Anti TNF α Improves Endothelial Dysfunction in IBD Patients
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01881464|
Recruitment Status : Recruiting
First Posted : June 19, 2013
Last Update Posted : May 16, 2014
|Condition or disease||Intervention/treatment||Phase|
|Crohn's Disease||Device: Endopath from Itamar medical - FDA approved device. Drug: Anti TNF Alfa.||Phase 4|
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.
The purpose of our study was to assess endothelial function in patients with Crohn's Disease, before and after treatment (steroids, immunomodulators, and anti TNF α). This study assessed the presence of endothelial dysfunction in patients with Crohn's disease and evaluated the possible role of tumor necrosis factor (TNF)-α in the pathophysiology of this abnormality.
In this study we will preformed an endothelial function test before and after treatment by Endopath device from Itamar medical, FDA approved.
Safety- Each subject will be screened by clinical history, physical examination, electrocardiogram, chest X-ray, Mantoux test (PPD), routine chemical analysis, and biomarkers.
The study protocol has been approved by the local institutional review board.
|Study Type :||Observational|
|Estimated Enrollment :||20 participants|
|Official Title:||Anti TNF α Improves Endothelial Dysfunction in IBD Patients|
|Study Start Date :||May 2014|
|Estimated Primary Completion Date :||June 2014|
|Estimated Study Completion Date :||June 2018|
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.
Device: Endopath from Itamar medical - FDA approved device.
endothelial function assessment by Endopath deviceDrug: Anti TNF Alfa.
This study will assessed the presence of endothelial dysfunction in patients with Crohn's disease before and after 12 weeks treatment of anti TNF α.
Other Name: HUMIRA-ADALIMUMAB, REMICADE-INFLIXIMAB
- 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. [ Time Frame: 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).
Biospecimen Retention: Samples Without DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01881464
|Contact: zittan Eran, M.Demail@example.com|
|Contact: Segol Ori, M.D||972-4-8250359||Ori_Segol@clalit.org.il|
|Carmel Medical Center||Recruiting|
|Principal Investigator: ZITTAN ERAN, M.D|
|Principal Investigator:||Zittan Eran||CARMEL MEDICAL CENTER - HAIFA -ISRAEL|