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

Remote Ischemic Conditioning Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05970653
• Other study ID #: RICCA-CSI
• Status: Recruiting
• Phase: N/A
• Start date: August 2, 2023
• Est. completion date: August 31, 2024

Study information

• Verified date: February 2024
• Source: The First Hospital of Jilin University
• Contact: Yi Yang
• Phone: 0086-13756661217
• Email: doctor_yangyi[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

In this study, 104 cases of patients with cerebrovascular stent implantation will be enrolled in the First Hospital of Jilin University, and they will be divided into the RIC group and the sham-RIC group. The RIC group received remote ischemic conditioning for 200mmHg, 2 times per day for 7 consecutive days or from enrollment to discharge. The sham-RIC group received remote ischemic conditioning for 60mmHg, 2 times per day for 7 consecutive days or from enrollment to discharge. Two groups will be followed up to evaluate the effect of remote ischemic conditioning on cerebral autoregulation in patients undergoing cerebrovascular stent implantation.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 104
• Est. completion date: August 31, 2024
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Ischemia
• Remote Ischemic Conditioning

Intervention

Procedure:
• Remote ischemic conditioning
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.
• Sham remote ischemic conditioning
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.

Locations

Country	Name	City	State
China	First Hospital of Jilin University	Changchun	Jilin

Sponsors (1)

Lead Sponsor	Collaborator
Yi Yang

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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