Evaluating Remote Ischemic Conditioning to Protect Brain Blood Flow in Adults with Takayasu Arteritis and Cerebral Ischemia

What this Trial Is About

Researchers are evaluating the safety and effectiveness of remote ischemic conditioning RIC as a treatment for cerebral ischemia in patients with Takayasu arteritis TAK. This is a prospective, double-blind, randomized controlled study designed to provide early evidence of RICs potential benefits and safety in protecting the brain from ischemic injury in TAK patients. Participants will be randomly assigned to receive either the RIC treatment or a sham RIC procedure. Both interventions are performed using automated pneumatic cuffs on one arm, with the RIC group undergoing five cycles of 5-minute inflation to 200 mmHg followed by 5-minute deflation, and the sham group receiving lower pressure inflations to 60 mmHg in the same cycle pattern. Treatments are given twice daily for six months, alongside conventional drug therapy. The study includes a screening phase and a 24-week treatment and observation period. Throughout the study, researchers will collect detailed clinical data at baseline and at 1, 2, 3, and 6 months. This includes symptom assessments, laboratory tests, imaging with pseudo-continuous arterial spin labeling MRI, vascular injury scores, and disease activity measures. The primary outcome is the improvement rate of cerebral blood flow after 24 weeks. Secondary outcomes include rates of major adverse cerebrovascular events, changes in arterial transit time, RIC-related side effects, blood pressure, inflammatory markers, and various blood factors related to vascular health. Safety and disease activity will also be monitored during follow-up visits.

Remote Ischemic Conditioning for Cerebral Ischemia in Patients With Takayasu Arteritis (TARIC-1)