The Effect Of Remote Limb Ischemic Preconditioning For Carotid Artery Stenting

Stroke Clinical Trial

Official title:

The Effect Of Remote Limb Ischemic Preconditioning For Carotid Artery Stenting

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT01175876
• Other study ID #: RIPC2010
• Status: Unknown status
• Phase: Phase 1
• First received: August 3, 2010
• Last updated: August 5, 2010
• Start date: July 2010

Study information

• Verified date: August 2010
• Source: Capital Medical University
• Contact: Xunming Ji Ji, M.D.,Ph.D.
• Phone: 8683198127
• Email: jixm70[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 60
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Stenosis
• Stroke
• TIA

Intervention

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.

Locations

Country	Name	City	State
China	Yumin Luo	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Capital Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cognitive disorder assessment	1.The Mini-Mental State Examination( MMSE) test: The difference in MMSE score among patients treated with preconditioning and those not treated.	2 days
Primary	serum biomarkers	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.	2 days
Primary	new brain lesions	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.	2DAYS
Secondary	composite endpoint of any stroke,MI,or death	The composite endpoint of any stroke ,MI, or death at 30-day and 90-day after the procedure.	3months