The Effect Of Remote Limb Ischemic Preconditioning For Carotid Artery Stenting

August 5, 2010 updated by: Capital Medical University
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100053
        • Recruiting
        • Yumin Luo
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 days
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.
2 days
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.
2DAYS

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Capital Medical University

Investigators

  • Study Chair: Xunming Ji, M.D.,Ph.D., Proffessor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2010

Primary Completion (Anticipated)

December 1, 2010

Study Registration Dates

First Submitted

August 3, 2010

First Submitted That Met QC Criteria

August 4, 2010

First Posted (Estimate)

August 5, 2010

Study Record Updates

Last Update Posted (Estimate)

August 6, 2010

Last Update Submitted That Met QC Criteria

August 5, 2010

Last Verified

August 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RIPC2010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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