Effect of Remote Ischemic Preconditioning on Cerebral Circulation Time in Patients With Severe Carotid Artery Stenosis (RIP-CCT)

Not Applicable

Completed

• Conditions: Carotid Artery Stenosis
• Interventions: Device: remote ischemic preconditioning

• Registration Number: NCT05451030
• Lead Sponsor: General Hospital of Shenyang Military Region

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-06-28
• Study First Submitted: 2022-07-05
• Study First Submitted QC: 2022-07-07
• Study First Posted: 2022-07-11
• Status Verified: 2023-03
• Primary Completion: 2023-03-06
• Study Completion: 2023-03-06
• Last Update Submitted: 2023-03-06
• Last Update Posted: 2023-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 122

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control group	remote ischemic preconditioning	-
remote ischemic preconditioning	remote ischemic preconditioning	-

Primary Outcome Measures

Name	Time	Method
Changes in cerebral circulation time	pre-intervention

Secondary Outcome Measures

Name	Time	Method
changes in collateral scoring based on digital subtraction angiography	pre-intervention
occurence of hyperperfusion syndrome after carotid artery stenting	24 hours and 7 days after carotid artery stenting
changes in contrast staining on brain computerized tomography after carotid artery stenting	1 hours and 24 hours after carotid artery stenting

Trial Locations

Locations (1)

Department of Neurology, General Hospital of Northern Theater Command; 🇨🇳 Shenyang, China