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NCT Number: NCT05923736

Cardiovascular Risk in Digital Osteoarthritis

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.

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Key information

Conditions

Osteoarthritis Hand Back Pain Bone Diseases Bone Diseases, Metabolic Low Back Pain Lumbago Metabolic Diseases Musculoskeletal Diseases Neurologic Manifestations Nutritional and Metabolic Diseases Osteoporosis Pain Pathological Conditions, Signs and Symptoms Radiculopathy Lumbar Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chu Clermont Ferrand

Clermont-Ferrand, France

Location status: Recruiting

Location contact

Lise Laclautre

CONTACT

[email protected]

Sylvain Mathieu

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

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.

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

Primary outcomes

  1. Measurement of carotid intima-media thickness

    Time frame: 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 outcomes

  1. Cardiovascular risk assessment by SCORE scale

    Time frame: 10 minutes

    The SCORE scale measures the percent risk of a fatal cardiovascular event at 10 years due to arteriosclerosis.

  2. Identify endothelial dysfunction in coronary arteries by reactive hyperemia index score

    Time frame: 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 .

  3. Measurement of bone mineral density and body mass composition by DXA

    Time frame: 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.

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

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Lise Laclautre

CONTACT

[email protected]

334.73.754.963

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Registry information

Official study title

Assessment of Cardiovascular Risk in Digital Osteoarthritis: A Case-control Study.

Acronym: RICARDI

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Jun 28, 2023
Registry last updated
Apr 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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