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

General Hospital of Northern Theater Command of Chinese People's Liberation Army

Status

Completed

Conditions

Carotid Artery Stenosis

Treatments

Device: remote ischemic preconditioning

Study type

Interventional

Funder types

Other

Identifiers

NCT05451030

Y (2022) 022

Details and patient eligibility

About

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.

Enrollment

122 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.