Osteoporosis Clinical Trial
— RICARDIOfficial title:
Assessment of Cardiovascular Risk in Digital Osteoarthritis: A Case-control Study.
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.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | October 4, 2026 |
Est. primary completion date | October 4, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
France | Chu Clermont Ferrand | Clermont-Ferrand |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Clermont-Ferrand |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Measurement of carotid intima-media thickness | EIM is a non-invasive ultrasound technique in which an ultrasound-generating probe is conventionally placed opposite the right primitive carotid artery. By distinguishing between an inner layer, consisting of the intima and media, and the outer layer, the adventitia, the intima-media thickness can be assessed. | 20 minutes | |
Secondary | Cardiovascular risk assessment by SCORE scale | The SCORE scale measures the percent risk of a fatal cardiovascular event at 10 years due to arteriosclerosis. | 10 minutes | |
Secondary | Identify endothelial dysfunction in coronary arteries by reactive hyperemia index score | The EndoPAT™ 2000 device (Itamar medical) is an examination to detect endothelial dysfunction in coronary arteries using reactive hyperemia: Normal EndoScore™: RHI > 1.67; Abnormal EndoScore™: RHI = 1.67 . | 15 minutes | |
Secondary | Measurement of bone mineral density and body mass composition by DXA | Two-photon X-ray absorptiometry (DXA) is a method commonly used to measure bone density. The examination distinguishes between 3 measurements: mineral mass, lean mass and fat mass. | 15 minutes | |
Secondary | Physical performance assessment by measuring the distance covered in metres in 6 minutes over a 30-metre course | Patients walk in a rhythmic sequence for 6 minutes on a 30-metre distance,this assesses the muscular strength of the lower limbs and enables you to judge your physical level | 6 minutes |
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