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

NCT ID: NCT02876874

Last Updated: 2016-08-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

21 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-12-31

Study Completion Date

2018-12-31

Brief Summary

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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

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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.

Conditions

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Rheumatoid Arthritis Lymph Node Mass Lymphatic Vessel; Dilatation

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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the patients group

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

indocyanine green(ICG)

Intervention Type DRUG

ICG will be injected into the dorsal of hand/foot

the health group

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

indocyanine green(ICG)

Intervention Type DRUG

ICG will be injected into the dorsal of hand/foot

Interventions

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indocyanine green(ICG)

ICG will be injected into the dorsal of hand/foot

Intervention Type DRUG

Other Intervention Names

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IC-GREENĀ®(indocyanine green for injection,USP),AKORN,Inc

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Shanghai University of Traditional Chinese Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yong-jun Wang, Dr.

Role: PRINCIPAL_INVESTIGATOR

Longhua Hospital

Locations

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Longhua Hospital, Shanghai University of TCM

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Longhua Hospital, Shanghai University of TCM

Shanghai, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Qianqian Liang, Dr.

Role: CONTACT

86-021-64875390

Qiong Wang

Role: CONTACT

86-13671779096

Facility Contacts

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Qianqian Liang, Doctor

Role: primary

86-021-64875390

Qiong Wang

Role: backup

86-13671779096

Qianqian Liang, Doctor

Role: primary

86-021-64875390

Qiong Wang

Role: backup

86-13671779096

Other Identifiers

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RA and lymphatic vessels

Identifier Type: -

Identifier Source: org_study_id

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