Actively Recruiting
Assessment of Cardiovascular Risk in Digital Osteoarthritis: A Case-control Study
Led by University Hospital, Clermont-Ferrand · Updated on 2024-04-03
100
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating cardiovascular risk in people with digital osteoarthritis by comparing them to patients with non-osteoarthritis conditions. This cross-sectional case-control study measures carotid intima-media thickness to assess differences in cardiovascular risk between these groups. The study also involves clinical assessments with rheumatologists and evaluates cardiovascular health more broadly. Participants will undergo several procedures including an ultrasound scan to measure carotid intima-media thickness, a hand ultrasound to assess joint condition, and use of the EndoPAT™ 2000 system to detect coronary artery endothelial dysfunction. Bone mineral density and body composition will be measured by DXA scanning, and physical performance will be evaluated by a 6-minute walking test. These assessments help compare cardiovascular risk factors and joint health between the digital osteoarthritis group and control patients with spine or osteoporosis conditions. During the study, participants will have clinical evaluations by rheumatologists, various imaging and functional tests, and cardiovascular risk assessments using the SCORE scale. The main outcome is carotid intima-media thickness measured in about 20 minutes, alongside secondary measures including cardiovascular risk scores, endothelial function, bone density, and walking ability. The total participation involves these assessments to better understand cardiovascular risk in digital osteoarthritis. The study is sponsored by University Hospital, Clermont-Ferrand and runs until October 2026.
CONDITIONS
Brief Title
Cardiovascular Risk in Digital Osteoarthritis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult male or female subject
- Able to give informed consent to participate in research
- Affiliated with a Social Security plan
- For digital osteoarthritis group: Diagnosed with digital osteoarthritis meeting ACR criteria with radiographic signs validated by a radiologist
- For control group: Have spinal disc pathology (lumbago, radiculalgia) or non-severe osteoporosis with specific densitometric T score range
- Rheumatology consultant at Clermont-Ferrand University Hospital or hospitalized in this department for non-arthritic, non-rheumatic conditions
You will not qualify if you...
- Refusal to participate
- Pregnant women or nursing mothers
- Subjects under guardianship, deprived of liberty, or under court protection
- For digital osteoarthritis group: Diagnosis of other inflammatory rheumatism or symptomatic other arthrosic localization affecting daily activities
- For control group: Diagnosis of chronic inflammatory rheumatism, digital osteoarthritis, other painful arthritic sites, or finger pain regardless of cause
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo several diagnostic assessments to evaluate cardiovascular risk and bone health using non-invasive imaging and functional tests.
1 visit (in-person)
Trial Site Locations
Total: 1 location
1
Chu Clermont Ferrand
Clermont-Ferrand, France
Actively Recruiting
Research Team
L
Lise Laclautre
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
2
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