Assessment of Inflammation Load, Endothelial and Cardiac Function Before and After Medical and Surgical Treatment in Inflammatory Bowel Diseases
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Change of CFR
Study Overview
Brief Summary
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.
Detailed Description
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 Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Patients with IBD diagnosed > 6 months via biopsy confirming the diagnosis
- •Patients with IBD at an advanced & non-controllable phase (IBD scores,clinical status, endoscopic and biochemical values) requiring the initiation of a new medical treatment or surgical intervention.
Exclusion Criteria
- •Coronary Artery Disease
- •Peripheral Arterial Disease
- •Thromboembolic Disease (acute or chronic)
- •Heart failure of any cause
- •Valvular Disease
- •Congenital Heart Defect
- •Heart Rhythm Disorder
- •Stroke, Renal or liver failure, malignancy, endocrine disorder
- •Other autoimmune disorder or angiitis
- •IBD diagnosed < 6 months
- •BMI > 40 Kg/m2
Outcomes
Primary Outcomes
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
Secondary Outcomes
No secondary outcomes reported
Investigators
Ignatios Ikonomidis
Associate Professor of Cardiology
University of Athens