NCT06178419 Remote Ischemic Conditioning for Cerebral Ischemia in Patients With Takayasu Arteritis (TARIC-1)
| NCT ID | NCT06178419 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Xuanwu Hospital, Beijing |
| Condition | Cerebral Ischemia |
| Study Type | INTERVENTIONAL |
| Enrollment | 44 participants |
| Start Date | 2024-01-01 |
| Primary Completion | 2025-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 44 participants in total. It began in 2024-01-01 with a primary completion date of 2025-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 indicators, imaging indicators, treatment data, adverse events, etc.The Primary outcome is the mean cerebral blood flow improvement rate ( mCBF-IR ) of TAK patients after 24 weeks-treatment. Secondary endpoints include the incidence of major adverse cerebrovascular events ( MACE ) , the change value of arterial transit time ( ATT ) in pCASL hypoperfusion area compared with baseline, occurrence of RIC-related adverse reactions, the changes of hematological indexes and disease activity score, etc. This study will provide insights into the preliminary proof of principle, safety, and efficacy of RIC in cerebral ischemia in patients with Takayasu arteritis ( TAK ), and this data will provide parameters for future larger scale clinical trials if efficacious.
Eligibility Criteria
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, severe myocardial ischemia, pulmonary hypertension, acute cerebral infarction, arterial dissection or aneurysm rupture, etc * There are serious complications, such as poorly controlled diabetes, renal insufficiency, cardiopulmonary insufficiency, mental illness or malignant tumor * There were moderate to severe stenosis of brachial artery in both upper limbs
Contact & Investigator
Yi Zhao, MD
PRINCIPAL INVESTIGATOR
Xuanwu Hospital, Capital Medical University, China, 10053
Frequently Asked Questions
Who can join the NCT06178419 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Cerebral Ischemia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06178419 currently recruiting?
Yes, NCT06178419 is actively recruiting participants. Contact the research team at zy85070@xwhosp.org for enrollment information.
Where is the NCT06178419 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT06178419 clinical trial?
NCT06178419 is sponsored by Xuanwu Hospital, Beijing. The principal investigator is Yi Zhao, MD at Xuanwu Hospital, Capital Medical University, China, 10053. The trial plans to enroll 44 participants.