Clinical trial NCT02876874: Relationship Between the Activity of Rheumatoid Arthritis and Lymph Node Morphology and Lymphatics Drainage
Official title: the Relationship Between the Activity of Rheumatoid Arthritis（RA） and Popliteal/Epitrochlear Lymph Node Morphology and the Drainage of Hand/Foot Superficial Lymphatic Vessels
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Rheumatoid Arthritis
Lymph Node Mass
Lymphatic Vessel; Dilatation
Keywords: Rheumatoid Arthritis
lymph nodes morphology
drainage of lymphatic vessels
Lead sponsor: Shanghai University of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2016-08-24
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study conducted in Shanghai, China. The participants will be recruited by advertisement in in Longhua hospital, communities and universities in Shanghai.

Brief summary: 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

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Patients fulfilling the classification criteria of American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) 2009 (scores more than 6 points)
2. Health participants normal in the test of blood/urine/stool routine, liver and kidney functions, electrocardiogram and without obvious medical history
3. Age 18 to 65 years
4. Fulling understood the whole trial and written informed consent.

Exclusion Criteria:

Participants will be excluded when they combined with:

1. other types of autoimmune diseases such as ankylosing spondylitis, systemic lupus erythematosus, scleroderma, etc.,
2. lymphatic system disorders, such as lymphoma, lymphangitis and lymphatic edema due to lymphatic flow disorders,
3. disorders that effect the circulation of lymph or blood vessels such as hemangiomas,
4. tumors or cancer,
5. operation history within a year, such as joint orthopedics, tumor resection, etc.,
6. allergies or allergic to iodine, or radioactive iodine treatment within the last year,
7. with metal objects inside, such as pacemakers or nails,
8. the skin for the ultrasound inspection not intact such as eczema,ulceration, etc.,
9. lactation or pregnancy women or preparation to be pregnant within the next half year,
10. without whole limbs to inspect,
11. mania, depression or other mental disorder
12. medical disorders such as diabetes, hypertension or hyperlipidemia, etc.,
13. a history of infectious diseases such as tuberculosis, hepatitis B or HIV, etc.,
14. a history of drug abuse such as opioid analgesics, sedative-hypnotics or alcohol abuse, etc.,
15. 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);
16. poor compliance.

Primary outcomes:
measure: T-initial
timeFrame: after the injection of ICG from the first day to the fourth day after
Secondary outcomes:
measure: S-max
timeFrame: after the injection of ICG, 1day after, 2 days after, 3 days after and 4days after
measure: T-max
timeFrame: after the injection of ICG, 1day after, 2 days after, 3 days after and 4days after
measure: %Clearance
timeFrame: after the injection of ICG, 1day after, 2 days after, 3 days after and 4days after
measure: Pulse
timeFrame: after the injection of ICG, 1day after, 2 days after, 3 days after and 4days after
measure: lymphatic node size
timeFrame: the second day after enrollment
measure: lymphatic node shape
timeFrame: the second day after enrollment
measure: lymphatic node transverse/longitudinal diameter ratio
timeFrame: the second day after enrollment
measure: lymphatic node types of edges
timeFrame: the second day after enrollment
measure: lymphatic node thickness of cortex/medulla
timeFrame: the second day after enrollment
measure: lymphatic node homogeneity
timeFrame: the second day after enrollment
measure: lymphatic node hilum
timeFrame: the second day after enrollment
measure: lymphatic node blood flow signal
timeFrame: the second day after enrollment
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Longhua Hospital, Shanghai University of TCM
state: Shanghai
city: Shanghai
country: China
facility: Longhua Hospital, Shanghai University of TCM
Study officials:
affiliation: Longhua Hospital
name: Yong-jun Wang, Dr.
role: PRINCIPAL_INVESTIGATOR
References: