Remote ischemic conditioning for cerebral ischemia in patients with Takayasu arteritis (TARIC-1): Study protocol.
Shuangfeng Huang, Fang Kong, Wenbo Zhao...
https://pubmed.ncbi.nlm.nih.gov/42111310Actively Recruiting
Phase Not Applicable
Age: 18Years - 65Years
All Genders
ID06178419
Safety and Efficacy of Remote Ischemic Conditioning for Cerebral Ischemia in Patients With Takayasu Arteritis: a Prospective Cohort Study
Led by Xuanwu Hospital, Beijing · Updated on 2024-09-19
44
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
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 RIC's 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.
CONDITIONS
Brief Title
Remote Ischemic Conditioning for Cerebral Ischemia in Patients With Takayasu Arteritis (TARIC-1)
Who Can Participate
Age: 18Years - 65Years
All Genders
Eligibility Criteria
You may qualify if you...
- Patients must meet the 1990 American College of Rheumatology Classification Criteria for Takayasu arteritis (TAK)
- Disease must be in an inactive state
- Male and female patients aged 18 to 65 years old
- Presence of supra-aortic vascular involvement, including common carotid artery, subclavian artery, or vertebral artery involvement
- Decreased cerebral blood perfusion in whole brain or local areas shown by pCASL MRI
- Voluntary participation with signed informed consent
You will not qualify if you...
- Having serious complications that threaten important organ function, such as uncontrollable heart failure, severe heart valve disease, severe hypertension, severe myocardial ischemia, pulmonary hypertension, acute cerebral infarction, arterial dissection, or aneurysm rupture
- Serious complications like poorly controlled diabetes, renal insufficiency, cardiopulmonary insufficiency, mental illness, or malignant tumor
- Moderate to severe stenosis of brachial artery in both upper limbs
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Implementation
Duration - Single session at baseline
Participants receive Remote Ischemic Conditioning (RIC) or sham-RIC using automated pneumatic cuffs on one arm, involving cycles of inflation and deflation.
1 baseline visit (in-person)
Monitoring
Duration - 6 months
After the intervention, participants are monitored for clinical symptoms, laboratory tests, disease activity, treatment, and RIC-related adverse reactions.
Visits at 1 month, 2 months, 3 months, and 6 months (in-person)
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
Loading map...
Research Team
Y
Yi Zhao, MD
F
Fang kong, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here