Status:
RECRUITING
Effects of Remote Ischemic Conditioning on Dynamic Cerebral Autoregulation, Blood Pressure and Heart Rate Variability in Patients With Cerebral Small Vessel Disease
Lead Sponsor:
Yi Yang
Conditions:
Cerebral Small Vessel Diseases
Eligibility:
All Genders
Phase:
NA
Brief Summary
The purpose of this study is to determine effects of remote ischemic conditioning on dynamic cerebral autoregulation, blood pressure and heart rate variability in patients with cerebral small vessel d...
Detailed Description
In this study, 100 cases of cerebral small vessel disease in the First Hospital of Jilin University are divided into 2 groups according to the intention of the individual. On the basis of standard med...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 30 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 31 2025
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT05225948
Start Date
December 30 2021
End Date
October 31 2025
Last Update
March 1 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
The First Hospital of Jilin University
Changchun, Jilin, China, 130000