Cardiovascular Risk in Digital Osteoarthritis

Not Applicable

Recruiting

• Conditions: Lumbago; Osteoporosis; Radiculopathy Lumbar; Osteoarthritis Hand
• Interventions: Other: Intima media thickness ultrasound; Other: hand ultrasound; Other: EndoPAT™ 2000 system; Other: X-ray absorptiometry (DXA)

• Registration Number: NCT05923736
• Lead Sponsor: University Hospital, Clermont-Ferrand

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-04
• Study First Submitted: 2023-06-15
• Study First Submitted QC: 2023-06-27
• Study First Posted: 2023-06-28
• Study Start: 2023-10-04
• Last Update Submitted: 2024-04-02
• Last Update Posted: 2024-04-03
• Primary Completion: 2025-10-04
• Study Completion: 2026-10-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Case group : digital osteoarthritis	hand ultrasound	-
Case group : digital osteoarthritis	Intima media thickness ultrasound	-
Control group : lumbago, osteoporosis	Intima media thickness ultrasound	-
Case group : digital osteoarthritis	EndoPAT™ 2000 system	-
Case group : digital osteoarthritis	X-ray absorptiometry (DXA)	-
Control group : lumbago, osteoporosis	hand ultrasound	-
Control group : lumbago, osteoporosis	EndoPAT™ 2000 system	-
Control group : lumbago, osteoporosis	X-ray absorptiometry (DXA)	-

Primary Outcome Measures

Name	Time	Method
Measurement of carotid intima-media thickness	20 minutes	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.

Secondary Outcome Measures

Name	Time	Method
Identify endothelial dysfunction in coronary arteries by reactive hyperemia index score	15 minutes	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 .
Measurement of bone mineral density and body mass composition by DXA	15 minutes	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.
Cardiovascular risk assessment by SCORE scale	10 minutes	The SCORE scale measures the percent risk of a fatal cardiovascular event at 10 years due to arteriosclerosis.
Physical performance assessment by measuring the distance covered in metres in 6 minutes over a 30-metre course	6 minutes	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

Trial Locations

Locations (1)

Chu Clermont Ferrand; 🇫🇷 Clermont-Ferrand, France