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

NCT ID: NCT05451030

Last Updated: 2023-03-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 122 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-28
• Study Completion Date: 2023-03-06

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.

Conditions

Carotid Artery Stenosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

remote ischemic preconditioning

Group Type: EXPERIMENTAL

remote ischemic preconditioning

Intervention Type: DEVICE

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.

control group

Group Type: SHAM_COMPARATOR

remote ischemic preconditioning

Intervention Type: DEVICE

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.

Interventions

remote ischemic preconditioning

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.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

General Hospital of Shenyang Military Region

OTHER

Sponsor Role: lead

Responsible Party

Hui-Sheng Chen

Head of Neurology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Department of Neurology, General Hospital of Northern Theater Command

Shenyang, , China

Countries

China

References

Liu QY, Cui Y, Li W, Qiu J, Nguyen TN, Chen HS. Effect of remote ischemic preconditioning on cerebral circulation time in severe carotid artery stenosis: Results from the RIC-CCT trial. Cell Rep Med. 2024 Nov 19;5(11):101796. doi: 10.1016/j.xcrm.2024.101796. Epub 2024 Oct 28.

Reference Type: DERIVED

PMID: 39471820 (View on PubMed)

Other Identifiers

Y (2022) 022

Identifier Type: -

Identifier Source: org_study_id