Effect of Remote Ischemic Preconditioning on Cerebral Circulation Time in Patients With Severe Carotid Artery Stenosis (RIP-CCT)
Primary Purpose
Carotid Artery Stenosis
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
remote ischemic preconditioning
Sponsored by
About this trial
This is an interventional treatment trial for Carotid Artery Stenosis
Eligibility Criteria
Inclusion Criteria:
- age 18 years or older, regardless of gender;
- patients with severe carotid stenosis eligible for stenting (70-99% stenosis confirmed by DSA);
- non-responsible vessel stenosis <50% if bilateral carotid stenosis or combined posterior circulation stenosis is present;
- first DSA suggestive of ≥ 0.8 seconds difference (CCT on the affected side - CCT on the healthy side);
- baseline modified Rankin Scale (mRS) ≤ 2 points.
- signed the informed consent form.
Exclusion Criteria:
- baseline mRS ≥ 3 points;
- severe long-segment calcification of the carotid artery, severe distortion of aortic arch branches, anatomical variation of the aortic arch, and etc, which are not suitable for stenting
- spontaneous intracranial hemorrhage within 12 months;
- previous severe stroke or myocardial infarction within 3 months;
- active bleeding and coagulation disorders, which is contraindication to heparin and antiplatelet agents;
- a large intracranial aneurysm that cannot be treated simultaneously;
- severe insufficiency of vital organs such as the heart, lungs, liver and kidneys, or malignant tumors with an expected survival cycle of less than six months;
- total occlusion of carotid artery without obvious cerebral ischemic symptoms
- unable to tolerate anesthesia;
- severe dementia;
- uncontrolled hypertension ;
- allergy to contrast media;
- pregnancy;
- being involved in studies with other drugs or instruments, etc;
- contraindications to remote ischemic preconditioning, such as those with more severe soft tissue injuries, fractures or vascular injuries in the upper extremity, or peripheral vascular lesions in the distal upper extremity.
Sites / Locations
- Department of Neurology, General Hospital of Northern Theater Command
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
remote ischemic preconditioning
control group
Arm Description
Outcomes
Primary Outcome Measures
Changes in cerebral circulation time
Secondary Outcome Measures
changes in contrast staining on brain computerized tomography after carotid artery stenting
changes in collateral scoring based on digital subtraction angiography
occurence of hyperperfusion syndrome after carotid artery stenting
Full Information
NCT ID
NCT05451030
First Posted
July 5, 2022
Last Updated
March 6, 2023
Sponsor
General Hospital of Shenyang Military Region
1. Study Identification
Unique Protocol Identification Number
NCT05451030
Brief Title
Effect of Remote Ischemic Preconditioning on Cerebral Circulation Time in Patients With Severe Carotid Artery Stenosis (RIP-CCT)
Official Title
The Effect of Remote Ischemic Preconditioning on Cerebral Circulation Time in Patients With Severe Carotid Artery Stenosis (RIP-CCT): A Prospective, Randomized Controlled, Blind Outcome Evaluation, Multi-center Study
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
June 28, 2022 (Actual)
Primary Completion Date
March 6, 2023 (Actual)
Study Completion Date
March 6, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
General Hospital of Shenyang Military Region
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Cerebral circulation time in patients with severe carotid artery stenosis was found to be associated with hyperperfusion syndrome. Remote ischemic preconditioning can change the ability of cerebral autoregulation. The prospective, randomized controlled, blind outcome evaluation, multi-center study aimed to investigate the effect of remote ischemic preconditioning on cerebral circulation time in patients with severe carotid artery stenosis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carotid Artery Stenosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
122 (Actual)
8. Arms, Groups, and Interventions
Arm Title
remote ischemic preconditioning
Arm Type
Experimental
Arm Title
control group
Arm Type
Sham Comparator
Intervention Type
Device
Intervention Name(s)
remote ischemic preconditioning
Intervention Description
The cuff of a pneumatic electronic auto-control device placed around the bilateral upper limbs was used to deliver the protocol: 5 cycles of cuff inflation (200mmHg for 5 minutes) and deflation (for 5 minutes), for a total procedure time of 50 minutes, twice daily from the first DSA to the day of carotid artery stenting.
Primary Outcome Measure Information:
Title
Changes in cerebral circulation time
Time Frame
pre-intervention
Secondary Outcome Measure Information:
Title
changes in contrast staining on brain computerized tomography after carotid artery stenting
Time Frame
1 hours and 24 hours after carotid artery stenting
Title
changes in collateral scoring based on digital subtraction angiography
Time Frame
pre-intervention
Title
occurence of hyperperfusion syndrome after carotid artery stenting
Time Frame
24 hours and 7 days after carotid artery stenting
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
age 18 years or older, regardless of gender;
patients with severe carotid stenosis eligible for stenting (70-99% stenosis confirmed by DSA);
non-responsible vessel stenosis <50% if bilateral carotid stenosis or combined posterior circulation stenosis is present;
first DSA suggestive of ≥ 0.8 seconds difference (CCT on the affected side - CCT on the healthy side);
baseline modified Rankin Scale (mRS) ≤ 2 points.
signed the informed consent form.
Exclusion Criteria:
baseline mRS ≥ 3 points;
severe long-segment calcification of the carotid artery, severe distortion of aortic arch branches, anatomical variation of the aortic arch, and etc, which are not suitable for stenting
spontaneous intracranial hemorrhage within 12 months;
previous severe stroke or myocardial infarction within 3 months;
active bleeding and coagulation disorders, which is contraindication to heparin and antiplatelet agents;
a large intracranial aneurysm that cannot be treated simultaneously;
severe insufficiency of vital organs such as the heart, lungs, liver and kidneys, or malignant tumors with an expected survival cycle of less than six months;
total occlusion of carotid artery without obvious cerebral ischemic symptoms
unable to tolerate anesthesia;
severe dementia;
uncontrolled hypertension ;
allergy to contrast media;
pregnancy;
being involved in studies with other drugs or instruments, etc;
contraindications to remote ischemic preconditioning, such as those with more severe soft tissue injuries, fractures or vascular injuries in the upper extremity, or peripheral vascular lesions in the distal upper extremity.
Facility Information:
Facility Name
Department of Neurology, General Hospital of Northern Theater Command
City
Shenyang
ZIP/Postal Code
110016
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Effect of Remote Ischemic Preconditioning on Cerebral Circulation Time in Patients With Severe Carotid Artery Stenosis (RIP-CCT)
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