Anti TNF α Improves Endothelial Dysfunction in Crohns' Disease Patients

This study is currently recruiting participants.
Verified June 2013 by Carmel Medical Center
Sponsor:
Information provided by (Responsible Party):
Carmel Medical Center
ClinicalTrials.gov Identifier:
NCT01881464
First received: June 11, 2013
Last updated: June 18, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention Phase
Crohn's Disease
Device: Endopath from Itamar medical - FDA approved device.
Drug: Anti TNF Alfa.
Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Anti TNF α Improves Endothelial Dysfunction in Crohns' Disease Patients

Resource links provided by NLM:


Further study details as provided by Carmel Medical Center:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

    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).



Estimated Enrollment: 20
Study Start Date: June 2013
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 device
Drug: 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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 20 Crohns patients with CDAI 150-450
  • Non smoker
  • No history of IHD
  • Diabetes
  • Obesity
  • HTN
  • Vasculitis

Exclusion Criteria:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01881464

Contacts
Contact: zittan Eran, M.D 972-48250359 eranzittan@gmail.com
Contact: Segol Ori, M.D 972-4-8250359 Ori_Segol@clalit.org.il

Locations
Israel
Carmel Medical Center Recruiting
Haifa, Israel
Principal Investigator: ZITTAN ERAN, M.D         
Sponsors and Collaborators
Carmel Medical Center
Investigators
Principal Investigator: Zittan Eran CARMEL MEDICAL CENTER - HAIFA -ISRAEL
  More Information

No publications provided

Responsible Party: Carmel Medical Center
ClinicalTrials.gov Identifier: NCT01881464     History of Changes
Other Study ID Numbers: CMC-13-0006-CTIL
Study First Received: June 11, 2013
Last Updated: June 18, 2013
Health Authority: Israel: Ministry of Health

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on April 14, 2014