- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05970653
Effect of RIC on Cerebral Autoregulation in Patients Undergoing Cerebrovascular Stent Implantation
February 26, 2024 updated by: Yi Yang
Effect of Remote Ischemic Conditioning on Cerebral Autoregulation in Patients Undergoing Cerebrovascular Stent Implantation
The purpose of this study is to determine the effect of remote ischemic conditioning on cerebral autoregulation in patients undergoing cerebrovascular stent implantation.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Interventional
Enrollment (Estimated)
104
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Yi Yang
- Phone Number: 0086-13756661217
- Email: doctor_yangyi@163.com
Study Contact Backup
- Name: Zhenni Guo
- Email: zhen1ni2@163.com
Study Locations
-
-
Jilin
-
Changchun, Jilin, China, 130000
- Recruiting
- First Hospital of Jilin University
-
Contact:
- Zhenni Guo, MD, PhD
- Phone Number: 0086 18186872986
- Email: zhen1ni2@163.com
-
Contact:
- Yi Yang, MD, PhD
- Phone Number: 0086 18186870008
- Email: doctoryangyi@163.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: RIC Group
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.
|
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.
|
Placebo Comparator: Sham-RIC Group
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cerebral autoregulation parameter
Time Frame: 0-7 days
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 2, 2023
Primary Completion (Estimated)
May 31, 2024
Study Completion (Estimated)
August 31, 2024
Study Registration Dates
First Submitted
July 25, 2023
First Submitted That Met QC Criteria
July 25, 2023
First Posted (Actual)
August 1, 2023
Study Record Updates
Last Update Posted (Actual)
February 28, 2024
Last Update Submitted That Met QC Criteria
February 26, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RICCA-CSI
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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