NCT07237542

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 910 (estimated)
• Sponsor: Jinling Hospital, China · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed description

Penetrating artery infarction (PAI) is a single small deep infarct within the territory of a perforating artery, accounting for 15.3%-25% of all ischemic strokes. Early neurological deterioration (END) is a critical factor contributing to poor prognosis in PAI. END is generally defined as an increase of ≥2 points on the National Institutes of Health Stroke Scale (NIHSS) within 7 days after stroke onset. Remote ischemic preconditioning (RIC) involves repeated, low-intensity ischemic training of both upper limbs to enhance the resistance of organs to severe ischemic injury. RIC confers protective effects on ischemic brain tissue and may serve as a new therapeutic approach for intracranial atherosclerosis and acute cerebral infarction. However, large-scale randomized controlled trials evaluating the clinical efficacy of RIC in acute PAI are lacking. Therefore, this study aims to conduct a multicenter, prospective, randomized clinical trial to scientifically assess the clinical efficacy of RIC in patients with acute PAI, providing evidence-based support for its application in this population. In this trial, patients with acute PAI (within 48 hours from onset to randomization) will be included. In the screening stage, participants who meet the trial's inclusion criteria-after completing screening/baseline assessment and signing the informed consent-will be randomly assigned in a 1:1 ratio to one of the following two treatment groups: the experimental group will receive RIC (200 mmHg), and the control group will receive sham RIC (60 mmHg). The primary end point is the incidence of END within 5 days after randomization.

Conditions

• Ischemic Stroke
• Remote Ischaemic Preconditioning

Interventions

Type	Name	Description
DEVICE	remote ischemic preconditioning	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.
DEVICE	sham remote ischemic preconditioning	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.

Timeline

• Start date: 2025-12-11
• Primary completion: 2027-11-20
• Completion: 2027-11-20
• First posted: 2025-11-20
• Last updated: 2026-02-03

Locations

1 site across 1 country: China