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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03615287
Recruitment Status : Unknown
Verified July 2018 by Ignatios Ikonomidis, University of Athens.
Recruitment status was:  Recruiting
First Posted : August 3, 2018
Last Update Posted : August 3, 2018
Sponsor:
Information provided by (Responsible Party):
Ignatios Ikonomidis, University of Athens

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.

Condition or disease
Inflammatory Bowel Diseases

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.

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Study Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Assessment of Inflammation Load, Endothelial and Cardiac Function Before and After Medical and Surgical Treatment in Inflammatory Bowel Diseases
Actual Study Start Date : January 26, 2018
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2022

Group/Cohort
Group A
40 subjects undergoing Medical Treatment
Group B
40 subjects undergoing Surgical Treatment
Group C
40 control subjects



Primary Outcome Measures :
  1. Change of CFR [ Time Frame: Just before treatment and four (4) months after treatment ]
    Change of coronary flow reserve values in echocardiography pre & post treatment


Biospecimen Retention:   Samples Without DNA
Assessment of the inflammation load through analysis of the values of CRP, WBC, IL-6, TNFa


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
IBD patients
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03615287


Contacts
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Contact: Ignatios Ikonomidis, PhD +306944805732 ignoik@gmail.com
Contact: Charilaos Triantafyllou, MD +306942202084 chtriantaf@yahoo.gr

Locations
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Greece
''Attikon'' University General Hospital Recruiting
Athens, Attiki, Greece, 12462
Contact: Ignatios Ikonomidis, MD    00302105831264    ignoik@gmail.com   
Principal Investigator: Ignatios Ikonomidis, MD         
Sponsors and Collaborators
University of Athens
Investigators
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Study Chair: Ioannis Papaconstantinou, PhD 2nd Department of Surgery Aretaieion Hospital-University of Athens-Greece
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Responsible Party: Ignatios Ikonomidis, Associate Professor of Cardiology, University of Athens
ClinicalTrials.gov Identifier: NCT03615287    
Other Study ID Numbers: 42/25-01-18
First Posted: August 3, 2018    Key Record Dates
Last Update Posted: August 3, 2018
Last Verified: July 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Intestinal Diseases
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis