Cardiovascular Risk in Digital Osteoarthritis (RICARDI)

University Hospital, Clermont-Ferrand

Status: Enrolling

Conditions: Osteoporosis; Radiculopathy Lumbar; Osteoarthritis Hand; Lumbago

Treatments: Other: X-ray absorptiometry (DXA); Other: hand ultrasound; Other: Intima media thickness ultrasound; Other: EndoPAT™ 2000 system

Study type: Interventional

Funder types: Other

Identifiers

NCT05923736

AOI 2022 MATHIEU

Details and patient eligibility

About

The goal of this cross-sectional case control study is to investigate the cardiovascular risk in digital osteoarthritis. This study aims to compare the cardiovascular risk between group of patients with digital osteoarthritis and control group of patients with non-osteoarthritis disease paired by measurement of carotid intima-media thickness. All participants will undergo an ultrasound scan to measure carotid intima media thickness, a clinical assessment with the rheumatologist and a cardiovascular risk assessment.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

For all subjects:

• Adult male or female subject
• Able to give informed consent to participate in research
• Affiliated with a Social Security plan

For the digital osteoarthritis group:

• Consultant in Rheumatology at Clermont-Ferrand University Hospital
• Affected by digital osteoarthritis meeting ACR diagnostic criteria with radiographic signs of osteoarthritis validated by a radiologist.

For the control group :

• Rheumatology consultant at the Clermont-Ferrand University Hospital or hospitalized in this department for a non-arthritic, non-rheumatic pathology.
• Patients with spinal disc pathology (lumbago, radiculalgia due to disco-radicular conflict) or non-severe osteoporosis, i.e. with a densitometric T score between -2.5 and -3 DS.

Exclusion criteria

For all topics :

• Refusal to participate
• Pregnant women, nursing mothers
• Subjects under guardianship or curatorship, deprived of liberty, or under court protection

For the digital osteoarthritis group:

• Existence of diagnostic arguments for another inflammatory rheumatism (rheumatoid arthritis, spondylarthritis, psoriatic arthritis, lupus, gout, chondrocalcinosis...) or another arthrosic localization (gonarthrosis, coxarthrosis, discarthrosis) symptomatic at the time of inclusion or affecting daily activities.

For the control group :

• Existence of chronic inflammatory rheumatism (rheumatoid arthritis, spondylitis, psoriatic arthritis, lupus, gout, chondrocalcinosis...)
• Existence of digital osteoarthritis
• Existence of another painful arthritic site (knee, hip, rachi) Existence of finger pain, whatever the etiology.

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Case group : digital osteoarthritis

Other group

Treatment:

Other: Intima media thickness ultrasound

Other: EndoPAT™ 2000 system

Other: X-ray absorptiometry (DXA)

Other: hand ultrasound

Control group : lumbago, osteoporosis

Other group

Treatment:

Other: Intima media thickness ultrasound

Other: EndoPAT™ 2000 system

Other: X-ray absorptiometry (DXA)

Other: hand ultrasound