NCT06170944

Effect of Remote Ischemic Preconditioning on Collaterals of Atherosclerosis Stroke

Effect of Remote Ischemic Preconditioning on Collaterals of Atherosclerosis Stroke (RICAS): a Prospective, Randomized, Blind Endpoint, Multicenter Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: General Hospital of Shenyang Military Region · Academic / Other
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to explore the influence of chronic RIC on collateral status evaluated by DSA in ischemic stroke patients with LAA etiology.

Detailed description

Stroke is the second leading cause of death and the third leading cause of death and disability combined in the world. The remote ischemic preconditioning (RIC) procedure is low-cost with excellent properties of safety, tolerability and feasibility in both AIS and cardiovascular diseases. In this study, we aim to explore the influence of chronic RIC on collateral status evaluated by DSA in ischemic stroke patients with LAA etiology. The RICAS study is a prospective, randomized, blind endpoint, multicenter study. Eligible patients with ischemic stroke of anterior circulation with large artery atherosclerosis etiology, poor collateral compensation, and more than 1 month of the symptom onset, are randomly assigned into the experimental group and control group with a ratio of 1:1. The patients in experiment group will receive treatment with RIC for 1 year as an adjunct to guideline-based treatment, while patients in control group only receive guideline-based treatment. The primary outcome is proportion of collateral status improvement, which is defined as an increase of ASITN/SIR score of 1 or more assessed on DSA at 12 months after randomization. The safety outcomes include RIC-related adverse events. A maximum of 300 patients (150 participants per group) are required to test the superiority hypothesis with 80% power (using a two-sided α = 0.05) to detect the 15% difference. The primary endpoint will further be stratified by age, gender, inclusion event (acute ischemic stroke ore transient ischemic stroke), tandem lesion, history of hypertension, hypercholesterolemia, diabetes mellitus, ischemic stroke, transient ischemic attack, and myocardial infarction. This study will provide the direct evidence for improvement of collateral status by chronic RIC treatment.

Conditions

• Stroke, Ischemic

Interventions

Type	Name	Description
DEVICE	Remote ischemic preconditioning	The patients in experiment group will receive treatment with RIC (5 cycles of cuff inflation for 5 minutes and deflation for 5 minutes to the bilateral upper limbs to 200 mmHg) for 1 year as an adjunct to guideline-based treatment.

Timeline

• Start date: 2024-06-01
• Primary completion: 2025-11-30
• Completion: 2026-01-30
• First posted: 2023-12-14
• Last updated: 2025-08-21

Locations

1 site across 1 country: China