Osteoarthritis HandRICARDINCT05923736
Cardiovascular Risk in Digital Osteoarthritis
A study testing Intima media thickness ultrasound, hand ultrasound and EndoPAT™ 2000 system in people with Osteoarthritis Hand and Lumbago, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis Hand, Lumbago, Osteoporosis
- What is being tested?
- Intima media thickness ultrasound, hand ultrasound and EndoPAT™ 2000 system
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 4 Oct 2023to 4 Oct 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Chu Clermont Ferrand
Clermont-Ferrand
Lise Laclautre, promo_interne_drci@chu-clermontferrand.fr
Sylvain Mathieu
About this study
Official title: 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.
- Conditions
- Osteoarthritis Hand, Lumbago, Osteoporosis, Radiculopathy Lumbar
- Being tested
- Intima media thickness ultrasound, hand ultrasound, EndoPAT™ 2000 system, X-ray absorptiometry (DXA)
- Medical subject headings
- Low Back Pain, Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intima media thickness ultrasoundOther
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 ultrasoundOther
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 systemOther
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
| Study group | Role | What they receive |
|---|---|---|
| Case group : digital osteoarthritis | Other | Not described Receives: Other: Intima media thickness ultrasound; Other: hand ultrasound; Other: EndoPAT™ 2000 system; Other: X-ray absorptiometry (DXA) |
| Control group : lumbago, osteoporosis | Other | Not described Receives: Other: Intima media thickness ultrasound; Other: hand ultrasound; Other: EndoPAT™ 2000 system; Other: X-ray absorptiometry (DXA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 20 minutes
Secondary outcomes (4)
Cardiovascular risk assessment by SCORE scale
The SCORE scale measures the percent risk of a fatal cardiovascular event at 10 years due to arteriosclerosis.
Measured: 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 .
Measured: 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.
Measured: 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
Measured: 6 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2023
- Study start4 Oct 2023
- Primary completion4 Oct 2025 (estimated)
- Study completion4 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis HandStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sylvain Mathieu, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05923736
- Sponsor's protocol ID
- AOI 2022 MATHIEU
- Acronym
- RICARDI
- Status last verified
- Apr 2023
- First submitted
- 15 Jun 2023
- Last updated
- 3 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Cardiovascular Risk in Digital Osteoarthritis: A Case-control Study.
- ClinicalTrials.gov ID
- NCT05923736
- Acronym / sponsor ID
- RICARDI / AOI 2022 MATHIEU
- Conditions
- Osteoarthritis Hand, Lumbago, Osteoporosis, Radiculopathy Lumbar
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 4 Oct 2023 (actual)
- Primary completion
- 4 Oct 2025 (estimated)
- Study completion
- 4 Oct 2026 (estimated)
- First posted
- 28 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
- Affected by digital osteoarthritis meeting ACR diagnostic criteria with radiographic signs of osteoarthritis validated by a radiologist.
Key exclusion criteria (10 listed)
- Refusal to participate
- Pregnant women, nursing mothers
- Subjects under guardianship or curatorship, deprived of liberty, or under court protection
- 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.
- Existence of chronic inflammatory rheumatism (rheumatoid arthritis, spondylitis, psoriatic arthritis, lupus, gout, chondrocalcinosis...)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intima media thickness ultrasoundEIM 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 | Case group : digital osteoarthritis, Control group : lumbago, osteoporosis |
| hand ultrasoundPerformed 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 | Case group : digital osteoarthritis, Control group : lumbago, osteoporosis |
| EndoPAT™ 2000 systemIt'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 | Case group : digital osteoarthritis, Control group : lumbago, osteoporosis |
| 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 | Case group : digital osteoarthritis, Control group : lumbago, osteoporosis |
Primary outcome
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.
4 secondary outcomes
Cardiovascular risk assessment by SCORE scale
Time frame: 10 minutes
Identify endothelial dysfunction in coronary arteries by reactive hyperemia index score
Time frame: 15 minutes
Measurement of bone mineral density and body mass composition by DXA
Time frame: 15 minutes
Physical performance assessment by measuring the distance covered in metres in 6 minutes over a 30-metre course
Time frame: 6 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sylvain Mathieu principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intima media thickness ultrasound, hand ultrasound and EndoPAT™ 2000 system in people with Osteoarthritis Hand and Lumbago, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lise Laclautre (334.73.754.963, promo_interne_drci@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of carotid intima-media thickness (time frame: 20 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2024.