Assessing Cardiovascular Dysfunction Pre- & Post-treatment in Inflammatory Bowel Diseases
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|ClinicalTrials.gov Identifier: NCT03615287|
Recruitment Status : Unknown
Verified July 2018 by Ignatios Ikonomidis, University of Athens.
Recruitment status was: Recruiting
First Posted : August 3, 2018
Last Update Posted : August 3, 2018
|Condition or disease|
|Inflammatory Bowel Diseases|
The aim of this study is to compare medical and surgery treatment in IBD patients and healthy controls, by assessing the endothelial and cardiac function and the inflammation status.
In particular, three subject groups will be enrolled, as follows:
40 patients [Crohn's disease (CD) & ulcerative colitis (UC)] who will undergo medical treatment (Group A), 40 patients (CD & UC) who will undergo surgery (Group B) and a healthy control group (Group C) comprising 40 subjects.
Assessment of the inflammation load (CRP, WBC, IL-6, TNFa), the endothelial function (FMD, PWV, cIMT, endothelial glycocalyx) and the cardiac function - via echocardiographic parameters (systolic and diastolic echo values, tissue doppler imaging-GLS-strain rate) - will be carried out for every subject group in two phases: prior to treatment and four months after the treatment, as applicable.
The objective is to investigate whether there is a statistically significant reduction of endothelial and cardiac dysfunction following medical and surgery treatment in IBD patients as well as to examine associations across the three groups.
|Study Type :||Observational|
|Estimated Enrollment :||120 participants|
|Official Title:||Assessment of Inflammation Load, Endothelial and Cardiac Function Before and After Medical and Surgical Treatment in Inflammatory Bowel Diseases|
|Actual Study Start Date :||January 26, 2018|
|Estimated Primary Completion Date :||January 2020|
|Estimated Study Completion Date :||January 2022|
40 subjects undergoing Medical Treatment
40 subjects undergoing Surgical Treatment
40 control subjects
- Change of CFR [ Time Frame: Just before treatment and four (4) months after treatment ]Change of coronary flow reserve values in echocardiography pre & post treatment
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03615287
|Contact: Ignatios Ikonomidis, PhDemail@example.com|
|Contact: Charilaos Triantafyllou, MDfirstname.lastname@example.org|
|''Attikon'' University General Hospital||Recruiting|
|Athens, Attiki, Greece, 12462|
|Contact: Ignatios Ikonomidis, MD 00302105831264 email@example.com|
|Principal Investigator: Ignatios Ikonomidis, MD|
|Study Chair:||Ioannis Papaconstantinou, PhD||2nd Department of Surgery Aretaieion Hospital-University of Athens-Greece|