NCT03615287

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

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 120 (estimated)
• Sponsor: University of Athens · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Inflammatory Bowel Diseases

Timeline

• Start date: 2018-01-26
• Primary completion: 2020-01-01
• Completion: 2022-01-01
• First posted: 2018-08-03
• Last updated: 2018-08-03

Locations

1 site across 1 country: Greece