Remote ischemic preconditioning to prevent early worsening after small deep (perforating artery) ischemic stroke

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, randomized, double-blind, multicenter, parallel-controlled, group-sequential trial comparing remote ischemic preconditioning (RIC) to a sham procedure in a 1:1 allocation. Adults with acute perforating artery infarction within 48 hours, low NIHSS scores, and a single small DWI-confirmed lesion are enrolled and treated with repeated brief limb ischemia or sham. The primary focus is on preventing early neurological deterioration (an increase of ≥2 points on the NIHSS within 7 days) with monitoring of safety and clinical outcomes. The trial aims to provide rigorous evidence on whether RIC reduces early worsening and improves short-term neurological status in this specific stroke subtype.

Why it matters

Who can join: the full rules

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.

Where it's running

• Jinling Hospital, Medical School of Nanjing University, Nanjing
  Nanjing, Jiangsu, China Recruiting

Study contacts

• Study coordinator: Wusheng Zhu, PhD
• Email: wusheng.zhu@nju.edu.cn
• Phone: +86 2584801861

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.