Cardiovascular Risk in Digital Osteoarthritis (RICARDI)

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.

Study Overview

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

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lise Laclautre; Phone Number: 334.73.754.963; Email: promo_interne_drci@chu-clermontferrand.fr

Study Locations

• France
  • Clermont-Ferrand, France
    • Recruiting
    • Chu Clermont Ferrand
    • Contact: Lise Laclautre; Email: promo_interne_drci@chu-clermontferrand.fr
    • Principal Investigator: Sylvain MATHIEU

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Case group : digital osteoarthritis	Other: Intima media thickness ultrasound; EIM is a non-invasive ultrasound technique in which an ultrasound-generating probe is conventionally placed opposite the right primary 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.; Other: hand ultrasound; Performed by the rheumatologist, to quantify the number of synovial thickenings in B mode and the number of synovitis in Doppler mode. The presence or absence of joint erosions on the metacarpophalangeal (MCP), proximal interphalangeal (PPI) or distal interphalangeal (DIP) joints.; Other: EndoPAT™ 2000 system; It's a measurement that detects endothelial dysfunction in coronary arteries using reactive hyperemia.This examination will be carried out in accordance with the manufacturer's instructions by the Rheumatology Department nurse. The patient lies down for the duration of the examination (20 minutes). A probe is placed on the index finger of each hand and a cuff on the left arm. Recording begins with a 5-minute baseline period (at rest), followed by a 5-minute period of arm occlusion, and ends with a 5-minute period of return to normal.; Other: X-ray absorptiometry (DXA); This X-ray examination will be carried out on the Hologic device and the analyses by APEX 4.0 software. Two-photon X-ray absorptiometry (DXA) is a method commonly used to measure bone mineral density. It is based on a scan of the body by an X-ray beam at 2 different energy levels, which enables 3 compartments to be individualized: mineral mass, lean mass and fat mass. This low-radiation method (less than a conventional chest X-ray) is regarded as a benchmark for accurate measurement of both bone mineral density and the various body compartments. The examination lasts 10 minutes and is carried out by the department's electroradiology manipulators
Other: Control group : lumbago, osteoporosis	Other: Intima media thickness ultrasound; EIM is a non-invasive ultrasound technique in which an ultrasound-generating probe is conventionally placed opposite the right primary 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.; Other: hand ultrasound; Performed by the rheumatologist, to quantify the number of synovial thickenings in B mode and the number of synovitis in Doppler mode. The presence or absence of joint erosions on the metacarpophalangeal (MCP), proximal interphalangeal (PPI) or distal interphalangeal (DIP) joints.; Other: EndoPAT™ 2000 system; It's a measurement that detects endothelial dysfunction in coronary arteries using reactive hyperemia.This examination will be carried out in accordance with the manufacturer's instructions by the Rheumatology Department nurse. The patient lies down for the duration of the examination (20 minutes). A probe is placed on the index finger of each hand and a cuff on the left arm. Recording begins with a 5-minute baseline period (at rest), followed by a 5-minute period of arm occlusion, and ends with a 5-minute period of return to normal.; Other: X-ray absorptiometry (DXA); This X-ray examination will be carried out on the Hologic device and the analyses by APEX 4.0 software. Two-photon X-ray absorptiometry (DXA) is a method commonly used to measure bone mineral density. It is based on a scan of the body by an X-ray beam at 2 different energy levels, which enables 3 compartments to be individualized: mineral mass, lean mass and fat mass. This low-radiation method (less than a conventional chest X-ray) is regarded as a benchmark for accurate measurement of both bone mineral density and the various body compartments. The examination lasts 10 minutes and is carried out by the department's electroradiology manipulators

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: University Hospital, Clermont-Ferrand
• Investigators: Principal Investigator: Sylvain MATHIEU, University Hospital, Clermont-Ferrand

Study record dates

Study Major Dates

• Study Start (Actual): October 4, 2023
• Primary Completion (Estimated): October 4, 2025
• Study Completion (Estimated): October 4, 2026

Study Registration Dates

• First Submitted: June 15, 2023
• First Submitted That Met QC Criteria: June 27, 2023
• First Posted (Actual): June 28, 2023

Study Record Updates

• Last Update Posted (Actual): April 3, 2024
• Last Update Submitted That Met QC Criteria: April 2, 2024
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Nervous System Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Neuromuscular Diseases; Peripheral Nervous System Diseases; Bone Diseases; Bone Diseases, Metabolic; Osteoarthritis; Osteoporosis; Radiculopathy
• Other Study ID Numbers: AOI 2022 MATHIEU

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No