Effect of Remote Ischemic Preconditioning on Early Neurological Deterioration in Acute Perforating Artery Infarction
Effect of Remote Ischemic Preconditioning on Early Neurological Deterioration in Acute Perforating Artery Infarction (RIC-END): A Randomised Multicentre Trial
Jinling Hospital, China
910 participants
Dec 11, 2025
INTERVENTIONAL
Conditions
Summary
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).
Eligibility
Inclusion Criteria6
- Age 18 years or older;
- Diagnosed with acute ischemic stroke;
- Clinical symptoms consistent with perforating artery infarction (NIHSS score ≤5, with consciousness item 1a ≤1);
- Time from onset to randomization within 48 hours;
- 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 Criteria13
- Received intravenous thrombolysis or endovascular treatment prior to randomization;
- Secondary stroke caused by brain tumor, traumatic brain injury, hematologic disorders, or other conditions;
- History of intracranial hemorrhage;
- Presence of RIC contraindications, such as severe upper limb soft tissue injury, fracture, subclavian artery stenosis, or peripheral vascular disease;
- Uncontrolled severe hypertension (systolic blood pressure \[BP\] ≥180 mmHg or diastolic BP ≥110 mmHg);
- 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);
- Patients with thrombocytopenic purpura, coagulation disorders, or active visceral bleeding;
- Patients in the acute phase of fundus hemorrhage;
- History of severe aphasia or psychiatric disorders affecting clinical assessment;
- Life expectancy \<90 days;
- Pregnancy;
- Inability to comply with follow-up;
- Participation in other clinical trials.
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Interventions
The standard RIC procedure involves placing a blood pressure cuff on both upper limbs, rapidly inflating the cuff to occlude arterial blood flow and induce transient limb ischemia, followed by deflating the cuff to restore blood perfusion. RIC is administered twice daily on both upper limbs, with each session consisting of 5 cycles, for 5-7 consecutive days. The inflation pressure for RIC treatment is set at 200 mmHg.
The standard RIC procedure involves placing a blood pressure cuff on both upper limbs, rapidly inflating the cuff to occlude arterial blood flow and induce transient limb ischemia, followed by deflating the cuff to restore blood perfusion. RIC is administered twice daily on both upper limbs, with each session consisting of 5 cycles, for 5-7 consecutive days. The inflation pressure for RIC treatment is set at 60 mmHg.
Locations(1)
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NCT07237542