Effect of RIC on Cerebral Autoregulation in Patients Undergoing Cerebrovascular Stent Implantation

NCT05970653 | Recruiting DMC

• 1 other identifier: RICCA-CSI
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the effect of remote ischemic conditioning on cerebral autoregulation in patients undergoing cerebrovascular stent implantation.

Conditions

Remote Ischemic Conditioning

Keywords

Remote Ischemic Conditioning; Cerebrovascular Stent Implantation

Outcome Measures

Primary Outcomes (1)

• Cerebral autoregulation parameter

  Cerebral autoregulation parameters derived from transfer function analysis. Continuous cerebral blood flow velocities of bilateral middle cerebral artery will be assessed noninvasively using transcranial Doppler. Spontaneous arterial blood pressure will be simultaneously recorded using a servo-controlled plethysmograph on the left or right middle finger with an appropriate finger cuff size. Transfer function analysis will be used to derive the autoregulatory parameter.

  0-7 days

Study Arms (2)

RIC Group

ACTIVE COMPARATOR

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 inflation of a blood pressure cuff to 200 mm Hg. RIC will be conducted twice daily for 7 consecutive days or from enrollment to discharge.

Procedure: Remote ischemic conditioning

Sham-RIC Group

PLACEBO COMPARATOR

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 inflation of a blood pressure cuff to 60 mm Hg. RIC will be conducted twice daily for 7 consecutive days or from enrollment to discharge.

Procedure: Sham remote ischemic conditioning

Interventions

Remote ischemic conditioning PROCEDURE

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 inflation of a blood pressure cuff to 200 mm Hg.

RIC Group

Sham remote ischemic conditioning PROCEDURE

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 inflation of a blood pressure cuff to 60 mm Hg.

Sham-RIC Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yi Yang: lead

Study Sites (1)

First Hospital of Jilin University

Changchun, Jilin, 130000, China

RECRUITING

Central Study Contacts

Yi Yang

CONTACT

0086-13756661217; doctor_yangyi@163.com

Zhenni Guo

CONTACT

zhen1ni2@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associated Dean of The First Hospital of Jilin University

Study Record Dates

• First Submitted: July 25, 2023
• First Posted: August 1, 2023
• Study Start: August 2, 2023
• Primary Completion: May 31, 2024
• Study Completion: August 31, 2024
• Last Updated: February 28, 2024

Record last verified: 2024-02

Locations

CN (1)