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

Carotid Artery Stenosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05451030
• Other study ID #: Y (2022) 022
• Status: Completed
• Phase: N/A
• Start date: June 28, 2022
• Est. completion date: March 6, 2023

Study information

• Verified date: March 2023
• Source: General Hospital of Shenyang Military Region
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 122
• Est. completion date: March 6, 2023
• Est. primary completion date: March 6, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carotid Artery Stenosis
• Carotid Stenosis
• Constriction, Pathologic

Intervention

Device:
• 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.

Locations

Country	Name	City	State
China	Department of Neurology, General Hospital of Northern Theater Command	Shenyang

Sponsors (1)

Lead Sponsor	Collaborator
General Hospital of Shenyang Military Region

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in cerebral circulation time		pre-intervention
Secondary	changes in contrast staining on brain computerized tomography after carotid artery stenting		1 hours and 24 hours after carotid artery stenting
Secondary	changes in collateral scoring based on digital subtraction angiography		pre-intervention
Secondary	occurence of hyperperfusion syndrome after carotid artery stenting		24 hours and 7 days after carotid artery stenting