Protective Effects of Long-term Remote Limb Ischemic Preconditioning For Carotid Artery Stenting

Completed

Phase 2 Results

Update History

17 Nov '15
The Summary of Purpose was updated.
New
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.
Old
Remote limb ischemic preconditioning (RIPC) is neuro-protective and anti-inflammatory for ischemia- reperfusion injury. As the extent of its effect is unknown, the investigators will use clinical outcome, serum biochemical markers and diffusion-weighted magnetic resonance imaging (DW-MRI)to determine the neuro-protective and anti-inflammatory of Long-term Remote limb ischemic preconditioning.
The description was updated.
New
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.
Old
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 from 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 perioperative and long-term complications, a prospective randomized controlled trial will be performed in the current study. DESIGNING about 150 patients will be randomized to Carotid Artery Stenting with RIPC group,sham RIPC group and conventional Carotid Artery Stenting group (control). Remote limb ischemic preconditioning (RIPC) consisted of five 5-min cycles of right upper arm ischemia/reperfusion, which was induced by an automated cuff-inflator placed on the right upper arm which was inflated to 200 mmHg for 5mins followed by deflating the cuff for 5mins, each RIPC group patients did it twice a day for at least two weeks,sham RIPC group patients received sham RIPC, consisted of five 5-min cycles of right upper arm ischemia/reperfusion, which was induced by an automated cuff-inflator placed on the right upper arm which was inflated to 60 mmHg for 5mins followed by deflating the cuff for 5mins, each sham RIPC group patients did it twice a day for two weeks. The control group patients received conventional Carotid Artery Stenting without RIPC.Cerebral injury was assessed by serum S-100b and NSE, systematic inflammation was assessed by serum hs-CRP. Post-treatment infarctions, both symptomatic and asymptomatic, were detected by diffusion-weighted imaging and clinical outcomes were determined by cerebral events, cardiac events or death.
The eligibility criteria were updated.
New
Inclusion Criteria: 1. Symptomatic or asymptomatic carotid artery stenosis. In symptomatic patients the degree of stenosis should more than 60% (Based on NASCET Criteria), in asymptomatic patients the degree of stenosis should more than 70% (Based on NASCET Criteria); 2. Tolerance to any of the study medications, including clopidogrel, aspirin and statins; 3. Can cooperate with and complete brain MRI examination; 4. Has a negative pregnancy test within 7 days before randomization and no childbearing potential; 5. Vascular ultrasound excluded intravascular thrombosis and unstable plaques in blood vessels of the bilateral upper limbs; 6. No hemorrhagic tendency; 7. Stable vital sign, normal renal and hepatic functions; 8. Informed consent. Exclusion Criteria: 1. Evolving stroke; 2. Prior major ipsilateral stroke, if likely to confound study endpoints; 3. Severe dementia; 4. Hemorrhagic conversion of an ischemic stroke within the past 60 days; 5. Chronic atrial fibrillation; 6. Myocardial infarction within previous 30 days; 7. Inability to understand and cooperate with study procedures or provide informed consent; 8. Participating in other device or drug trial that has not completed the required protocol follow-up period; 9. Any conditions that hampers proper angiographic assessment or makes percutaneous arterial access unsafe; 10. High risk candidates defined as the Carotid Revascularization Endarterectomy vs. Stenting Trial (CREST); 11. Any vascular, extremity soft tissue or orthopedic injury that may contraindicate bilateral arm ischemic preconditioning (e.g. superficial wounds and fractures of the arm); 12. Blood pressure cannot be controlled lower than 200 mmHg by medications; 13. Peripheral blood vessel disease (especially subclavian arterial and upper limb artery stenosis or occlusion).
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Inclusion Criteria: 1. Tolerance to any of the study medications, including clopidogrel, aspirin and statins; 2. Can cooperate with and complete brain MRI examination; 3. Has a negative pregnancy test within 7 days before randomization and no childbearing potential; 4. Vascular ultrasound excluded intravascular thrombosis and unstable plaques in blood vessels of the bilateral upper limbs; 5. No hemorrhagic tendency; 6. Stable vital sign, normal renal and hepatic functions; 7. Informed consent. Exclusion Criteria: 1. Evolving stroke; 2. Prior major ipsilateral stroke, if likely to confound study endpoints; 3. Severe dementia; 4. Hemorrhagic conversion of an ischemic stroke within the past 60 days; 5. Chronic atrial fibrillation; 6. Myocardial infarction within previous 30 days; 7. Inability to understand and cooperate with study procedures or provide informed consent; 8. participating in other device or drug trial that has not completed the required protocol follow-up period; 9. Any conditions that hampers proper angiographic assessment or makes percutaneous arterial access unsafe; 10. High risk candidates defined as the Carotid Revascularization Endarterectomy vs. Stenting Trial (CREST)26; 11. Any vascular, extremity soft tissue or orthopedic injury that may contraindicate bilateral arm ischemic preconditioning (e.g. superficial wounds and fractures of the arm); 12. Blood pressure cannot be controlled lower than 200 mmHg by medications; 13. Peripheral blood vessel disease (especially subclavian arterial and upper limb artery stenosis or occlusion).
A location was updated in Beijing.
New
The overall status was removed for baojun Hou.
18 Jun '15
The description was updated.
New
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 from 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 perioperative and long-term complications, a prospective randomized controlled trial will be performed in the current study. DESIGNING about 150 patients will be randomized to Carotid Artery Stenting with RIPC group,sham RIPC group and conventional Carotid Artery Stenting group (control). Remote limb ischemic preconditioning (RIPC) consisted of five 5-min cycles of right upper arm ischemia/reperfusion, which was induced by an automated cuff-inflator placed on the right upper arm which was inflated to 200 mmHg for 5mins followed by deflating the cuff for 5mins, each RIPC group patients did it twice a day for at least two weeks,sham RIPC group patients received sham RIPC, consisted of five 5-min cycles of right upper arm ischemia/reperfusion, which was induced by an automated cuff-inflator placed on the right upper arm which was inflated to 60 mmHg for 5mins followed by deflating the cuff for 5mins, each sham RIPC group patients did it twice a day for two weeks. The control group patients received conventional Carotid Artery Stenting without RIPC.Cerebral injury was assessed by serum S-100b and NSE, systematic inflammation was assessed by serum hs-CRP. Post-treatment infarctions, both symptomatic and asymptomatic, were detected by diffusion-weighted imaging and clinical outcomes were determined by cerebral events, cardiac events or death.
Old
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 from 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 perioperative and long-term complications, a randomized controlled trial will be performed in the current study. DESIGNING about 90 patients will be randomized to Carotid Artery Stenting with RIPC group,sham RIPC group and conventional Carotid Artery Stenting group (control). Remote limb ischemic preconditioning (RIPC) consisted of five 5-min cycles of right upper arm ischemia/reperfusion, which was induced by an automated cuff-inflator placed on the right upper arm which was inflated to 200 mmHg for 5mins followed by deflating the cuff for 5mins, each RIPC group patients did it twice a day for two weeks,sham RIPC group patients received sham RIPC, consisted of five 5-min cycles of right upper arm ischemia/reperfusion, which was induced by an automated cuff-inflator placed on the right upper arm which was inflated to 20 mmHg for 5mins followed by deflating the cuff for 5mins, each sham RIPC group patients did it twice a day for two weeks. The control group patients received conventional Carotid Artery Stenting without RIPC. Cerebral injury was assessed by S-100b, NSE, hs-CRP and MMSE test in different time points.
The minimum age criteria for eligibility was updated to "18 Years."
The eligibility criteria were updated.
New
Inclusion Criteria: 1. Tolerance to any of the study medications, including clopidogrel, aspirin and statins; 2. Can cooperate with and complete brain MRI examination; 3. Has a negative pregnancy test within 7 days before randomization and no childbearing potential; 4. Vascular ultrasound excluded intravascular thrombosis and unstable plaques in blood vessels of the bilateral upper limbs; 5. No hemorrhagic tendency; 6. Stable vital sign, normal renal and hepatic functions; 7. Informed consent. Exclusion Criteria: 1. Evolving stroke; 2. Prior major ipsilateral stroke, if likely to confound study endpoints; 3. Severe dementia; 4. Hemorrhagic conversion of an ischemic stroke within the past 60 days; 5. Chronic atrial fibrillation; 6. Myocardial infarction within previous 30 days; 7. Inability to understand and cooperate with study procedures or provide informed consent; 8. participating in other device or drug trial that has not completed the required protocol follow-up period; 9. Any conditions that hampers proper angiographic assessment or makes percutaneous arterial access unsafe; 10. High risk candidates defined as the Carotid Revascularization Endarterectomy vs. Stenting Trial (CREST)26; 11. Any vascular, extremity soft tissue or orthopedic injury that may contraindicate bilateral arm ischemic preconditioning (e.g. superficial wounds and fractures of the arm); 12. Blood pressure cannot be controlled lower than 200 mmHg by medications; 13. Peripheral blood vessel disease (especially subclavian arterial and upper limb artery stenosis or occlusion).
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Inclusion Criteria: 1. Symptomatic patient, as evidenced by transient ischemic attack (TIA), amaurosis fugax, minor or non-disabling stroke(in the hemisphere supplied by the target vessel), within 180 days of the randomization date. 2. Discrete lesion located in the internal carotid artery(ICA), and the degree of carotid stenosis ≥50% defined as:Stenosis ≥70% by ultrasound. Stenosis ≥50% by angiography (based on NASCET Criteria) 3. Appropriate for carotid stenting. Candidates for Carotid Artery Stenting meet all other inclusion requirements. Exclusion Criteria: 1. Evolving stroke 2. Untoward reaction to anesthesia 3. Intolerance or allergic reaction to associated medications, including aspirin(ASA) and clopidogrel. 4. Prior major ipsilateral stroke that may confound study endpoints. 5. Severe dementia. 6. Hemorrhagic transformation of an ischemic stroke within the past 60 days. 7. Chronic atrial fibrillation. 8. MI within previous 30 days. 9. High risk surgical candidate defined as the CREST test. 10. Bilateral upper limb arteries are severe stenotic or occlusion.