Protective Effects of Long-term Remote Limb Ischemic Preconditioning For Carotid Artery Stenting

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2015 by Capital Medical University
Sponsor:
Information provided by (Responsible Party):
Ji Xunming, Capital Medical University
ClinicalTrials.gov Identifier:
NCT01654666
First received: July 23, 2012
Last updated: June 16, 2015
Last verified: June 2015
  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 remote ischemic preconditioning
Procedure: Carotid Artery Stenting
Behavioral: Control of risk factors and standard medical therapy
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

Further study details as provided by Capital Medical University:

Primary Outcome Measures:
  • Number of patients with cerebrovascular events, cardiovascular events or death. [ Time Frame: Within six months after carotid artery stenting ] [ Designated as safety issue: Yes ]
  • The percentages of participants who get new diffusion-weighted imaging lesions on post-treatment MRI scans. [ Time Frame: Within 48 hours after carotid artery stenting. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Serum biomarkers of inflammation and brain injury. [ Time Frame: Baselin, on admission, and 1 and 24 hours after carotid artery stenting. ] [ Designated as safety issue: Yes ]
  • Number of patients with any side effects of RIPC treatment. [ Time Frame: From baseline to 6 month after treatment. ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 150
Study Start Date: June 2012
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: RIPC group

Treatment:Patients in this group received standard medical therapy and remote ischemic preconditioning (RIPC) treatment.

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 at least 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: RIPC
Procedure: Carotid Artery Stenting
Carotid Artery Stenting is an invasive therapy of carotid stenosis.
Other Name: CAS
Behavioral: Control of risk factors and standard medical therapy
Recognition and control of the modifiable risk factors for stroke. Besides behavior change, antiplatelet agents, antihypertensive agents, antidiabetic agents and statins were admitted if necessary.
Active Comparator: Control group
Treatment:Patients in this group received standard medical therapy alone. Procedure: Carotid Artery Stenting
Procedure: Carotid Artery Stenting
Carotid Artery Stenting is an invasive therapy of carotid stenosis.
Other Name: CAS
Behavioral: Control of risk factors and standard medical therapy
Recognition and control of the modifiable risk factors for stroke. Besides behavior change, antiplatelet agents, antihypertensive agents, antidiabetic agents and statins were admitted if necessary.
Sham Comparator: Sham RIPC group

Treatment:Patients in this group received standard medical therapy and sham RIPC treatment.

Device: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 60 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 remote 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 60 mmHg for 5mins followed by deflating the cuff for 5mins.
Other Name: Sham RIPC
Procedure: Carotid Artery Stenting
Carotid Artery Stenting is an invasive therapy of carotid stenosis.
Other Name: CAS
Behavioral: Control of risk factors and standard medical therapy
Recognition and control of the modifiable risk factors for stroke. Besides behavior change, antiplatelet agents, antihypertensive agents, antidiabetic agents and statins were admitted if necessary.

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 prospective randomized controlled trial will be performed in the current study.

DESIGNING about 150 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 at least 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 60 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 serum S-100b and NSE, systematic inflammation was assessed by serum hs-CRP. Post-treatment infarctions, both symptomatic and asymptomatic, were detected by diffusion-weighted imaging and clinical outcomes were determined by cerebral events, cardiac events or death.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Tolerance to any of the study medications, including clopidogrel, aspirin and statins;
  2. Can cooperate with and complete brain MRI examination;
  3. Has a negative pregnancy test within 7 days before randomization and no childbearing potential;
  4. Vascular ultrasound excluded intravascular thrombosis and unstable plaques in blood vessels of the bilateral upper limbs;
  5. No hemorrhagic tendency;
  6. Stable vital sign, normal renal and hepatic functions;
  7. Informed consent.

Exclusion Criteria:

  1. Evolving stroke;
  2. Prior major ipsilateral stroke, if likely to confound study endpoints;
  3. Severe dementia;
  4. Hemorrhagic conversion of an ischemic stroke within the past 60 days;
  5. Chronic atrial fibrillation;
  6. Myocardial infarction within previous 30 days;
  7. Inability to understand and cooperate with study procedures or provide informed consent;
  8. participating in other device or drug trial that has not completed the required protocol follow-up period;
  9. Any conditions that hampers proper angiographic assessment or makes percutaneous arterial access unsafe;
  10. High risk candidates defined as the Carotid Revascularization Endarterectomy vs. Stenting Trial (CREST)26;
  11. Any vascular, extremity soft tissue or orthopedic injury that may contraindicate bilateral arm ischemic preconditioning (e.g. superficial wounds and fractures of the arm);
  12. Blood pressure cannot be controlled lower than 200 mmHg by medications;
  13. Peripheral blood vessel disease (especially subclavian arterial and upper limb artery stenosis 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, 100053
Contact: baojun HOU, M.D    8683198129    bestjunren2008@126.com   
Contact: Wenbo Zhao, M.D    +86 15810766407    zhaowb.cool@163.com   
Principal Investigator: Wenbo Zhao, M.D         
Principal Investigator: Baojun Hou, M.D         
Principal Investigator: Xunming Ji, M.D,Ph.D         
Principal Investigator: Ran Meng, M.D         
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: June 16, 2015
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:
Ischemia
Ischemic Attack, Transient
Brain Diseases
Brain Ischemia
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Nervous System Diseases
Pathologic Processes
Vascular Diseases

ClinicalTrials.gov processed this record on August 27, 2015