Optimized Remote Ischemic Conditioning (RIC) Treatment for Patients With Chronic Cerebral Ischemia

This is an interventional prevention trial for Chronic Cerebral Ischemia focused on measuring Intracranial atherosclerotic stenosis, Remote ischemic conditioning, Stroke Read More

Inclusion Criteria:

• 1. Age ranging from 45 to 80 years of age, both genders;

  2. Patients diagnosed with an ischemic stroke or TIA before admission and the following requirements should be satisfied as well:

  1. The occurrence of an ischemic stroke within 30 days and with a baseline modified Rankin Scale (mRS) score≤4.
  2. The occurrence of an TIA within 15 days and with a baseline Oxfordshire Community Stroke Project on the basis of age, blood pressure (BP), clinical features, and duration of TIA symptoms (ABCD2) score≥4.

  3. Patients with symptomatic intracranial atherosclerotic stenosis (sIAS) that is attributed to at least 50% stenosis of the diameter of a major intracranial artery (carotid artery, or middle cerebral artery (M1)) verified by magnetic resonance angiography (MRA) or computed tomographic angiography (CTA).

  4. Informed consent obtained patients or health care proxy, as appropriate, able to cooperate and participate follow-up visits.

Exclusion Criteria:

• 1. Received intravenous or intraarterial thrombolytic therapy such as recombinant tissue plasminogen activator (rtPA) within 24 hours prior to inclusion.

  2. Progressive deterioration of neurological manifestations within 24 hours prior to inclusion.

  3. Intracranial arterial stenosis due to any of the following non-atherosclerotic etiologies, for instance, moyamoya disease, artery dissection, any known vasculitic disease, any intracranial infection, radiation induced vasculopathy, cerebrospinal fluid (CSF) pleocytosis associated intraarterial stenosis, genetic or developmental abnormalities such as fibromuscular dysplasia, neurofibromatosis, sickle cell disease, and mitochondrial encephalopathy, intracranial granulomatous arteritis, postpartum angiopathy, suspected vasospasm or embolism, iatrogenic trauma.

  4. Intracranial abnormalities such as tumor, abscess, vascular malformation, cerebral venous sinus stenosis or thrombosis.

  5. Any hemorrhagic transformation or large area of cerebral infarction (more than 1/3 of middle cerebral artery perfusion territory).

  6. Any type of intracranial hemorrhage within 90 days prior to inclusion.

  7. Potential cardiac source of embolism such as rheumatic mitral and or aortic stenosis, prosthetic heart valves, atrial flutter, atrial fibrillation, left atrial myxoma, sick sinus syndrome, patent foramen ovale, left ventricular mural thrombus or valvular vegetation, congestive heart failure, and bacterial endocarditis.

  8. Previous stent, angioplasty, or other mechanical device in the target lesion, or plan to receive any of the above procedures within 12 months after inclusion.

  9. Refractory hypertension (systolic blood pressure (SBP) >180 mmHg; diastolic blood pressure (DBP) >110 mmHg) that cannot be controlled by medical intervention.

  10. Above 50% stenosis of extracranial artery (carotid artery or vertebral artery).

  11. Above 50% stenosis of subclavian artery or subclavian steal syndrome.

  12. Retinal hemorrhage or visceral bleeding within 30 days prior to inclusion.

  13. Myocardial infarction within previous 30 days prior to inclusion.

  14. Previous history of major surgery within 30 days prior to inclusion, or arranged for any of the procedure within 12 months after inclusion.

  15. Severe hemostatic or coagulation disorders (Haemoglobin <10 g/dL, blood platelet count < 100 × 109/L).

  16. Hepatic or renal dysfunctions (aspartate transaminase (AST) and/or alanine transaminase (ALT) >3×upper limit of normal range, creatinine clearance <0.6 ml/s and/or serum creatinine >265 μmol/l (>3.0 mg/dl)).

  17. Current or having a history of chronic physical diseases or mental disorders.

  18. Life expectancy < 3 years due to concomitant life-threatening illness.

  19. Contraindications for remote ischemic conditioning: significant peripheral arterial disease, soft tissue or vascular injury, wounds, and fracture affecting the upper limbs.

  20. Pregnant or lactating women.

  21. Patients unlikely to be compliant with intervention or return for follow-up visits.

  22. No consent obtained from the patient or available legally authorized representatives.

  23. Patients recruited into another clinical investigation with medication or device, which is likely to impact the outcome of this study.