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Remote ischemic conditioning (RIC) has emerged as a promising non-invasive strategy to protect the brain, with evidence suggesting its benefit in patients with carotid artery stenting (CAS). However, the long-term benefit and safety of chronic RIC in this population remain unknown. This trial aims to evaluate whether chronic RIC reduces the incidence of major vascular events and improves clinical outcomes in high-risk patients with carotid artery stenosis who received CAS.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RIC group | Experimental | The RIC protocol involves bilateral upper-arm cuff inflation to 200 mmHg (5-min inflation/5-min deflation, 5 cycles) performed 1-2 times daily, starting 3 days before CAS and continuing for 12 months post-procedure. |
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| Control group | No Intervention | no RIC treatment |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remote ischemic conditioning | Device | The RIC protocol involves bilateral upper-arm cuff inflation to 200 mmHg (5-min inflation/5-min deflation, 5 cycles) performed 1-2 times daily, starting 3 days before CAS and continuing for 12 months post-procedure. |
| Measure | Description | Time Frame |
|---|---|---|
| time to the first occurrence of any component of the composite endpoint within 12 months post-randomization | the composite endpoint includes ischemic stroke, hemorrhagic stroke, myocardial infarction [including coronary revascularization], TIA, or vascular death | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| composite of periprocedural death, stroke, or myocardial infarction | 30±3 days | |
| occurence of non-fatal stroke and TIA | 1 year | |
| occurence of nonfatal myocardial infarction |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Neurology, General Hospital of Northern Theater Command | Recruiting | Shenyang | 110016 | China |
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| ID | Term |
|---|---|
| D016893 | Carotid Stenosis |
| ID | Term |
|---|---|
| D002340 | Carotid Artery Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| 1 year |
| numbers of new silent cerebral infarcts on Magnetic Resonance Imaging | 1 year |
| occurence of ipsilateral (to the stented artery) nonfatal stroke and transient ischemic attack | 1 year |
| degree of in-stent restenosis (≥50%) on Computed Tomography Angiography | 1 year |
| change in collateral circulation status (assessed by Computed Tomography Angiography or Digital Subtraction Angiograph) from baseline to 12 months | 1 year |
| all-cause mortality | 1 year |
| changes in modified Rankin Scale (mRS) scores over time | The minimum and maximum values of mRS are 0 and 6, respectively; higher score mean a worse outcome | 1 year |
| occurrence of contrast staining on brain computerized tomography | 1 hours and 24 hours after carotid artery stenting |
| occurrence of cerebral hyperperfusion syndrome | 24 hours after carotid artery stenting |
| occurence of new infarct on brain magnetic resonance imaging | 24 hours after carotid artery stenting |
| D009422 | Nervous System Diseases |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |