Ignite Creation Date:
2024-05-06 @ 7:53 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06178419
Status:
RECRUITING
Last Update Posted:
2023-12-21
First Post:
2023-11-21
Brief Title:
Remote Ischemic Conditioning for Cerebral Ischemia in Patients With Takayasu Arteritis TARIC-1
Sponsor:
Xuanwu Hospital Beijing
Organization:
Xuanwu Hospital Beijing
Study Overview
Official Title:
Safety and Efficacy of Remote Ischemic Conditioning for Cerebral Ischemia in Patients With Takayasu Arteritis a Prospective Cohort Study
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TARIC-1
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 11 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 etcThe 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
Detailed Description:
Clinical symptoms routine follow-up laboratory tests other serological indicators VEGF NGF ET-1 ACE PAF PDGF etc vascular involvement cranial MRI vascular injury score disease activity and treatment will be collected at baseline After RIC or sham RIC intervention clinical symptoms laboratory tests disease activity treatment and RIC-related adverse reactions will be collected at 1m 2m3m and 6m the data of vascular involvement cranial MRI vascular injury score and disease activity will also be collected at 6 months follow-up
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None