Assessing Cardiovascular Dysfunction Pre- & Post-treatment in Inflammatory Bowel Diseases

Study Overview
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Brief Summary
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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
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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.

Official Title
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Assessment of Inflammation Load, Endothelial and Cardiac Function Before and After Medical and Surgical Treatment in Inflammatory Bowel Diseases

Conditions
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Inflammatory Bowel Diseases

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group A<br>40 subjects undergoing Medical Treatment | |
| Group B<br>40 subjects undergoing Surgical Treatment | |
| Group C<br>40 control subjects | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of CFR | Change of coronary flow reserve values in echocardiography pre & post treatment | Just before treatment and four (4) months after treatment |