Protective Effects of Long-term Remote Limb Ischemic Preconditioning For Carotid Artery Stenting
Condition: Carotid Artery Stenosis
MeSH terms: Carotid Stenosis
Intervention: Remote ischemic preconditioning; Sham remote ischemic preconditioning; Carotid Artery Stenting
Intervention description: Remote ischemic preconditioning consisted of five 5-min cycles of bilateral arm ischemia/reperfusion, which is induced by an automated cuff-inflator placed on bilateral arm and inflated to 200 mmHg for 5-min followed by deflating the cuff for 5-min.; Sham remote ischemic preconditioning consisted of five 5-min cycles of bilateral arm ischemia/reperfusion, which is induced by an automated cuff-inflator placed on bilateral arm and inflated to 60 mmHg for 5-min followed by deflating the cuff for 5-min.; Carotid Artery Stenting is an invasive therapy of carotid artery stenosis.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Enrollment: 189.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Remote ischemic preconditioning; Stroke secondary prevention; Carotid artery stenting; Carotid stenosis; Inflammation

Summary:

      Remote limb ischemic preconditioning (RIPC) has neuro-protective and anti-inflammatory
      effects on ischemia- reperfusion injury. As the extent of its effect is unknown, the
      investigators will use clinical outcome, serum biochemical markers and brain magnetic
      resonance imaging (MRI) to determine whether RIPC has neuro-protective and anti-inflammatory
      effects on patients undergoing carotid artery stenting.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Symptomatic or asymptomatic carotid artery stenosis. In symptomatic patients the
             degree of stenosis should more than 60% (Based on NASCET Criteria), in asymptomatic
             patients the degree of stenosis should more than 70% (Based on NASCET Criteria);

          2. Tolerance to any of the study medications, including clopidogrel, aspirin and statins;

          3. Can cooperate with and complete brain MRI examination;

          4. Has a negative pregnancy test within 7 days before randomization and no childbearing
             potential;

          5. Vascular ultrasound excluded intravascular thrombosis and unstable plaques in blood
             vessels of the bilateral upper limbs;

          6. No hemorrhagic tendency;

          7. Stable vital sign, normal renal and hepatic functions;

          8. 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);

         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).