Impact of Anti-TNF, Vedolizumab and Tofacitinib on Aortic Stiffness, Carotid Intima-media Thickness and Cardiovascular Risk of Patients With Ulcerative Colitis
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- variation of carotid intima media thickness (CIMT) between the 3 patient groups
研究概览
简要总结
An increased risk of cardiovascular (CV) diseases has been observed in patients with inflammatory bowel diseases (IBD). The impact of IBD drugs, such as anti-TNF, anti-integrins or anti-JAK, on the risk of CV events in IBD is remains unknown. Aortic pulse wave velocity (aPWV), a measure of aortic stiffness, and carotid intima media thickness (CIMT) are both predictors of cardiovascular events and are increased in patients with IBD. The investigators aimed to prospectively compare the CV risk, CIMT, arterial stiffness and biomarkers of endothelial dysfunction at baseline and after 3 and 12 months of anti-TNF, vedolizumab and tofacitinib.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •Ulcerative colitis evolving for at least 6 months,
- •Patient older than 18 years,
- •Initiating a treatment by infliximab, adalimumab, golimumab, vedolizumab or tofacitinib,
- •Written informed consent.
排除标准
- •Patients with anti-hypertensive, antiplatelet or lipid-lowering drugs without stable dosage within the 3 months before the study and over the study period,
- •Patients with a cardiovascular event such as myocardial infarction and stroke,
- •Diabetic patient,
- •Pregnant women,
- •people unable to give their consent to participate
研究组 & 干预措施
anti-TNF
干预措施: Aortic pulse wave velocity (Other)
anti-TNF
干预措施: carotid intima media thickness (CIMT) (Other)
vedolizumab
干预措施: Aortic pulse wave velocity (Other)
vedolizumab
干预措施: carotid intima media thickness (CIMT) (Other)
tofacitinib
干预措施: Aortic pulse wave velocity (Other)
tofacitinib
干预措施: carotid intima media thickness (CIMT) (Other)
结局指标
主要结局
variation of carotid intima media thickness (CIMT) between the 3 patient groups
时间窗: at the end of month 3
次要结局
未报告次要终点