Remote Ischemic Conditioning for Cerebral Ischemia in Patients With Takayasu Arteritis (TA
The aim of this study is to evaluate the safety and efficacy of remote ischemic conditioning ( RIC ) in the protection of cerebral ischemia in patients with Takayasu arteritis ( TAK ). The study was designed as a prospective, double-blind, exploratory randomized controlled study. The entire study included a screening p
| Condition(s) | Cerebral Ischemia, Takayasu Arteritis |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | The aim of this study is to evaluate the safety and efficacy of remote ischemic conditioning ( RIC ) in the protection of cerebral ischemia in patients with Takayasu arteritis ( TAK ). The study was designed as a prospective, double-blind, exploratory randomized controlled study. The entire study included a screening period and a treatment observation period ( a total of 24 weeks ). All patients with cerebral ischemia of TAK will be randomly divided into RIC group and sham RIC group at 1:1 ratio. On the basis of receiving the conventional drug therapy, the patients will be treated with RIC or sham RIC treatment twice daily for six month. The clinical data of patients at baseline and each follow-up will be collected, including basic information, disease activity assessment, laboratory indic |
| Who can participate | Inclusion Criteria: * All patients fulfilled the 1990 American College of Rheumatology Classification Criteria for TAK * Inactive state * Male and female, aged 18-65 years old * The presence of supra-aortic vascular involvement ( including but not limited to the left and right sides of the common carotid artery, subclavian artery, vertebral artery involvement ) * Decreased cerebral blood perfusion in the whole brain ( compared with healthy people ) or local ( left and right brain contrast ) suggested by pseudo-Continuous arterial spin labeling ( pCASL ) -MRI * Voluntary participation in this study, signed informed consent Exclusion Criteria: * Complications that endanger the function of important organs, such as uncontrollable heart failure, severe heart valve disease, severe hypertension, |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Lead sponsor | Xuanwu Hospital, Beijing |
| Locations | Beijing, Beijing Municipality, China |
| Start date | 2024-01-01 |
| NCT ID | NCT06178419 |
| Official listing | https://clinicaltrials.gov/study/NCT06178419 |