Cardiovascular Risk in Digital Osteoarthritis

NCT05923736 | Recruiting

• 1 other identifier: AOI 2022 MATHIEU
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Cardiovascular risk assessment by SCORE scale

  10 minutes

• Identify endothelial dysfunction in coronary arteries by reactive hyperemia index score

  15 minutes

• Measurement of bone mineral density and body mass composition by DXA

  15 minutes

• Physical performance assessment by measuring the distance covered in metres in 6 minutes over a 30-metre course

  6 minutes

Study Arms (2)

Case group : digital osteoarthritis

OTHER

Other: Intima media thickness ultrasound; Other: hand ultrasound; Other: EndoPAT™ 2000 system; Other: X-ray absorptiometry (DXA)

Control group : lumbago, osteoporosis

OTHER

Other: Intima media thickness ultrasound; Other: hand ultrasound; Other: EndoPAT™ 2000 system; Other: X-ray absorptiometry (DXA)

Interventions

Intima media thickness ultrasound 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.

Case group : digital osteoarthritis; Control group : lumbago, osteoporosis

hand ultrasound 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.

Case group : digital osteoarthritis; Control group : lumbago, osteoporosis

EndoPAT™ 2000 system 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.

Case group : digital osteoarthritis; Control group : lumbago, osteoporosis

X-ray absorptiometry (DXA) 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

Case group : digital osteoarthritis; Control group : lumbago, osteoporosis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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:
• 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.

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (1)

Chu Clermont Ferrand

Clermont-Ferrand, France

RECRUITING

MeSH Terms

Conditions

Low Back Pain; Osteoporosis

Interventions

Absorptiometry, Photon

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Radiography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Densitometry; Photometry; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Sylvain Mathieu

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lise Laclautre

CONTACT

334.73.754.963; promo_interne_drci@chu-clermontferrand.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 15, 2023
• First Posted: June 28, 2023
• Study Start: October 4, 2023
• Primary Completion: October 4, 2025
• Study Completion (Estimated): October 4, 2026
• Last Updated: April 3, 2024

Record last verified: 2023-04

Locations

FR (1)