Feasibility, Safety and Efficacy of RIPC for Symptomatic Intracranial Arterial Stenosis in Octogenarians
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Bilateral Limb Ischemic Preconditioning
- Sponsor
- Ji Xunming
- Enrollment
- 58
- Locations
- 1
- Primary Endpoint
- objective signs of tissue or neurovascular injury
- Status
- Completed
- Last Updated
- 13 years ago
Overview
Brief Summary
Making a limb transiently ischemic induces ischemic tolerance in distant organs such as the heart. This study aims to evaluate the feasibility, safety and initial efficacy of using briefly repetitive bilateral limb ischemic preconditioning (BLIPC) to protect the brain in octogenarians with symptomatic intracranial arterial stenosis.
Investigators
Ji Xunming
Professor
Capital Medical University
Eligibility Criteria
Inclusion Criteria
- •age between 80 to 95 years old
- •Trial of Org 10172 in Acute Stroke Treatment-1 (TOAST-1) subtype
- •National Institutes of Health Stroke Scale (NIHSS) score 0-15, and Modified Rankin Scale (mRS) score 0-4
- •ABCD2 score between 6 to 7
- •stable vital signs, normal hepatic and renal functions
- •no hemorrhagic tendencies
Exclusion Criteria
- •within 72 hrs of intra-artery or intravenous thrombolysis
- •intracranial hemorrhage or large area of cerebral infarction (more than 1/3 middle cerebral artery perfusion territory)
- •any soft tissue, orthopedic, or vascular injury, wounds or fractures in extremities which may pose a contraindication for application of the preconditioning cuffs
- •acute myocardial infarction
- •systolic blood pressure more than 200 mmHg after drug control
- •peripheral blood vessel disease
- •hematologic disease
- •severe hepatic and renal dysfunction
- •severe or unstable concomitant disease
- •cannot tolerate BLIPC or without informed consent
Outcomes
Primary Outcomes
objective signs of tissue or neurovascular injury
Time Frame: 180 days after treatment
objective signs of tissue or neurovascular injury felt to be due to cuff inflation, which was based on the judgment of the observers (blinded to study protocol) precluded continuation. Inspection included palpation of distal radial pulses, visual inspection (for local edema, redness, skin breakdown), and palpation for tenderness
levels of plasma biomarkers
Time Frame: 180-day
levels of plasma myoglobin at baseline and at the 1st, 15th and 30th day during BLIPC treatment were monitored