Remote ischemic conditioning effects on patients with cerebral small vessel disease

Effects of Remote Ischemic Conditioning on Dynamic Cerebral Autoregulation, Blood Pressure and Heart Rate Variability in Patients With Cerebral Small Vessel Disease

This study is testing if a special treatment called remote ischemic conditioning can improve blood flow and heart health in people with cerebral small vessel disease.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sex: All
• Sponsor: The First Hospital of Jilin University (Academic / other)
• Locations: 1 site (Changchun, Jilin)
• Trial ID: NCT05225948 on ClinicalTrials.gov

What this trial studies

This study investigates the effects of remote ischemic conditioning on dynamic cerebral autoregulation, blood pressure, and heart rate variability in patients diagnosed with cerebral small vessel disease. A total of 100 patients will be divided into two groups, with one receiving higher intensity remote ischemic conditioning and the other receiving a lower intensity treatment, both in addition to standard medical care. The patients will undergo monitoring at baseline, after 3-4 days of treatment, and at the end of the intervention period. Follow-up assessments will occur over 90 days to evaluate the outcomes of the treatment.

Who should consider this trial

Good fit: Ideal candidates are patients diagnosed with cerebral small vessel disease who can start treatment within 7 days of symptom onset.

Not a fit: Patients with significant vascular stenosis, a history of intracranial hemorrhage, or major bleeding are unlikely to benefit from this study.

Why it matters

Potential benefit: If successful, this approach could improve cerebral autoregulation and cardiovascular health in patients with cerebral small vessel disease.

How similar studies have performed: While remote ischemic conditioning has shown promise in other contexts, this specific application in cerebral small vessel disease is relatively novel.

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.

Where this trial is running

Changchun, Jilin

• The First Hospital of Jilin University — Changchun, Jilin, China (Recruiting)

Study contacts

• Study coordinator: Yi Yang, MD, PhD

Conditions Cerebral Small Vessel Diseases