Remote ischemic conditioning for cerebral ischemia in patients with Takayasu arteritis (TARIC-1): Study protocol

Abstract AIM: The purpose of this study is to investigate the safety and effectiveness of remote ischemic conditioning (RIC) as a therapeutic intervention for cerebral ischemia in patients with Takayasu arteritis (TA). METHODS: TARIC-1 is a randomized, double-blind, parallel-group pilot trial conducted at Xuanwu Hospital, Capital Medical University. Participants with TA and reduced cerebral blood perfusion are randomly allocated to either the RIC or sham-RIC groups. Both the groups receive conventional medical care, with the RIC group receiving twice-daily sessions of 200 mmHg inflation pressure and the sham-RIC group receiving 60 mmHg inflation pressure, for 24 consecutive weeks. OUTCOMES: The primary outcome is the change in mean cerebral blood flow across the entire brain and regions of interest following the 24-week RIC treatment. Secondary outcomes include clinical assessments using the Indian Takayasu Clinical Activity Score 2010, Vasculitis Damage Index, and Birmingham Vasculitis Activity Score at 24 weeks postintervention. Changes in arterial transit time and the incidence of major adverse cerebrovascular events are additional secondary outcomes. Safety outcomes include mortality and any adverse events, including skin changes and pain ratings, within the 24-week period. SAMPLE SIZE ESTIMATES: This pilot study plans to enroll 22 patients per group, totaling 44 participants. CONCLUSIONS: In individuals with TA, RIC may be a well-tolerated treatment that enhances cerebral perfusion and lowers the risk of ischemic cerebrovascular episodes. TRIAL REGISTRATION: http://www.clinicaltrials.gov (identifier: NCT06178419).