Actively Recruiting
Remote Ischemic Conditioning for Cerebral Ischemia in Patients With Takayasu Arteritis (TARIC-1)
Led by Xuanwu Hospital, Beijing · Updated on 2024-09-19
44
Participants Needed
1
Research Sites
82 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Remote Ischemic Conditioning for Cerebral Ischemia in Patients With Takayasu Arteritis (TARIC-1)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must meet the 1990 American College of Rheumatology criteria for Takayasu arteritis
- Must be in inactive disease state
- Male or female aged 18 to 65 years
- Must have supra-aortic vascular involvement
- Must have decreased cerebral blood flow shown by pCASL-MRI
- Must voluntarily agree to participate and sign informed consent
You will not qualify if you...
- Having serious organ-threatening complications such as uncontrollable heart failure, severe heart valve disease, severe hypertension, severe myocardial ischemia, pulmonary hypertension, acute cerebral infarction, arterial dissection, or aneurysm rupture
- Having serious conditions like poorly controlled diabetes, kidney failure, cardiopulmonary failure, mental illness, or cancer
- Having moderate to severe narrowing of the brachial arteries in both upper limbs
AI-Screening
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Trial Site Locations
Total: 1 location
1
Department of Rheumatology and Allergy, Xuanwu Hospital, Capital Medical University, Beijing, China
Beijing, Beijing Municipality, China, 100053
Actively Recruiting
Research Team
Y
Yi Zhao, MD
CONTACT
F
Fang kong, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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