Health TrialsbyHealthPanel

Cardiovascular Risk in Digital Osteoarthritis

ConditionsOsteoarthritis HandLumbagoOsteoporosisRadiculopathy Lumbar
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Clermont-Ferrand

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adult male or female subject

Able to give informed consent to participate in research

Affiliated with a Social Security plan

Consultant in Rheumatology at Clermont-Ferrand University Hospital

Disqualifiers

Refusal to participate

Pregnant women, nursing mothers

Subjects under guardianship or curatorship, deprived of liberty, or under court protection

Existence of chronic inflammatory rheumatism (rheumatoid arthritis, spondylitis, psoriatic arthritis, lupus, gout, chondrocalcinosis...)

Trial design

Design model

Single group

Treatments tested in this trial

  • Intima media thickness ultrasound

    Other intervention

    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 intervention

    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 intervention

    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 intervention

    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

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Case group : digital osteoarthritisOther 4 interventions
Group B: Control group : lumbago, osteoporosisOther 4 interventions

Trial outcomes

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.

Time frame
20 minutes

Secondary outcomes

1

Cardiovascular risk assessment by SCORE scale

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

Time frame
10 minutes
2

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 .

Time frame
15 minutes
3

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.

Time frame
15 minutes
4

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

Time frame
6 minutes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital, Clermont-Ferrand

Lead sponsor

Source ClinicalTrials.gov
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