Effect of remote ischemic conditioning on brain blood flow regulation during stent placement

Effect of Remote Ischemic Conditioning on Cerebral Autoregulation in Patients Undergoing Cerebrovascular Stent Implantation

This study is testing if a special treatment called remote ischemic conditioning can help improve blood flow in the brain for patients getting a stent placed in their blood vessels.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 104 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: The First Hospital of Jilin University (Academic / other)
• Locations: 1 site (Changchun, Jilin)
• Trial ID: NCT05970653 on ClinicalTrials.gov

What this trial studies

This study investigates how remote ischemic conditioning (RIC) influences cerebral autoregulation in patients undergoing cerebrovascular stent implantation. A total of 104 patients will be enrolled and randomly assigned to either the RIC group, which receives conditioning at 200mmHg, or the sham-RIC group, which receives conditioning at 60mmHg. Both groups will undergo treatment twice daily for seven consecutive days or until discharge, and their cerebral autoregulation will be evaluated through follow-up assessments. The goal is to determine if RIC can improve brain blood flow regulation during this procedure.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with symptomatic or asymptomatic cerebral vascular stenosis who are scheduled for elective cerebrovascular stenting.

Not a fit: Patients with progressive stroke, significant pre-existing disability, or contraindications to remote ischemic conditioning may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could enhance cerebral blood flow regulation, potentially reducing complications during cerebrovascular stent implantation.

How similar studies have performed: While the concept of remote ischemic conditioning has been explored in various contexts, this specific application in cerebrovascular stenting is relatively novel and has not been extensively tested.

Eligibility criteria

Inclusion Criteria:

* Age≥18 years, regardless of sex;
* Patients with symptomatic or asymptomatic cerebral vascular stenosis (including internal carotid artery system and vertebrobasilar system) who are candidates for elective cerebrovascular stenting.
* Patients or their immediate family members are able and willing to sign informed consent.

Exclusion Criteria:

* Patients with progressive stroke;
* mRS≥ 2 points before admission;
* Patients with other surgical treatments;
* Patients with other serious diseases or a life expectancy of less than 3 months
* Patients who had contraindication of remote ischemic conditioning, such as severe soft tissue injury, fracture or vascular injury in the upper extremities, venous thrombosis in the acute or subacute stage of upper extremities;
* Laboratory test indicators are unqualified: aspartate aminotransferase or alanine aminotransferase is 3 times higher than the upper limit of the normal range, blood creatinine \> 265umol/L (\>3mg/dl), platelet \< 100×109/L, international normalized ratio (INR), activated partial thromboplastin time (APTT), prothrombin time (PT) exceed the upper limit of the normal range;
* Pregnant or lactating women;
* Patients who are participating in other clinical studies, or who have participated in other clinical studies within 3 months prior to enrollment;
* Unwillingness to be followed up or poor adherence to treatment;
* Other circumstances that the investigator considers unsuitable for enrolment.

Where this trial is running

Changchun, Jilin

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

Study contacts

• Study coordinator: Yi Yang

Conditions Remote Ischemic Conditioning; Cerebrovascular Stent Implantation