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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03615287

Enrollment

120

Registered

2018-08-03

Start date

2018-01-26

Completion date

2022-01-31

Last updated

2018-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inflammatory Bowel Diseases

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.

Interventions

None listed

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

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

Countries

Greece

Contacts

Primary ContactIgnatios Ikonomidis, PhD

ignoik@gmail.com+306944805732

Backup ContactCharilaos Triantafyllou, MD

chtriantaf@yahoo.gr+306942202084

Outcome results