RecruitingACTRN12617000170325

T-BIRD: Tissue Biomechanics and Inflammation in the Rheumatic Diseases

T-BIRD: Tissue Biomechanics and Inflammation in the Rheumatic Diseases The Relationship Between Articular, Cutaneous and Vascular Biomechanical Properties, The Risk of Developing and the Severity of the Arthritis and Cardiovascular Disease Occurring in Rheumatoid and Psoriatic Arthritis – A Preliminary Study


Sponsor

Dr Stephen Oakley

Enrollment

375 participants

Start Date

Feb 22, 2017

Study Type

Observational

Conditions

Summary

The currently accepted paradigm holds that systemic autoimmunity and inflammation have a directly causal relationship with rheumatoid arthritis (RA) and psoriatic arthritis (PsA) and with the associated cardiovascular (CV) disease. However, the evidence supporting this paradigm is inconclusive and possibly contradicted but clinical studies. The T-BIRD study inverts the existing paradigm to explore the hypothesis that while autoimmunity sets the stage for the development of arthritis, it is the connective tissue biomechanical properties (stiffness) that: 1. Determine the risk of developing RA and PsA 2. Influence the severity of the RA and PsA and; 3. Determine the severity of the CV disease seen in association with RA and PsA . If this hypothesis is confirmed then a considerable part of the inheritance of RA and PsA (much of which remains unaccounted for) might be explained. There would also be important clinical implications as it would change the way clinicians undertake risk assessment and therapeutic decisions in managing inflammatory arthritis and its associated cardiovascular disease. This preliminary study will begin exploring this hypothesis by evaluating the relationship between articular biomechanical characteristics in the joints, skin and arteries and exploring the relationships between tissue biomechanical properties upon rheumatoid and psoriatic arthritis and vascular and cutaneous disease.


Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 80 Yearss

Plain Language Summary

Simplified for easier understanding

This study is investigating whether the stiffness of tissues (like joints, skin, and blood vessels) plays a role in the development and severity of rheumatoid arthritis (RA) and psoriatic arthritis (PsA). Most research has focused on the immune system attacking the joints, but this study explores a new idea — that connective tissue properties might also drive disease development and heart disease risk. It recruits people with RA, psoriatic arthritis, psoriasis, as well as healthy volunteers and people with benign joint hypermobility. You may be eligible if: - You are aged 18 to 80 years old - You have ACPA-positive rheumatoid arthritis, OR you are a first-degree relative of someone with RA, OR you have a positive ACPA blood test without RA, OR you have psoriatic arthritis, OR you have skin psoriasis without arthritis - OR you are a healthy person unrelated to anyone with RA - OR you have benign joint hypermobility You may NOT be eligible if: - You have conditions affecting the skin such as lupus, scleroderma, or heavy alcohol use (for a sub-study involving a syringe test) - You have already had corticosteroid treatment (for the main study groups) Talk to your doctor about whether this trial might be right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Assessments of the elasticity / stiffness of the joints, skin and arteries. 1. Participants will answer a simple 5-point questionnaire asking questions about the mobility of their joints. 2. An asse

Assessments of the elasticity / stiffness of the joints, skin and arteries. 1. Participants will answer a simple 5-point questionnaire asking questions about the mobility of their joints. 2. An assessor will painlessly assess the range of motion of the joints of the finger joints, wrists, elbows, knees and spine. 3. The flexibility of the right 5th finger will be formally tested in a device that stretches the finger backwards using specific forces (torques). 4. The skin elasticity will be evaluated first by drawing two dots 10 mm apart on th dorm of the right hand and measuring how far they can be stretched apart by the examiner. 5. The skin elasticity of the solar aspect of the right forearm will be measured as the volume of skin/tissue that can be drawn into the barrel of a 50mL syringe (plunger removed) in response to specific negative pressures. 6. The thickness of the skin will be measured at both sites using a pair of Harpenden skin fold callipers. 7. Arterial stiffest will be firstly measured as carotid-femoral pulse wave velocity (the delay between the the carotid and femoral pulses measured using a pressure transducer applied to the carotid and an inflatable cuff around the thigh. Carotid-Femoral Pulse Wave Velocity will be repeated on a second occasion 1 day - 4 weeks of the first assessment. Then endothelial fiction, the ability to dilate, will be measured as the strength of the pulses in the finger tips after a 5 minute period of complete occlusion of blood flow to the left arm using an inflatable cuff. Assessment of the severity of arthritis (in the rheumatoid arthritis and psoriatic arthritis groups) 1. Severity of arthritis will be evaluated as the number of tender and swollen joints, blood tests for inflammation (ESR, CRP) (to determine how well arthritis is controlled) and 2. The strength of treatment required to achieve this control (what drugs the participant is receiving). These assessments will be conducted over two visits. The majority of the assessments can be completed on the first visit. Upon the second visit carotid-femora pulse wave velocity will be measured a second time and any assessments not already conducted on the first occasion will be completed on the second occasion.


Locations(1)

John Hunter Hospital - New Lambton

NSW, Australia

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ACTRN12617000170325


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