The Effect Of Remote Limb Ischemic Preconditioning For Carotid Artery Stenting

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2010 by Capital Medical University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Capital Medical University
ClinicalTrials.gov Identifier:
NCT01175876
First received: August 3, 2010
Last updated: August 5, 2010
Last verified: August 2010
  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

Resource links provided by NLM:


Further study details as provided by Capital Medical University:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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
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.

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
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

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:
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 August 01, 2014