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The Effect Of Remote Limb Ischemic Preconditioning For Carotid Artery Stenting

Primary Purpose

Stroke, TIA, Coronary Stenosis

Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
remote limb ischemic preconditioning
Carotid Artery Stenting
Sponsored by
Capital Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring MMSE, NSE, S100B, hsCRP, DWI-MRI

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Yumin LuoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

1

2

Arm Description

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

Procedure: Carotid Artery Stenting

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

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.

Full Information

First Posted
August 3, 2010
Last Updated
August 5, 2010
Sponsor
Capital Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT01175876
Brief Title
The Effect Of Remote Limb Ischemic Preconditioning For Carotid Artery Stenting
Official Title
The Effect Of Remote Limb Ischemic Preconditioning For Carotid Artery Stenting
Study Type
Interventional

2. Study Status

Record Verification Date
August 2010
Overall Recruitment Status
Unknown status
Study Start Date
July 2010 (undefined)
Primary Completion Date
December 2010 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Capital Medical University

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, TIA, Coronary Stenosis
Keywords
MMSE, NSE, S100B, hsCRP, DWI-MRI

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
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
Arm Title
2
Arm Type
Sham Comparator
Arm Description
Procedure: Carotid Artery Stenting
Intervention Type
Device
Intervention Name(s)
remote limb ischemic preconditioning
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
Carotid Artery Stenting
Intervention Description
Carotid Artery Stenting is an invasive therapy of carotid stenosis.
Primary Outcome Measure Information:
Title
cognitive disorder assessment
Description
1.The Mini-Mental State Examination( MMSE) test: The difference in MMSE score among patients treated with preconditioning and those not treated.
Time Frame
2 days
Title
serum biomarkers
Description
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.
Time Frame
2 days
Title
new brain lesions
Description
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.
Time Frame
2DAYS
Secondary Outcome Measure Information:
Title
composite endpoint of any stroke,MI,or death
Description
The composite endpoint of any stroke ,MI, or death at 30-day and 90-day after the procedure.
Time Frame
3months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:Patients referred for elective Carotid Artery Stenting were participate in the study at the time of scheduling for operation. 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. 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) Appropriate for carotid stenting. Candidates for Carotid Artery Stenting meet all other inclusion requirements. Exclusion Criteria: Evolving stroke Untoward reaction to anesthesia Intolerance or allergic reaction to associated medications, including aspirin(ASA) and clopidogrel. Prior major ipsilateral stroke that may confound study endpoints. Severe dementia. Hemorrhagic transformation of an ischemic stroke within the past 60 days. Chronic atrial fibrillation. MI within previous 30 days. High risk surgical candidate defined as the CREST test. Bilateral upper limb arteries are severe stenotic or occlusion.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xunming Ji Ji, M.D.,Ph.D.
Phone
8683198127
Email
jixm70@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xunming Ji, M.D.,Ph.D.
Organizational Affiliation
Proffessor
Official's Role
Study Chair
Facility Information:
Facility Name
Yumin Luo
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100053
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yumin Luo, M.D.,Ph.D.
Phone
8683198129
Email
yumin111@ccmu.edu.cn

12. IPD Sharing Statement

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The Effect Of Remote Limb Ischemic Preconditioning For Carotid Artery Stenting

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