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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03615287
Other study ID # 42/25-01-18
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 26, 2018
Est. completion date January 2022

Study information

Verified date July 2018
Source University of Athens
Contact Ignatios Ikonomidis, PhD
Phone +306944805732
Email ignoik@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 120
Est. completion date January 2022
Est. primary completion date January 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Greece ''Attikon'' University General Hospital Athens Attiki

Sponsors (1)

Lead Sponsor Collaborator
University of Athens

Country where clinical trial is conducted

Greece, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change of CFR Change of coronary flow reserve values in echocardiography pre & post treatment Just before treatment and four (4) months after treatment
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