The Effect Of Remote Limb Ischemic Preconditioning For Carotid Artery Stenting
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Purpose
Remote limb ischemic preconditioning 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 extent of its neuro-protective and anti-inflammatory effect.
| Condition | Intervention | Phase |
|---|---|---|
|
Stroke TIA Coronary Stenosis |
Device: remote limb ischemic preconditioning Procedure: Carotid Artery Stenting |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Caregiver) Primary Purpose: Treatment |
| Official Title: | The Effect Of Remote Limb Ischemic Preconditioning For Carotid Artery Stenting |
- cognitive disorder assessment [ Time Frame: 2 days ] [ Designated as safety issue: Yes ]1.The Mini-Mental State Examination( MMSE) test: The difference in MMSE score among patients treated with preconditioning and those not treated.
- serum biomarkers [ Time Frame: 2 days ] [ Designated as safety issue: Yes ]Serum biomarkers of brain injury and flammatory: The difference in NSE, S-100b and hs-CRP level among patients treated with preconditioning and those not treated.
- new brain lesions [ Time Frame: 2DAYS ] [ Designated as safety issue: Yes ]The new lesions at DWI-MRI within postoperation 48 hours: The difference in new lesions in the DWI-MRI 48 hours postoperatively among patients treated with preconditioning and those not treated.
- composite endpoint of any stroke,MI,or death [ Time Frame: 3months ] [ Designated as safety issue: Yes ]The composite endpoint of any stroke ,MI, or death at 30-day and 90-day after the procedure.
| Estimated Enrollment: | 60 |
| Study Start Date: | July 2010 |
| Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Device: RIPC 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 Procedure: Carotid Artery Stenting
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Device: remote limb ischemic preconditioning
Remote limb ischemic preconditioning 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
Procedure: Carotid Artery Stenting
Carotid Artery Stenting is an invasive therapy of carotid stenosis.
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Sham Comparator: 2
Procedure: Carotid Artery Stenting
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Procedure: Carotid Artery Stenting
Carotid Artery Stenting is an invasive therapy of carotid stenosis.
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Detailed Description:
BACKGROUND: Brain ischemia and injury contributed to perioperative morbidity and mortality in Carotid Artery Stenting. Remote ischemic preconditioning (RIPC) is a phenomenon whereby brief periods of ischemia followed by reperfusion in one organ provide systemic protection from prolonged ischemia. To investigate whether remote preconditioning protects the brain injury in patients undergoing elective Carotid Artery Stenting, a randomized trial will be performed in current study.
DESIGNING 60 patients will be randomized to Carotid Artery Stenting with RIPC group or conventional Carotid Artery Stenting group (control). 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. Cerebral injury was assessed by S-100b, NSE, hs-CRP and MMSE test in different time points.
Eligibility| Ages Eligible for Study: | 40 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:Patients referred for elective Carotid Artery Stenting were participate in the study at the time of scheduling for operation.
- 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.
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)
- Appropriate for carotid stenting. Candidates for Carotid Artery Stenting meet all other inclusion requirements.
Exclusion Criteria:
- Evolving stroke
- Untoward reaction to anesthesia
- Intolerance or allergic reaction to associated medications, including aspirin(ASA) and clopidogrel.
- Prior major ipsilateral stroke that may confound study endpoints.
- Severe dementia.
- Hemorrhagic transformation of an ischemic stroke within the past 60 days.
- Chronic atrial fibrillation.
- MI within previous 30 days.
- High risk surgical candidate defined as the CREST test.
- Bilateral upper limb arteries are severe stenotic or occlusion.
Contacts and Locations| Contact: Xunming Ji Ji, M.D.,Ph.D. | 8683198127 | jixm70@hotmail.com |
| China, Beijing | |
| Yumin Luo | Recruiting |
| Beijing, Beijing, China, 100053 | |
| Contact: Yumin Luo, M.D.,Ph.D. 8683198129 yumin111@ccmu.edu.cn | |
| Study Chair: | Xunming Ji, M.D.,Ph.D. | Proffessor |
More Information
No publications provided
| Responsible Party: | Xunming Ji, XuanWu Hospital，Capital medical University |
| ClinicalTrials.gov Identifier: | NCT01175876 History of Changes |
| Other Study ID Numbers: | RIPC2010 |
| Study First Received: | August 3, 2010 |
| Last Updated: | August 5, 2010 |
| Health Authority: | China: Food and Drug Administration |
Keywords provided by Capital Medical University:
|
MMSE NSE S100B hsCRP DWI-MRI |
Additional relevant MeSH terms:
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Stroke Coronary Stenosis Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Vascular Diseases Cardiovascular Diseases Coronary Disease Myocardial Ischemia Heart Diseases |
ClinicalTrials.gov processed this record on May 23, 2013