Back to resultsCardiovascular Risk in Digital Osteoarthritis (RICARDI)
Primary Purpose
Osteoarthritis Hand, Lumbago, Osteoporosis
Status
Not yet recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Intima media thickness ultrasound
hand ultrasound
EndoPAT™ 2000 system
X-ray absorptiometry (DXA)
Sponsored by
About this trial
This is an interventional other trial for Osteoarthritis Hand
Eligibility Criteria
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.
Sites / Locations
- Chu Clermont Ferrand
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Case group : digital osteoarthritis
Control group : lumbago, osteoporosis
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Cardiovascular risk assessment by SCORE scale
The SCORE scale measures the percent risk of a fatal cardiovascular event at 10 years due to arteriosclerosis.
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 .
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.
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
Full Information
NCT ID
NCT05923736
First Posted
June 15, 2023
Last Updated
June 27, 2023
Sponsor
University Hospital, Clermont-Ferrand
1. Study Identification
Unique Protocol Identification Number
NCT05923736
Brief Title
Cardiovascular Risk in Digital Osteoarthritis
Acronym
RICARDI
Official Title
Assessment of Cardiovascular Risk in Digital Osteoarthritis: A Case-control Study.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 15, 2023 (Anticipated)
Primary Completion Date
September 15, 2025 (Anticipated)
Study Completion Date
September 15, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Clermont-Ferrand
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis Hand, Lumbago, Osteoporosis, Radiculopathy Lumbar
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
Non-Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Case group : digital osteoarthritis
Arm Type
Other
Arm Title
Control group : lumbago, osteoporosis
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
Intima media thickness ultrasound
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
hand ultrasound
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
EndoPAT™ 2000 system
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
X-ray absorptiometry (DXA)
Intervention Description
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 Outcome Measure Information:
Title
Measurement of carotid intima-media thickness
Description
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 Outcome Measure Information:
Title
Cardiovascular risk assessment by SCORE scale
Description
The SCORE scale measures the percent risk of a fatal cardiovascular event at 10 years due to arteriosclerosis.
Time Frame
10 minutes
Title
Identify endothelial dysfunction in coronary arteries by reactive hyperemia index score
Description
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
Title
Measurement of bone mineral density and body mass composition by DXA
Description
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
Title
Physical performance assessment by measuring the distance covered in metres in 6 minutes over a 30-metre course
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lise Laclautre
Phone
334.73.754.963
Email
promo_interne_drci@chu-clermontferrand.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sylvain Mathieu
Organizational Affiliation
University Hospital, Clermont-Ferrand
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chu Clermont Ferrand
City
Clermont-Ferrand
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lise Laclautre
Email
promo_interne_drci@chu-clermontferrand.fr
First Name & Middle Initial & Last Name & Degree
Sylvain Mathieu
12. IPD Sharing Statement
Learn more about this trial
Cardiovascular Risk in Digital Osteoarthritis
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