This study aims to conduct a prospective, randomized, double-blind, multicenter, parallel-controlled, group-sequential trialto scientifically evaluate the safety and efficacy of remote ischemic preconditioning (RIC) in preventing early neurological deterioration (END) in patients with acute perforating artery infarction (PAI).
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Eligibility Criteria
Inclusion Criteria:
1. Age 18 years or older;
2. Diagnosed with acute ischemic stroke;
3. Clinical symptoms consistent with perforating artery infarction (NIHSS score ≤5, with consciousness item 1a ≤1);
4. Time from onset to randomization within 48 hours;
5. Diffusion-weighted imaging (DWI) showing…
Inclusion Criteria:
1. Age 18 years or older;
2. Diagnosed with acute ischemic stroke;
3. Clinical symptoms consistent with perforating artery infarction (NIHSS score ≤5, with consciousness item 1a ≤1);
4. Time from onset to randomization within 48 hours;
5. Diffusion-weighted imaging (DWI) showing a single infarct in the perforating artery territory with a maximum diameter ≤30 mm, meeting at least one of the following:
(1) Diameter ≤15 mm and involving two or more axial slices; (2) Maximum diameter ≥15 mm; (3) Connected to the ventral surface of the pons but not crossing the midline; 6) Stenosis of parent artery \<70%; 7) Signed informed consent obtained from the patient or their legally authorized representative.
Exclusion Criteria:
1. Received intravenous thrombolysis or endovascular treatment prior to randomization;
2. Secondary stroke caused by brain tumor, traumatic brain injury, hematologic disorders, or other conditions;
3. History of intracranial hemorrhage;
4. Presence of RIC contraindications, such as severe upper limb soft tissue injury, fracture, subclavian artery stenosis, or peripheral vascular disease;
5. Uncontrolled severe hypertension (systolic blood pressure \[BP\] ≥180 mmHg or diastolic BP ≥110 mmHg);
6. Severe hepatic or renal dysfunction (Alanine Aminotransferase or Aspartate Aminotransferase \> 3 × upper limit of normal; creatine kinase \>3 × upper limit of normal; estimated Glomerular Filtration Rate \< 30 mL / min / 1.73 m²);
7. Patients with thrombocytopenic purpura, coagulation disorders, or active visceral bleeding;
8. Patients in the acute phase of fundus hemorrhage;
9. History of severe aphasia or psychiatric disorders affecting clinical assessment;
10. Life expectancy \<90 days;
11. Pregnancy;
12. Inability to comply with follow-up;
13. Participation in other clinical trials.
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