Anti TNF α Improves Endothelial Dysfunction in IBD Patients
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- This study will assessed the presence of endothelial dysfunction in patients, C with crohn's disease before and after 12 weeks treatment of anti TNF α. CDAI, CRP.
研究概览
简要总结
Study hypothesis - this study will assess the presence of endothelial dysfunction in patients with Crohn's disease before and after 12 weeks treatment of anti TNF α.
详细描述
Crohn's Disease (CD) is a life long disease that mainly affects young adults. There is evidence That gut tissue injury is the result of an abnormal immune response that involved multiple non immune cellular systems including the intestinal microvascular endothelial cell. Moreover, clinical studies have shown that 1-7% of irritable bowel disease (IBD) patients suffer from arterial and venous thromboembolic complication.
Chronic inflammation has a major role in the development and propagation of endothelial dysfunction, which can lead to coronary artery disease.
Endothelial dysfunction has been described in patients with various and diverse chronic inflammatory conditions. Over the last few years, dysfunction of vascular endothelium has been widely recognized as the first step in the development of atherosclerosis. Several inflammatory mediators, such as C-reactive protein (CRP), Tumor Necrosis Factor α, (TNF α), nitric oxide (NO), vascular endothelial growth factor, CD-40, interleukin-6 (IL-6), which are up-regulated in IBD, also are known to impact vascular impact.
The normal endothelium produces a vasodilatatory response to ischemia referred to us as reactive hyperemia. Shear stress on the blood vessel wall leads to the production and release vasodilatation. With endothelial dysfunction there is often either a blunted vasodilatatory in response to ischemic event, and chronic inflammation.
The hypothesis of this study is that patients with Crohn's disease have an increased incidence of endothelial dysfunction, which can be corrected or improved by treatment with anti TNF α.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Non smoker
- •No history of IHD or other known risk factors for IHD
排除标准
- •Patients who had been treated with anti TNF α 4 weeks before the study
- •As well as those who received corticosteroids within 1 week before the study.
- •DM, IHD, CRF, SMOKER
研究组 & 干预措施
endothelial dysfunction assessment
This study is a one arm study . In this arm we will assess endothelial function (with Endopath device) in patients with Crohn's disease, before and after treatment of anti TNF α and other medication, and evaluate the possible role of tumor necrosis factor (TNF)-α in the pathophysiology of this abnormality.
干预措施: Endopath from Itamar medical - FDA approved device. (Device)
endothelial dysfunction assessment
This study is a one arm study . In this arm we will assess endothelial function (with Endopath device) in patients with Crohn's disease, before and after treatment of anti TNF α and other medication, and evaluate the possible role of tumor necrosis factor (TNF)-α in the pathophysiology of this abnormality.
干预措施: Anti TNF Alfa. (Drug)
结局指标
主要结局
This study will assessed the presence of endothelial dysfunction in patients, C with crohn's disease before and after 12 weeks treatment of anti TNF α. CDAI, CRP.
时间窗: 12 month
In this study we will preformed an endothelial function test before and after 12 weeks of treatment, by Endopath device from Itamar medical, FDA approved. Endo-PAT tests can be carried out in both the office and hospital settings, with patients positioned either sitting or supine. Endo-PAT bio-sensors are placed on the index fingers of both arms. The test takes 15 minutes to complete, is very easy to perform, and is both operator and interpreter independent. Thermo-neutral, quiet surroundings are recommended. Endo-PAT quantifies the endothelium-mediated changes in vascular tone, elicited by a 5-minute occlusion of the brachial artery (using a standard blood pressure cuff).
次要结局
未报告次要终点