NCT03615287

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 26, 2018

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 20, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

August 3, 2018

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2022

Completed
Last Updated

August 3, 2018

Status Verified

July 1, 2018

Enrollment Period

1.9 years

First QC Date

July 20, 2018

Last Update Submit

July 30, 2018

Conditions

Inflammatory Bowel Diseases

Outcome Measures

Primary Outcomes (1)

  • Change of CFR

    Change of coronary flow reserve values in echocardiography pre \& post treatment

    Just before treatment and four (4) months after treatment

Study Arms (3)

Group A

40 subjects undergoing Medical Treatment

Group B

40 subjects undergoing Surgical Treatment

Group C

40 control subjects

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

IBD patients

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

''Attikon'' University General Hospital

Athens, Attica, 12462, Greece

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Assessment of the inflammation load through analysis of the values of CRP, WBC, IL-6, TNFa

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Study Officials

  • Ioannis Papaconstantinou, PhD

    2nd Department of Surgery Aretaieion Hospital-University of Athens-Greece

    STUDY CHAIR

Central Study Contacts

Ignatios Ikonomidis, PhD

CONTACT

+306944805732ignoik@gmail.com

Charilaos Triantafyllou, MD

CONTACT

+306942202084chtriantaf@yahoo.gr

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Cardiology

Study Record Dates

First Submitted

July 20, 2018

First Posted

August 3, 2018

Study Start

January 26, 2018

Primary Completion

January 1, 2020

Study Completion

January 1, 2022

Last Updated

August 3, 2018

Record last verified: 2018-07

Locations

GR(1)