Safety and Efficacy of Remote Ischemic Conditioning for Cerebral Ischemia in Patients With Takayasu Arteritis: a Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Mean cerebral blood flow improvement rate
研究概览
简要总结
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.
详细描述
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, 2m,3m and 6m. the data of vascular involvement, cranial MRI, vascular injury score and disease activity will also be collected at 6 months follow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Mean cerebral blood flow improvement rate
时间窗: during baseline to 6 months after therapy
Mean cerebral blood flow improvement rate ( mCBF-IR ) of TAK patients will be obtained by pseudo-continuous arterial spin labeling ( pCASL ) -MRI.
次要结局
- The number of patients not tolerating RIC procedure,and refuse to continue the RIC procedure(during baseline to 6 months after therapy)
- The change value of erythrocyte sedimentation rate (ESR)(during baseline to 1, 2, 3, 6months after therapy)
- The change value of serum level of vascular endothelial growth factor (VEGF)(during baseline to 6months after therapy)
- The change value of arterial transit time ( ATT )(during baseline to 6 months after therapy)
- The number of patients with erythema,and/or skin lesions related to RIC(during baseline to 6 months after therapy)
- The change value of blood pressure (BP)(during baseline to 1, 2, 3, 6months after therapy)
- The change value of C reactive protein (CRP)(during baseline to 1, 2, 3, 6months after therapy)
- The change value of serum level of nerve growth factor (NGF)(during baseline to 6months after therapy)
- The change value of serum level of endothelin-1 (ET-1)(during baseline to 6months after therapy)
- The change value of serum level of platelet growth factor ( PDGF )(during baseline to 6months after therapy)
- The change value of Birmingham Vasculitis Activity Score (BVAS)(during baseline to 6months after therapy)
- The change value of the number of affected blood vessels(during baseline to 6months after therapy)
- Incidence of major adverse cerebrovascular events ( MACE )(during baseline to 6 months after therapy)
- The number of patients with palpation for tenderness related to RIC(during baseline to 6 months after therapy)
- The number of patients with any other adverse events related to RIC intervention(during baseline to 6months after therapy)
- Incidence of clinical symptoms(during baseline to 1, 2, 3, 6months after therapy)
- The change value of C reactive proteininterleukin 6 (IL-6)(during baseline to 1, 2, 3, 6months after therapy)
- The change value of serum level of angiotensin converting enzyme (ACE)(during baseline to 6months after therapy)
- The change value of serum level of platelet activating factor (PAF)(during baseline to 6months after therapy)
- The change value of the Indian Takayasu Clinical Activity Score (ITAS) 2010(during baseline to 6months after therapy)
- The change value of the Vasculitis Damage Index (VDI)(during baseline to 6months after therapy)
- Rate of the usage of glucocorticoids(during baseline to 6months after therapy)