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The Effect Of Remote Limb Ischemic Preconditioning For Carotid Artery Stenting

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ClinicalTrials.gov Identifier: NCT01175876
Recruitment Status : Unknown
Verified August 2010 by Capital Medical University.
Recruitment status was:  Recruiting
First Posted : August 5, 2010
Last Update Posted : August 6, 2010
Sponsor:
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment Phase
Stroke TIA Coronary Stenosis Device: remote limb ischemic preconditioning Procedure: Carotid Artery Stenting Phase 1

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Treatment
Official Title: The Effect Of Remote Limb Ischemic Preconditioning For Carotid Artery Stenting
Study Start Date : July 2010
Estimated Primary Completion Date : December 2010
Arms and Interventions

Arm Intervention/treatment
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
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.
Sham Comparator: 2
Procedure: Carotid Artery Stenting
Procedure: Carotid Artery Stenting
Carotid Artery Stenting is an invasive therapy of carotid stenosis.


Outcome Measures

Primary Outcome Measures :
  1. cognitive disorder assessment [ Time Frame: 2 days ]
    1.The Mini-Mental State Examination( MMSE) test: The difference in MMSE score among patients treated with preconditioning and those not treated.

  2. serum biomarkers [ Time Frame: 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.

  3. new brain lesions [ Time Frame: 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 :
  1. composite endpoint of any stroke,MI,or death [ Time Frame: 3months ]
    The composite endpoint of any stroke ,MI, or death at 30-day and 90-day after the procedure.


Eligibility Criteria

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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01175876


Contacts
Contact: Xunming Ji Ji, M.D.,Ph.D. 8683198127 jixm70@hotmail.com

Locations
China, Beijing
Yumin Luo Recruiting
Beijing, Beijing, China, 100053
Contact: Yumin Luo, M.D.,Ph.D.    8683198129    yumin111@ccmu.edu.cn   
Sponsors and Collaborators
Capital Medical University
Investigators
Study Chair: Xunming Ji, M.D.,Ph.D. Proffessor
More Information

Responsible Party: Xunming Ji, XuanWu Hospital,Capital medical University
ClinicalTrials.gov Identifier: NCT01175876     History of Changes
Other Study ID Numbers: RIPC2010
First Posted: August 5, 2010    Key Record Dates
Last Update Posted: August 6, 2010
Last Verified: August 2010

Keywords provided by Capital Medical University:
MMSE
NSE
S100B
hsCRP
DWI-MRI

Additional relevant MeSH terms:
Coronary Stenosis
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases