Using remote ischemic conditioning to protect against cerebral ischemia in Takayasu arteritis patients
Safety and Efficacy of Remote Ischemic Conditioning for Cerebral Ischemia in Patients With Takayasu Arteritis: a Prospective Cohort Study
This study is testing if a new treatment called remote ischemic conditioning can help protect the brains of people with Takayasu arteritis from damage caused by reduced blood flow.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 44 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Xuanwu Hospital, Beijing Academic / other |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT06178419 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and efficacy of remote ischemic conditioning (RIC) in protecting against cerebral ischemia in patients diagnosed with Takayasu arteritis. It is designed as a prospective, double-blind, exploratory randomized controlled trial, where participants will be randomly assigned to either the RIC group or a sham RIC group. The intervention will occur twice daily for six months, alongside conventional drug therapy. Clinical data will be collected at baseline and during follow-ups to assess improvements in cerebral blood flow and other health indicators over a 24-week period.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-65 with Takayasu arteritis who exhibit cerebral ischemia and meet specific inclusion criteria.
Not a fit: Patients with severe complications affecting vital organ function or uncontrolled comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve cerebral blood flow and overall outcomes for patients with Takayasu arteritis.
How similar studies have performed: While the use of remote ischemic conditioning is a novel approach in this context, similar studies have shown promise in other conditions, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Beijing, Beijing Municipality
- Department of Rheumatology and Allergy, Xuanwu Hospital, Capital Medical University, Beijing, China — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Principal investigator: Yi Zhao, MD — Xuanwu Hospital, Capital Medical University, China, 10053
- Study coordinator: Yi Zhao, MD
- Email: zy85070@xwhosp.org
- Phone: +8613811038669
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.