2024-517314-15-00招募中4 期
IMPACT OF ANTI-TNF, VEDOLIZUMAB AND TOFACITINIB ON AORTIC STIFFNESS, CAROTID INTIMA-MEDIA THICKNESS AND CARDIOVASCULAR RISK OF PATIENTS WITH ULCERATIVE COLITIS
适应症
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
- Carotid intima media thickness (CIMT)
研究概览
简要总结
To compare the CIMT after 3 months of therapy in ulcerative colitis in patients treated by anti-TNF, vedolizumab, and tofacitinib
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 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
- •Patient covered by French national health insurance
- •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 or breastfeeding
- •Patient deprived of liberty by administrative or judicial decision or placed under judicial protection (guardianship or supervision)
结局指标
主要结局
Carotid intima media thickness (CIMT)
Carotid intima media thickness (CIMT)
次要结局
- Aortic pulse wave velocity (aPWV) / arterial stiffness
- Augmentation index (AIx)
- Framingham score, the 10-year atherosclerotic CV disease risk (ASCVD) indices (reflect of the cardiovascular risk) and the SCORE score
- Ulcerative colitis activity score /Mayo Score
- Lipids parameters (HDL, LDL, TC, TG)
- Arterial tension and systolic pressure index
- Endothelial function / Coagulation parameters
研究者
FUMERY MATHURIN
Scientific
Centre Hospitalier Universitaire Amiens Picardie
研究点 (1)
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