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

NCT02876874 | Unknown DMC

• 1 other identifier: RA and lymphatic vessels
• Study Type: observational
• Target: 21
• Locations: 1 country
• Sites: 2

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

Conditions

Rheumatoid Arthritis; Lymph Node Mass; Lymphatic Vessel; Dilatation

Keywords

Rheumatoid Arthritis; lymph nodes morphology; drainage of lymphatic vessels

Outcome Measures

Primary Outcomes (1)

• T-initial

  the time that it takes for the ICG to be detected in vessels

  after the injection of ICG from the first day to the fourth day after

Secondary Outcomes (12)

• S-max

  after the injection of ICG, 1day after, 2 days after, 3 days after and 4days after

• T-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

Study Arms (2)

the patients group

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

Drug: indocyanine green(ICG)

the health group

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

Drug: indocyanine green(ICG)

Interventions

indocyanine green(ICG) DRUG

ICG will be injected into the dorsal of hand/foot

Also known as: IC-GREEN®(indocyanine green for injection,USP),AKORN,Inc

the health group; the patients group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.,

Sponsors & Collaborators

• Shanghai University of Traditional Chinese Medicine: lead

Study Sites (2)

Longhua Hospital, Shanghai University of TCM

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Longhua Hospital, Shanghai University of TCM

Shanghai, 200032, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Peripheral blood 10ml for the analysis of cytokines,such as IL-1/6, TNF-α,VEGF-3 recepter,VEGFRC/E, et al.

MeSH Terms

Conditions

Arthritis, Rheumatoid; Dilatation, Pathologic

Interventions

Indocyanine Green

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Yong-jun Wang, Dr.

  Longhua Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Qianqian Liang, Dr.

CONTACT

86-021-64875390; liangqianqiantcm@126.com

Qiong Wang

CONTACT

86-13671779096; 13671779096@163.com

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Target Duration: 7 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2015
• First Posted: August 24, 2016
• Study Start: December 1, 2014
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2018
• Last Updated: August 24, 2016

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)