Assessment of Cardiovascular Risk in Digital Osteoarthritis: A Case-control Study.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Measurement of carotid intima-media thickness
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Measurement of carotid intima-media thickness
时间窗: 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.
次要结局
- Identify endothelial dysfunction in coronary arteries by reactive hyperemia index score(15 minutes)
- Measurement of bone mineral density and body mass composition by DXA(15 minutes)
- Cardiovascular risk assessment by SCORE scale(10 minutes)
- Physical performance assessment by measuring the distance covered in metres in 6 minutes over a 30-metre course(6 minutes)