Remote ischemic conditioning for acute moderate ischemic stroke (RICAMIS): Rationale and design.

ABSTRACT

RATIONALE A large number of basic and clinical studies have proved that remote ischemic conditioning has neuroprotective effect. For example, remote ischemic conditioning showed a neuroprotective role in cerebral ischemia-reperfusion injury model. Recent clinical studies suggested that remote ischemic conditioning may improve neurological function and reduce the risk of recurrence in ischemic stroke patients. However, there is a lack of convincing evidence for the neuroprotective effect of remote ischemic conditioning on ischemic stroke, which deserves further study. AIM: To explore the efficacy and safety of remote ischemic conditioning for acute moderate ischemic stroke. SAMPLE SIZE ESTIMATES A maximum of 1800 subjects are required to test the superiority hypothesis with 80% power according to a one-sided 0.025 level of significance, stratified by gender, age, time from onset to treatment, National Institutes of Health Stroke Scale (6-10 vs. 11-16), degree of responsible vessel stenosis, location of stenosis, and stroke etiology. METHODS AND DESIGN: Remote Ischemic Conditioning for Acute Moderate Ischemic Stroke is a prospective, random, open label, blinded endpoint and multi-center study. The subjects are divided into experimental group and control group randomly. The experimental group was treated with remote ischemic conditioning twice daily with 200 mmHg pressure for 10-14 days besides guideline-based therapy. The control group was treated according to the guidelines. STUDY OUTCOME: The primary efficacy endpoint is favorable functional outcome, defined as modified Rankin Scale 0-1 at 90 days post-randomization.