Carotid Artery Stenosis
Conditions
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.
Interventions
DEVICEremote 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.
Sponsors
General Hospital of Shenyang Military Region
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in cerebral circulation time | pre-intervention |
Secondary
| Measure | Time frame |
|---|---|
| changes in contrast staining on brain computerized tomography after carotid artery stenting | 1 hours and 24 hours after carotid artery stenting |
| 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 |
Countries
China
Outcome results
None listed