vascular white matter lesions, such as multiple sclerosis, adult white matter dysplasia, metabolic encephalopathy;
- 6) Severe hepatic and renal diseases, cancer or other major diseases related to medical and surgical procedures;
- 7) The patients who had the contraindication of remote ischemic conditioning treatment, such as severe soft tissue injury, fracture or vascular injury in the upper limb; Acute or subacute venous thrombosis, arterial occlusive disease, subclavian steal syndrome, etc;
- 8) Significant coagulation abnormalities;
- 9) Pregnant or lactating women;
- 10) The patients with disturbance of consciousness or agitation who cannot cooperate to dynamic cerebral autoregulation monitoring or beat-to-beat blood pressure monitoring;
- 11) Previous remote ischemic conditioning therapy or similar treatment;
- 12) Unwilling to be followed up or treated for poor compliance;
- 13) He/She is participating in other clinical research or has participated in other clinical research or has participated in this study within 3 months prior to admission;
- 14) Other conditions that the researchers think are not suitable for the group.
Sites / Locations
- The First Hospital of Jilin UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Placebo Comparator
RIC+Standard medical treatment
Sham RIC+Standard medical treatment
Remote ischemic conditioning (RIC) is induced by 4 cycles of 5 min of healthy upper limb ischemia followed by 5 min reperfusion. Limb ischemia was induced by inflations of a blood pressure cuff to 200 mmHg. RIC will be conducted twice daily during the period of hospitalization. Besides, the patients will be treated with standard medical treatment according to consensus on diagnosis and treatment of cerebral small vessel disease in China 2015, including antiplatelet aggregation and lipid-stabilizing drugs as well as neurotrophic and circulation improving treatment.
Remote ischemic conditioning (RIC) is induced by 4 cycles of 5 min of healthy upper limb ischemia followed by 5 min reperfusion. Limb ischemia was induced by inflations of a blood pressure cuff to 60 mmHg. RIC will be conducted twice daily during the period of hospitalization. Besides, the patients will be treated with standard medical treatment according to consensus on diagnosis and treatment of cerebral small vessel disease in China 2015, including antiplatelet aggregation and lipid-stabilizing drugs as well as neurotrophic and circulation improving treatment.