Clinical trial NCT05923736: Cardiovascular Risk in Digital Osteoarthritis
Official title: Assessment of Cardiovascular Risk in Digital Osteoarthritis: A Case-control Study.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Osteoarthritis Hand
Lumbago
Osteoporosis
Radiculopathy Lumbar
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2023-06-28
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: It's a cross-sectional case-control study. The study will include patients with digital osteoarthritis as case group and patients with lumbago and osteoporosis without a inflammatory arthritis as control group.Imaging exams will be added for research purposes, and are not part of routine care or diagnosis of these conditions: intima-media thickness, arterial compliance and arterial composition; these tests involve minimal risk.
Primary purpose: OTHER

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Measurement of carotid intima-media thickness
timeFrame: 20 minutes
Secondary outcomes:
measure: Cardiovascular risk assessment by SCORE scale
timeFrame: 10 minutes
measure: Identify endothelial dysfunction in coronary arteries by reactive hyperemia index score
timeFrame: 15 minutes
measure: Measurement of bone mineral density and body mass composition by DXA
timeFrame: 15 minutes
measure: Physical performance assessment by measuring the distance covered in metres in 6 minutes over a 30-metre course
timeFrame: 6 minutes
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: Chu Clermont Ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Sylvain Mathieu
role: PRINCIPAL_INVESTIGATOR
References: