the Relationship Between the Activity of Rheumatoid Arthritis（RA） and Popliteal/Epitrochlear Lymph Node Morphology and the Drainage of Hand/Foot Superficial Lymphatic Vessels
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- T-initial
研究概览
简要总结
To observe the relationship between the activity of rheumatoid arthritis and popliteal/epitrochlear lymph node morphology and the drainage of hand/foot superficial lymphatic vessels
详细描述
Rheumatoid Arthritis patients and health participants will be recruited in our research. Then the classification of American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) 2009 will be used to identify rheumatoid arthritis patients. The measurement of disease activity are Disease Activity Score 28 (DAS28) combined with the synovitis, bone edema and bone erosion of hand and wrist detected by magnetic resonance (MR) and Doppler ultrasound (DUS).The morphology of lymph node in popliteal/epitrochlear are scanned by 3-dimensional MR and DUS. The drainage of hand/foot superficial lymphatic vessels are detected in sight of near infrared ray (NIR) with the applying of Indocyanine Green (ICG) subcutaneously. We'll conduct correlation analysis to reveal the relationship between the activity of Rheumatoid Arthritis and lymph nodes morphology and lymphatic vessels drainage.
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
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
- 是
入选标准
- •Patients fulfilling the classification criteria of American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) 2009 (scores more than 6 points)
- •Health participants normal in the test of blood/urine/stool routine, liver and kidney functions, electrocardiogram and without obvious medical history
- •Age 18 to 65 years
- •Fulling understood the whole trial and written informed consent.
排除标准
- •Participants will be excluded when they combined with:
- •other types of autoimmune diseases such as ankylosing spondylitis, systemic lupus erythematosus, scleroderma, etc.,
- •lymphatic system disorders, such as lymphoma, lymphangitis and lymphatic edema due to lymphatic flow disorders,
- •disorders that effect the circulation of lymph or blood vessels such as hemangiomas,
- •tumors or cancer,
- •operation history within a year, such as joint orthopedics, tumor resection, etc.,
- •allergies or allergic to iodine, or radioactive iodine treatment within the last year,
- •with metal objects inside, such as pacemakers or nails,
- •the skin for the ultrasound inspection not intact such as eczema,ulceration, etc.,
- •lactation or pregnancy women or preparation to be pregnant within the next half year,
- •without whole limbs to inspect,
- •mania, depression or other mental disorder
- •medical disorders such as diabetes, hypertension or hyperlipidemia, etc.,
- •a history of infectious diseases such as tuberculosis, hepatitis B or HIV, etc.,
- •a history of drug abuse such as opioid analgesics, sedative-hypnotics or alcohol abuse, etc.,
- •severe liver or kidney dysfunction (Alanine Aminotransferase(ALT) or Aspartate Aminotransferase(AST) two times higher than the upper limit of normal, serum creatinine levels more than two times the upper limit of normal);
- •poor compliance.
研究组 & 干预措施
the patients group
0.1ml, 5mg/ml indocyanine green(ICG) will be injected subcutaneously to aid visualization in NIR
干预措施: indocyanine green(ICG) (Drug)
the health group
0.1ml, 5mg/ml indocyanine green(ICG) will be injected subcutaneously to aid visualization in NIR
干预措施: indocyanine green(ICG) (Drug)
结局指标
主要结局
T-initial
时间窗: after the injection of ICG from the first day to the fourth day after
the time that it takes for the ICG to be detected in vessels
次要结局
- lymphatic node transverse/longitudinal diameter ratio(the second day after enrollment)
- T-max(after the injection of ICG, 1day after, 2 days after, 3 days after and 4days after)
- S-max(after the injection of ICG, 1day after, 2 days after, 3 days after and 4days after)
- %Clearance(after the injection of ICG, 1day after, 2 days after, 3 days after and 4days after)
- Pulse(after the injection of ICG, 1day after, 2 days after, 3 days after and 4days after)
- lymphatic node size(the second day after enrollment)
- lymphatic node shape(the second day after enrollment)
- lymphatic node types of edges(the second day after enrollment)
- lymphatic node thickness of cortex/medulla(the second day after enrollment)
- lymphatic node homogeneity(the second day after enrollment)
- lymphatic node hilum(the second day after enrollment)
- lymphatic node blood flow signal(the second day after enrollment)