The Effect Of Remote Limb Ischemic Preconditioning For Carotid Artery Stenting

Phase 1

• Conditions: Stroke; TIA; Coronary Stenosis
• Interventions: Device: remote limb ischemic preconditioning; Procedure: Carotid Artery Stenting

• Registration Number: NCT01175876
• Lead Sponsor: Capital Medical University

Brief Summary

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.

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.

Study Timeline

• Study Start: 2010-07
• Status Verified: 2010-08
• Study First Submitted: 2010-08-03
• Study First Submitted QC: 2010-08-04
• Study First Posted: 2010-08-05
• Last Update Submitted: 2010-08-05
• Last Update Posted: 2010-08-06
• Primary Completion: 2010-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Patients referred for elective Carotid Artery Stenting were participate in the study at the time of scheduling for operation.

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	remote limb ischemic preconditioning	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
1	Carotid Artery Stenting	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
2	Carotid Artery Stenting	Procedure: Carotid Artery Stenting

Primary Outcome Measures

Name	Time	Method
cognitive disorder assessment	2 days	1.The Mini-Mental State Examination( MMSE) test: The difference in MMSE score among patients treated with preconditioning and those not treated.
serum biomarkers	2 days	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	2DAYS	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.

Secondary Outcome Measures

Name	Time	Method
composite endpoint of any stroke,MI,or death	3months	The composite endpoint of any stroke ,MI, or death at 30-day and 90-day after the procedure.

Trial Locations

Locations (1)

Yumin Luo; 🇨🇳 Beijing, Beijing, China