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

Inflammatory Bowel Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03615287
• Other study ID #: 42/25-01-18
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Inflammatory Bowel Diseases
• Intestinal Diseases

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