Protective Effects of Long-term 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 July 2012 by Capital Medical University.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Ji Xunming, Capital Medical University
ClinicalTrials.gov Identifier:
NCT01654666
First received: July 23, 2012
Last updated: July 28, 2012
Last verified: July 2012
  Purpose

Remote limb ischemic preconditioning (RIPC) 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 neuro-protective and anti-inflammatory of Long-term Remote limb ischemic preconditioning.


Condition Intervention Phase
Stroke
Transient Ischemic Attack
Procedure: remote limb ischemic preconditioning
Procedure: sham RIPC
Procedure: Carotid Artery Stenting
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Protective Effects of Long-term 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:
  • Composite measure of serum NSE, S-100b and Hs-CRP at baseline. [ Time Frame: Within 1 week before remote ischemic preconditiong and carotid artery stenting surgery. ] [ Designated as safety issue: Yes ]
  • Composite measure of serum NSE, S100-b and hs-CRP at 1hour after carotid artery stenting. [ Time Frame: Right 1hour after carotid artery stenting. ] [ Designated as safety issue: Yes ]
  • Composite measure of serum NSE, S100-b and hs-CRP at 24 hours after carotid artery stenting. [ Time Frame: 24 hours after carotid artery stenting. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • The Incidence of Brain or Cardiac Ischemic Events and Death [ Time Frame: six months after CAS ] [ Designated as safety issue: Yes ]
  • the Percentage of Participants Who Got New Brain Lesions After Carotid Artery Stenting (CAS) [ Time Frame: preoperation and 48 hours after operation ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 90
Study Start Date: June 2012
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: RIPC
Device: 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,each patient in RIPC group did it twice a day for two weeks. Procedure: Carotid Artery Stenting
Procedure: 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.
Other Name: remote limb ischemic preconditioning(RIPC)
Procedure: Carotid Artery Stenting
Carotid Artery Stenting is an invasive therapy of carotid stenosis
Sham Comparator: control
Procedure: asymptomatic patients undergoing Carotid Artery Stenting
Procedure: Carotid Artery Stenting
Carotid Artery Stenting is an invasive therapy of carotid stenosis
Placebo Comparator: sham 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 20 mmHg for 5mins followed by deflating the cuff for 5mins,each patient in RIPC group did it twice a day for two weeks. Procedure: Carotid Artery Stenting
Procedure: sham RIPC
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 20 mmHg for 5mins followed by deflating the cuff for 5mins.
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), brief periods of ischemia followed by reperfusion, can provide systemic protection from prolonged ischemia. Our previous study found no significant protection to the patients who received once RIPC before Carotid Artery Stenting. In order to investigate whether long-term RIPC before Carotid Artery Stenting can protect these patients from perioperative and long-term complications, a randomized controlled trial will be performed in the current study.

DESIGNING about 90 patients will be randomized to Carotid Artery Stenting with RIPC group,sham RIPC group and conventional Carotid Artery Stenting group (control). Remote limb ischemic preconditioning (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, each RIPC group patients did it twice a day for two weeks,sham RIPC group patients received sham 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 20 mmHg for 5mins followed by deflating the cuff for 5mins, each sham RIPC group patients did it twice a day for two weeks. The control group patients received conventional Carotid Artery Stenting without RIPC. 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:

  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: NCT01654666

Contacts
Contact: xunming ji M.D., Ph.D. 8683198127 jixm70@hotmail.com

Locations
China, Beijing
baojun Hou Recruiting
Beijing, Beijing, China
Contact: baojun HOU, M.D    8683198129    bestjunren2008@126.com   
Sponsors and Collaborators
Ji Xunming
Investigators
Principal Investigator: xunming ji M.D., Ph.D. Capital Medical University
  More Information

No publications provided

Responsible Party: Ji Xunming, XuanWu Hospital, Capital Medical University
ClinicalTrials.gov Identifier: NCT01654666     History of Changes
Other Study ID Numbers: RIPC2012
Study First Received: July 23, 2012
Last Updated: July 28, 2012
Health Authority: China: Food and Drug Administration

Keywords provided by Capital Medical University:
NSE
S100B
hsCRP
DWI-MRI
Remote Limb Ischemic Preconditioning
TIA

Additional relevant MeSH terms:
Ischemic Attack, Transient
Ischemia
Stroke
Brain Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on July 29, 2014