Relationship Between the Activity of Rheumatoid Arthritis and Lymph Node Morphology and Lymphatics Drainage

Shanghai University of Traditional Chinese Medicine

Status: Unknown

Conditions: Lymph Node Mass; Lymphatic Vessel; Dilatation; Rheumatoid Arthritis

Treatments: Drug: indocyanine green(ICG)

Study type: Observational

Funder types: Other

Identifiers

NCT02876874

RA and lymphatic vessels

Details and patient eligibility

About

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

Full 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.

Enrollment: 21 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

21 participants in 2 patient groups

the patients group

Description:

0.1ml, 5mg/ml indocyanine green(ICG) will be injected subcutaneously to aid visualization in NIR

Treatment:

Drug: indocyanine green(ICG)

the health group

Description:

0.1ml, 5mg/ml indocyanine green(ICG) will be injected subcutaneously to aid visualization in NIR

Treatment:

Drug: indocyanine green(ICG)