Bilateral Limb Ischemic Preconditioning, Intracranial Arterial Stenosis
Conditions
Keywords
remote ischemic preconditioning, octogenarian, intracranial arterial stenosis, stroke recurrence
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.
Interventions
DEVICEbilateral limb ischemic preconditioning (Doctormate, IPC-906X)
Device: bilateral limb ischemic preconditioning (Doctormate, IPC-906X, produced by Beijing Renqiao Institute of Neuroscience)five cycles of 5 minutes bilateral upper limb ischemia-reperfusion performed by inflating tourniquets to 200 mmHg, twice daily for 180 consecutive days, along with conventional medical treatment.
Sponsors
Ji Xunming
Capital Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
80 Years to 95 Years
Healthy volunteers
No
Inclusion criteria
1. age between 80 to 95 years old 2. Trial of Org 10172 in Acute Stroke Treatment-1 (TOAST-1) subtype 3. National Institutes of Health Stroke Scale (NIHSS) score 0-15, and Modified Rankin Scale (mRS) score 0-4 4. ABCD2 score between 6 to 7 5. stable vital signs, normal hepatic and renal functions 6. no hemorrhagic tendencies
Exclusion criteria
1. within 72 hrs of intra-artery or intravenous thrombolysis 2. intracranial hemorrhage or large area of cerebral infarction (more than 1/3 middle cerebral artery perfusion territory) 3. any soft tissue, orthopedic, or vascular injury, wounds or fractures in extremities which may pose a contraindication for application of the preconditioning cuffs 4. acute myocardial infarction 5. systolic blood pressure more than 200 mmHg after drug control 6. peripheral blood vessel disease 7. hematologic disease 8. severe hepatic and renal dysfunction 9. severe or unstable concomitant disease 10. cannot tolerate BLIPC or without informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| objective signs of tissue or neurovascular injury | 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 | 180-day | levels of plasma myoglobin at baseline and at the 1st, 15th and 30th day during BLIPC treatment were monitored |
Countries
China
Outcome results
None listed