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Remote limb ischemic preconditioning (RIPC) has neuro-protective and anti-inflammatory effects on ischemia- reperfusion injury. As the extent of its effect is unknown, the investigators will use clinical outcome, serum biochemical markers and brain magnetic resonance imaging (MRI) to determine whether RIPC has neuro-protective and anti-inflammatory effects on patients undergoing carotid artery stenting.
BACKGROUND: Brain ischemia and injury contributed to perioperative morbidity and mortality in Carotid Artery Stenting. Remote ischemic preconditioning (RIPC), brief periods of ischemia followed by reperfusion, can provide systemic protection for prolonged ischemia. Our previous study found no significant protection to the patients who received once RIPC before Carotid Artery Stenting. In order to investigate whether long-term RIPC before Carotid Artery Stenting can protect these patients from the perioperative and long-term complications, a prospective randomized controlled trial will be performed in the current study.
DESIGNING: About 189 patients who are eligible for carotid artery stenting will be randomly assigned in 1:1:1 ratio to RIPC group, sham RIPC group and conventional Carotid Artery Stenting group (control). Remote limb ischemic preconditioning (RIPC) is consisted of five 5-min cycles of bilateral arm ischemia/reperfusion, it is induced by an automated cuff-inflator placed on bilateral arm and inflated to 200 mmHg for 5-min followed by deflating the cuff for 5-min, patients in the RIPC group will do it twice a day for at least two weeks before carotid artery stenting. Patients in the sham RIPC group receive sham RIPC treatment, which is consisted of five 5-min cycles of bilateral arm ischemia/reperfusion, induced by an automated cuff-inflator placed on bilateral arm and inflated to 60 mmHg for 5-min followed by deflating the cuff for 5-min, they will do it twice a day for at least two weeks before carotid artery stenting. Patients in the control group receive conventional carotid artery stenting without RIPC or sham RIPC treatment. Cerebral injury is assessed by serum S-100B and Neuron specific enolase (NSE), systematic inflammation is assessed by serum high-sensitivity C-reactive protein (hs-CRP). Post-treatment infarctions, both symptomatic and asymptomatic, are detected by diffusion-weighted imaging (DWI) and clinical outcomes are determined by cerebrovascular events, cardiac events or death.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RIPC group | Experimental | Treatment:Patients in this group received standard medical therapy and remote ischemic preconditioning (RIPC) treatment. Device:RIPC consisted of five 5-min cycles of bilateral arm ischemia/reperfusion, which is induced by an automated cuff-inflator placed on bilateral arm and inflated to 200 mmHg for 5-min followed by deflating the cuff for 5-min,each patient in the RIPC group do it twice a day for at least two weeks before carotid artery stenting. Procedure: Carotid Artery Stenting |
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| Control group | Active Comparator | Treatment:Patients in this group received standard medical therapy alone. Procedure: Carotid Artery Stenting |
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| Sham RIPC group | Sham Comparator | Treatment:Patients in this group received standard medical therapy and sham remote ischemic preconditioning treatment. Device:Sham RIPC consisted of five 5-min cycles of bilateral arm ischemia/reperfusion, which is induced by an automated cuff-inflator placed on bilateral arm and inflated to 60 mmHg for 5-min followed by deflating the cuff for 5-min, each patient in RIPC group do it twice a day for at least two weeks before carotid artery stenting. Procedure: Carotid Artery Stenting |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remote ischemic preconditioning | Procedure | Remote ischemic preconditioning consisted of five 5-min cycles of bilateral arm ischemia/reperfusion, which is induced by an automated cuff-inflator placed on bilateral arm and inflated to 200 mmHg for 5-min followed by deflating the cuff for 5-min. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Cerebrovascular Events, Cardiovascular Events or Death. | Cerebrovascular events included ischemic stroke, transient ischemic attack (TIA), cerebral hemorrhage and hyperperfusion syndrome. Cardiovascular events included angina and myocardial infarction.Death included any reason caused death. | Within six months after carotid artery stenting |
| Participants Who Got New Diffusion-weighted Imaging (DWI) Lesions on Post-treatment Magnetic Resonance Imaging (MRI) Scans. | Within 48 hours after carotid artery stenting. |
| Measure | Description | Time Frame |
|---|---|---|
| Serum High-sensitive C-reactive Protein (Hs-CRP). | Baseline, on admission, and 1 and 24 hours after carotid artery stenting. | |
| Number of Patients With Any Side Effects of Remote Ischemic Preconditioning (RIPC) Treatment. | The side effects referred to any side effects of RIPC or sham RIPC treatment, not including the sides effect of medications and CAS. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Xunming Ji M.D., Ph.D. | Capital Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baojun Hou | Beijing | Beijing Municipality | 100053 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36645250 | Derived | Liang F, Liu S, Liu G, Liu H, Wang Q, Song B, Yao L. Remote ischaemic preconditioning versus no remote ischaemic preconditioning for vascular and endovascular surgical procedures. Cochrane Database Syst Rev. 2023 Jan 16;1(1):CD008472. doi: 10.1002/14651858.CD008472.pub3. | |
| 28174194 | Derived | Zhao W, Meng R, Ma C, Hou B, Jiao L, Zhu F, Wu W, Shi J, Duan Y, Zhang R, Zhang J, Sun Y, Zhang H, Ling F, Wang Y, Feng W, Ding Y, Ovbiagele B, Ji X. Safety and Efficacy of Remote Ischemic Preconditioning in Patients With Severe Carotid Artery Stenosis Before Carotid Artery Stenting: A Proof-of-Concept, Randomized Controlled Trial. Circulation. 2017 Apr 4;135(14):1325-1335. doi: 10.1161/CIRCULATIONAHA.116.024807. Epub 2017 Feb 7. |
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Symptomatic and asymptomatic subjects with carotid artery stenosis which was more than 70% by angiography , duplex ultrasound, Computed Tomography Angiography or Magnetic Resonance Angiography (NASCET criteria), who could undergo carotid artery stenting and all follow-ups, were recruited starting from August 2012.
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| ID | Title | Description |
|---|---|---|
| FG000 | RIPC Group | Treatment:Patients in this group received standard medical therapy and remote ischemic preconditioning (RIPC) treatment for at least 2 weeks before carotid artery stenting. Remote ischemic preconditioning: Remote ischemic preconditioning consisted of five 5-min cycles of bilateral arm ischemia/reperfusion, which is induced by an automated cuff-inflator placed on bilateral arm and inflated to 200 mmHg for 5-min followed by deflating the cuff for 5-min. Carotid Artery Stenting: Carotid Artery Stenting is an invasive therapy of carotid artery stenosis. |
| FG001 | Control Group | Treatment:Patients in this group received standard medical therapy alone for at least 2 weeks before carotid artery stenting. Carotid Artery Stenting: Carotid Artery Stenting is an invasive therapy of carotid artery stenosis. |
| FG002 | Sham RIPC Group | Treatment:Patients in this group received standard medical therapy and sham RIPC treatment for at least 2 weeks before carotid artery stenting. Sham remote ischemic preconditioning: Sham remote ischemic preconditioning consisted of five 5-min cycles of bilateral arm ischemia/reperfusion, which is induced by an automated cuff-inflator placed on bilateral arm and inflated to 60 mmHg for 5-min followed by deflating the cuff for 5-min. Carotid Artery Stenting: Carotid Artery Stenting is an invasive therapy of carotid artery stenosis. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Baseline Analysis Population only included participants who finished carotid artery stenting, post-treatment MRI scans and blood drawn.
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| ID | Title | Description |
|---|---|---|
| BG000 | RIPC Group | Treatment:Patients in this group received standard medical therapy and remote ischemic preconditioning (RIPC) treatment for at least 2 weeks before carotid artery stenting. Remote ischemic preconditioning: Remote ischemic preconditioning consisted of five 5-min cycles of bilateral arm ischemia/reperfusion, which is induced by an automated cuff-inflator placed on bilateral arm and inflated to 200 mmHg for 5-min followed by deflating the cuff for 5-min. Carotid Artery Stenting: Carotid Artery Stenting is an invasive therapy of carotid artery stenosis. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Patients With Cerebrovascular Events, Cardiovascular Events or Death. | Cerebrovascular events included ischemic stroke, transient ischemic attack (TIA), cerebral hemorrhage and hyperperfusion syndrome. Cardiovascular events included angina and myocardial infarction.Death included any reason caused death. | The analysis population only included participants who fully completed the study. | Posted | Number | participants | Within six months after carotid artery stenting |
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Through 6 months post carotid artery stenting.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | RIPC Group | Treatment:Patients in this group received standard medical therapy and remote ischemic preconditioning (RIPC) treatment for at least 2 weeks before carotid artery stenting. Remote ischemic preconditioning: Remote ischemic preconditioning consisted of five 5-min cycles of bilateral arm ischemia/reperfusion, which is induced by an automated cuff-inflator placed on bilateral arm and inflated to 200 mmHg for 5-min followed by deflating the cuff for 5-min. Carotid Artery Stenting: Carotid Artery Stenting is an invasive therapy of carotid artery stenosis. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hyperperfusion Syndrome | Nervous system disorders | Non-systematic Assessment | The hyperperfusion syndrome is characterized by headache, focal motor seizures and intracerebral hemorrhage, it can be evidenced by head Computed Tomography, Magnetic Resonance Imaging, Electroencephalogram. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| At least one new lesion | Nervous system disorders | Non-systematic Assessment | Number of participant with new DWI lesions on post-treatment MRI scans |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Xunming Ji, M.D.,Ph.D | XuanWu Hospital, Capital Medical University | 8683198127 | jixunming@vip.163.com |
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| ID | Term |
|---|---|
| D016893 | Carotid Stenosis |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D002340 | Carotid Artery Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| Sham remote ischemic preconditioning | Procedure | Sham remote ischemic preconditioning consisted of five 5-min cycles of bilateral arm ischemia/reperfusion, which is induced by an automated cuff-inflator placed on bilateral arm and inflated to 60 mmHg for 5-min followed by deflating the cuff for 5-min. |
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| Carotid Artery Stenting | Procedure | Carotid Artery Stenting is an invasive therapy of carotid artery stenosis. |
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| From baseline to 6 months after treatment. |
| Serum Neuron Specific Enolase (NSE) Levels. | Baseline, on admission, and 1 and 24 hours after carotid artery stenting. |
| Serum S-100B Levels. | Baseline, on admission, and 1 and 24 hours after carotid artery stenting. |
| Withdrawal by Subject |
|
| BG001 | Control Group | Treatment:Patients in this group received standard medical therapy alone for at least 2 weeks before carotid artery stenting. Carotid Artery Stenting: Carotid Artery Stenting is an invasive therapy of carotid artery stenosis. |
| BG002 | Sham RIPC Group | Treatment:Patients in this group received standard medical therapy and sham RIPC treatment for at least 2 weeks before carotid artery stenting. Sham remote ischemic preconditioning: Sham remote ischemic preconditioning consisted of five 5-min cycles of bilateral arm ischemia/reperfusion, which is induced by an automated cuff-inflator placed on bilateral arm and inflated to 60 mmHg for 5-min followed by deflating the cuff for 5-min. Carotid Artery Stenting: Carotid Artery Stenting is an invasive therapy of carotid artery stenosis. |
| BG003 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | participants |
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| Pre-treatment scans | Number | participants |
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| Clinical manifestation | Clinical manifestation of the target carotid artery stenosis. | Number | participants |
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| Contralateral carotid condition | Number | participants |
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| OG001 | Control Group | Treatment:Patients in this group received standard medical therapy alone for at least 2 weeks before carotid artery stenting. Carotid Artery Stenting: Carotid Artery Stenting is an invasive therapy of carotid artery stenosis. |
| OG002 | Sham RIPC Group | Treatment:Patients in this group received standard medical therapy and sham RIPC treatment for at least 2 weeks before carotid artery stenting. Sham remote ischemic preconditioning: Sham remote ischemic preconditioning consisted of five 5-min cycles of bilateral arm ischemia/reperfusion, which is induced by an automated cuff-inflator placed on bilateral arm and inflated to 60 mmHg for 5-min followed by deflating the cuff for 5-min. Carotid Artery Stenting: Carotid Artery Stenting is an invasive therapy of carotid artery stenosis. |
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| Primary | Participants Who Got New Diffusion-weighted Imaging (DWI) Lesions on Post-treatment Magnetic Resonance Imaging (MRI) Scans. | The analysed population only included participants who finished carotid artery stenting, post-treatment MRI scans and blood drawn. | Posted | Number | participants | Within 48 hours after carotid artery stenting. |
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| Secondary | Serum High-sensitive C-reactive Protein (Hs-CRP). | The analysed population only included participants who finished carotid artery stenting, post-treatment MRI scans and blood drawn. | Posted | Median | Inter-Quartile Range | mg/L | Baseline, on admission, and 1 and 24 hours after carotid artery stenting. |
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| Secondary | Number of Patients With Any Side Effects of Remote Ischemic Preconditioning (RIPC) Treatment. | The side effects referred to any side effects of RIPC or sham RIPC treatment, not including the sides effect of medications and CAS. | Posted | Number | participants | From baseline to 6 months after treatment. |
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| Secondary | Serum Neuron Specific Enolase (NSE) Levels. | The analysed population only included participants who finished carotid artery stenting, post-treatment MRI scans and blood drawn. | Posted | Mean | Standard Deviation | ng/L | Baseline, on admission, and 1 and 24 hours after carotid artery stenting. |
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| Secondary | Serum S-100B Levels. | The analysed population only included participants who finished carotid artery stenting, post-treatment MRI scans and blood drawn. | Posted | Mean | Standard Deviation | pg/mL | Baseline, on admission, and 1 and 24 hours after carotid artery stenting. |
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| 1 |
| 52 |
| 10 |
| 52 |
| EG001 | Control Group | Treatment:Patients in this group received standard medical therapy alone for at least 2 weeks before carotid artery stenting. Carotid Artery Stenting: Carotid Artery Stenting is an invasive therapy of carotid artery stenosis. | 3 | 56 | 26 | 56 |
| EG002 | Sham RIPC Group | Treatment:Patients in this group received standard medical therapy and sham RIPC treatment for at least 2 weeks before carotid artery stenting. Sham remote ischemic preconditioning: Sham remote ischemic preconditioning consisted of five 5-min cycles of bilateral arm ischemia/reperfusion, which is induced by an automated cuff-inflator placed on bilateral arm and inflated to 60 mmHg for 5-min followed by deflating the cuff for 5-min. Carotid Artery Stenting: Carotid Artery Stenting is an invasive therapy of carotid artery stenosis. | 3 | 54 | 23 | 54 |
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| Symptomatic Ischemic Stroke | Nervous system disorders | Non-systematic Assessment | Symptomatic ischemic stroke is defined as an acute neurological event lasting over 24 hours with focal signs and symptoms |
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| Transient Ischemic Attack | Nervous system disorders | Non-systematic Assessment | Transient ischemic attack (TIA) is a brief episode (<24 hours) of neurologic dysfunction resulting from focal temporary cerebral ischemia not associated with cerebral infarction. |
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| D009422 | Nervous System Diseases |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| 1 hour after CAS |
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| 24 hours after CAS |
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| 1 hour after CAS |
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| 24 hours after CAS |
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| 1 hour after CAS |
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| 24 hours after CAS |
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