Safety and Efficacy of Remote Ischemic Conditioning for Cerebral Ischemia in Patients With Takayasu Arteritis: a Prospective Cohort Study

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
China
Department of Rheumatology and Allergy, Xuanwu Hospital, Capital Medical University, Beijing, China
RECRUITING
Beijing
Contact Information
Primary
Yi Zhao, MD
zy85070@xwhosp.org
+8613811038669
Backup
Fang kong, MD
kongfang90@163.com
+8613051116280
Time Frame
Start Date: 2024-01-01
Estimated Completion Date: 2025-07-31
Participants
Target number of participants: 44
Treatments
Experimental: RIC group
The RIC protocol includes five cycles of 5-min inflation to 200mmHg and 5-min deflation.
Sham_comparator: sham RIC group
The sham RIC protocol includes five cycles of 5-min inflation to 60mmHg and 5-min deflation.
Related Therapeutic Areas
Sponsors
Leads: Xuanwu Hospital, Beijing

This content was sourced from clinicaltrials.gov