The Cohort Study of East Chinese Takayasu's Arteritis (ECTA-cohort Study)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- The change of manifestations of systemic symptom - fever
研究概览
简要总结
The Takayasu arteritis (TA) is a rare inflammatory large vessel arteritis which often occurs women in Aisa, one of which is China. The rare cases restricted the development of intervention strategy, especially in female patients who plan to be pregnant. So investigators try to recruit as many TA participants as possible to build a TA cohort so that investigators could manage patients much more professionally and standardized and explore the better interventional strategy for a better outcome as well, with full use of blood and vascular tissues.
详细描述
- Overview of Takayasu's arteritis.
Takayasu arteritis (TA) is a chronic inflammatory blood vessel that seriously endangers human health, which affects a large variety of blood vessels, characterized by vascular stenosis and occlusion. The clinical manifestations of TA are hypertension, renal failure caused by renal artery stenosis; pulseless, syncope and cerebral infarction caused by carotid vessels stenosis; pulmonary infarction induced by thoracic aorta involvement, etc. The TA usually accompanies high morbidity, high mortality, and poor prognosis. TA is a rare disease which is prone to occur in Asian women, especially in young women (20-40 years old) in the growth period. Currently, the etiology and pathogenesis of TA remain unclear, and the state of the disease is often repeatedly active and continuously progressive. Moreover, non-effective therapy exists for the moment. 2. The diagnosis and activity evaluation of TA
At present, TA is diagnosed according to the American Society of Rheumatology (ACR) classification criteria for Takayasu's arteritis: ① onset at age ≤40 years; ② claudication of an extremity; ③ decreased brachial artery pulse; ④ >10 mm Hg difference in systolic blood pressure between arms; ⑤ a bruit over the subclavian arteries or the aorta; ⑥ and arteriographic evidence of narrowing or occlusion of the entire aorta, its primary branches, or large arteries in the proximal upper or lower extremities. Participants who meet 3 or more criteria could be diagnosed with this disease posterior to excluding atherosclerosis, congenital muscle fiber dysplasia, etc.
The course of TA is often manifested as chronic, repetitive activity and continuous progression. The evaluation standard proposed by Kerr et al. to monitor TA activity is widely used clinically. Two more new emerging or aggravating clinical manifestations indicates disease Activity: ① systemic symptom, such as fever, bones, muscle symptoms; ② increased erythrocyte sedimentation rate (ESR); ③characteristics of vascular ischemia or inflammation: such as intermittent claudication, pulse weakening or pulseless, vascular bruit, vascular pain, asymmetry blood pressure, etc.; ④ abnormalities in angiography. Although acute phase response protein such as ESR and C-reactive protein (CRP) are non-specific indicators for inflammation, they are still important markers to evaluate the disease activity. Imaging follow-up, primarily based on magnetic resonance imaging (MRI) and color Doppler ultrasound, is critical in assessing TA disease activity. With the help of Pro. Jiang Lin and Dr. Lu Peng, investigators have established an imaging diagnostic team in recent years and proposed the systemic MRI scoring standard in the international firstly. The standard has been applied to quantitatively assess the vascular inflammation prior and posterior to the treatment in participants with TA. Recently, investigators co-operated with the Department of Nuclear Medicine and Radiology to employ the 18F-FDG-PET/CT to evaluate the systemic vascular inflammation and disease activity in participants. Moreover, investigators attempted to use contrast-enhanced ultrasound microbubble imaging to assess the carotid artery inflammation and stenosis. At present, these two technologies are still being explored. Therefore, it is necessary to combine the clinical manifestations, acute phase response proteins (ESR and CRP) and imaging to judge the TA disease activity comprehensively. 3. Treatment of arteritis
The treatment of TA is divided into two phases: remission induction period and maintenance period. The drugs are divided into three categories including glucocorticoids, cytotoxic drugs, and biological agents targeting inflammatory cytokines.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
scramble TA group
Compared to sham TA group in the cohort, scramble TA group refers to TA patients who are given novel drugs or new drugs which are safe to treat other autoimmune diseases but have not been used to treat TA yet, or some new interventions and so on.
干预措施: Tocilizumab (Biological)
scramble TA group
Compared to sham TA group in the cohort, scramble TA group refers to TA patients who are given novel drugs or new drugs which are safe to treat other autoimmune diseases but have not been used to treat TA yet, or some new interventions and so on.
干预措施: Leflunomide (Drug)
结局指标
主要结局
The change of manifestations of systemic symptom - fever
时间窗: Through study completion, an average of 2 months.
The change of manifestations of systemic symptoms could effectively reflect the disease status of patients. The systemic symptoms associated with Takayasu arteritis mainly consist of fever, fatigue and chest congestion. Fever is examined by thermometer with the axillary's temperature, and the T\>37.5 degree is considered to be fever. After investigators excluding the fever caused by infection through CT or laboratory examinations, the occurrence of fever usually indicates the disease activity.
The change of the emerging signs or symptoms of ischemia
时间窗: Through study completion, an average of 2 months.
Multiple emerging signs or symptoms could sensitively reflect the extent of ischemia of artery or organs. Self-reported emerging signs or symptoms of ischemia including vascular pain, dizziness, headache, amaurosis, vision loss, blurred vision, palpitations, chest pain, abdominal pain, claudication and other symptom through inquiry are recorded by investigators and classified as "WITH" and "WITHOUT". Participants with emerging signs or symptoms of ischemia usually face aggravating TA disease.
The change of the signs or symptoms of ischemia
时间窗: Through study completion, an average of 2 months.
The vascular bruits and pulse strength are evaluated and scored from 0 to 2 (0=without bruits and pulse; 1=bruits and decreased pulse; 2= normal) by a special well-trained investigator. If the score decreases, the ischemia is exacerbated and classified as "WITH".
The change of the blood pressure
时间窗: Through study completion, an average of 2 months.
The blood pressure change is measured with sphygmomanometer by the investigators. The measure is performed three times in each visit, and the mean systolic blood pressure (SBP) and mean diastolic blood pressure (DBP) are recorded. If the pressure fluctuates over 20mmHg, the stenosis of artery may exacerbate and the disease might be in the active phase.
The change of manifestations of systemic symptom - fatigue
时间窗: Through study completion, an average of 2 months.
The occurrence of fatigue indicates that the disease might be in the active phase. Self reported fatigue is obtained through inquiry, recorded by investigators and classified as "WITH" and "WITHOUT".
The change of manifestations of systemic symptoms - chest congestion
时间窗: Through study completion, an average of 2 months.
The occurrence of chest congestion indicates that the heart and pulmonary might be involved and the disease might be in the active phase. Self reported chest congestion is obtained through inquiry, recorded by investigators and classified as "WITH" and "WITHOUT".
The change of laboratory tests.
时间窗: Through study completion, an average of 2 months.
The laboratory inflammatory markers such as erythrocyte sedimentation rate (ESR) are concise and efficient methods to monitor the change of disease status, and are examined by clinical laboratory in Zhongshan Hospital of Fudan University. Investigators record and summarize the results and evaluate the change of ESR under different treatment options.
The change of IL-6 in plasma
时间窗: Through study completion, an average of 2 months.
IL-6 plays an important role in the progression of Takayasu arteritis. The level of plasma IL-6 is detected by clinical laboratory in Zhongshan Hospital of Fudan University. Investigators record and summarize the results and evaluate the change of IL-6 under different interventions, and analyze the relationship between IL-6 and disease status.
The change of vascular imaging.
时间窗: Through study completion, an average of 2 months.
MRA and contrast-enhanced carotid ultrasound imaging are important methods to evaluate TA vascular inflammation and structural change. In the initial interview and every 3 times of follow-up, the imaging examination are carried out and the images are stored at the hospital. Two radiologists perform the independent reading and evaluation. Vascular imaging is employed to monitor the improvement of the vascular wall inflammation and vascular structures (including vessel wall thickness and vascular stenosis) during treatment. For patients with stent or other metallic foreign things in the body, PET-CT and CT are also used to examine the shape and lumen of the vessels.
The change of quality of life(QOF): SF-36 questionnaire
时间窗: Through study completion, an average of 2 months.
The change of Quality of Life (QOF) with the SF-36 questionnaire Self reported the change of quality of life. Patients complete the SF-36 quality of life assessment questionnaire. Investigators provide the guidance and training on how to complete the questionnaire but must not interfere with the patients' own choice. Investigators evaluate the change of overall quality of life of patients and score the change from 0 to 2 (0= alleviated, 1=similar, 2= worsen).
次要结局
- The change of obstetric related examinations in childbearing women.(From the initiation of pregnancy, 1 year.)