|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
19 February 2015 |
|
Main ID: |
NCT01881464 |
|
Date of registration:
|
11/06/2013 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
Anti TNF a Improves Endothelial Dysfunction in IBD Patients
|
|
Scientific title:
|
Anti TNF a Improves Endothelial Dysfunction in IBD Patients |
|
Date of first enrolment:
|
May 2014 |
|
Target sample size:
|
20 |
|
Recruitment status: |
Recruiting |
|
URL:
|
http://clinicaltrials.gov/show/NCT01881464 |
|
Study type:
|
Observational |
|
Study design:
|
Observational Model: Cohort, Time Perspective: Prospective
|
|
Phase:
|
|
|
|
Countries of recruitment
|
|
Israel
| | | | | | | |
|
Contacts
|
|
Name:
|
zittan Eran, M.D |
|
Address:
|
|
|
Telephone:
|
972-48250359 |
|
Email:
|
eranzittan@gmail.com |
|
Affiliation:
|
|
|
|
Name:
|
Zittan Eran |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
CARMEL MEDICAL CENTER - HAIFA -ISRAEL |
| |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- Non smoker
- No history of IHD or other known risk factors for IHD
Exclusion Criteria:
- Patients who had been treated with anti TNF a 4 weeks before the study
- As well as those who received corticosteroids within 1 week before the study.
- DM, IHD, CRF, SMOKER
Age minimum:
18 Years
Age maximum:
40 Years
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Crohn's Disease
|
|
Intervention(s)
|
|
Drug: Anti TNF Alfa.
|
|
Device: Endopath from Itamar medical - FDA approved device.
|
|
Primary Outcome(s)
|
|
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 a. CDAI, CRP.
[Time Frame: 12 month]
|
|
Secondary ID(s)
|
|
CMC-13-0006-CTIL
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|