Cardiovascular Risk in Digital Osteoarthritis

NCT ID: NCT05923736

Last Updated: 2024-04-03

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-04
• Study Completion Date: 2026-10-04

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.

Conditions

Osteoarthritis Hand; Lumbago; Osteoporosis; Radiculopathy Lumbar

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Case group : digital osteoarthritis

Group Type: OTHER

Intima media thickness ultrasound

Intervention Type: OTHER

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.

hand ultrasound

Intervention Type: OTHER

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.

EndoPAT™ 2000 system

Intervention Type: OTHER

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.

X-ray absorptiometry (DXA)

Intervention Type: OTHER

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

Control group : lumbago, osteoporosis

Group Type: OTHER

Intima media thickness ultrasound

Intervention Type: OTHER

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.

hand ultrasound

Intervention Type: OTHER

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.

EndoPAT™ 2000 system

Intervention Type: OTHER

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.

X-ray absorptiometry (DXA)

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: 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

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Clermont-Ferrand

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sylvain Mathieu

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Clermont-Ferrand

Locations

Chu Clermont Ferrand

Clermont-Ferrand, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Lise Laclautre

Role: CONTACT

promo_interne_drci@chu-clermontferrand.fr

334.73.754.963

Facility Contacts

Lise Laclautre

Role: primary

promo_interne_drci@chu-clermontferrand.fr

Other Identifiers

AOI 2022 MATHIEU

Identifier Type: -

Identifier Source: org_study_id