Impact of Hand Osteoarthritis on Arterial Stiffness
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- carotid-femoral arterial stiffness
研究概览
简要总结
Patients affected by osteoarthritis (OA) have an increase overall mortality compared to the general population, mainly due to cardiovascular diseases. OA patients without cardiovascular risk have a 10 years cardiovascular events higher of around 15-30 %. Although the molecular mechanisms are still not well known, the structure and function of the vessel wall can be affected by several inflammatory and metabolic parameters during OA.These functional and structural changes of the arterial wall leads to arterial stiffness, measured by the pulse-wave velocity (PWV). PWV is the most widely used technique to assess arterial stiffness and has been shown to have predictive value for morbidity and mortality. In our study, we planned to compare arterial stiffness in OA patients with healthy subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with clinical hand OA defined according to the ACR (American College of Rheumatology) criteria.
- •Patients with radiographic hand OA defined according to the Kellgren
- •Lawrence criteria (≥ 2).
- •Steady dose of statins for at least one month.
- •Subject affiliated to a social security scheme
- •Written informed consent
排除标准
- •Rheumatoid arthritis, psoriatic arthritis or other inflammatory arthritis diseases.
- •History of arterial hypertension treated and / or uncontrolled (SBP > 140 mmHg and DBP (diastolic blood pressure) > 90 mmHg)
- •Diabetes (fasting blood glucose > 7 mmol/L)
- •Obesity (BMI > 35 kg/m²)
- •Chronic renal failure defined by a glomerular filtration rate <60 ml/min/1,73m ².
- •Patient with uncontrolled cardiovascular disease or a personal history of cardiovascular events (myocardial infarction and angina, occlusive arterial disease, stroke)
- •Pregnant or breastfeeding, or premenopausal and not taking an effective contraception
结局指标
主要结局
carotid-femoral arterial stiffness
时间窗: within the first 15 days after inclusion
To assess the carotid-femoral arterial stiffness determined by measuring the PWV in patients with hand OA compared to healthy subjects.
次要结局
未报告次要终点