Assessing Cardiovascular Dysfunction Pre- & Post-treatment in Inflammatory Bowel Diseases
NCT ID: NCT03615287
Last Updated: 2018-08-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
120 participants
OBSERVATIONAL
2018-01-26
2022-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Self-care in Patients Affected by Inflammatory Bowel Disease and Caregivers' Contribution to Self-care
NCT06015789
Estimation of Cardiovascular Risk in Patients With Crohn's Disease and Ulcerative Colitis (PROVACI)
NCT07095634
Monitoring of Patients With Inflammatory Bowel Diseases: the Experience of the Reference Center of the Emilia-Romagna
NCT06721767
Predictors of Mucosal Healing in Inflammatory Bowel Disease (IBD) Patients Treated With Anti-TNF
NCT01605175
Patient Attitudes and Preferences for Outcomes of Inflammatory Bowel Disease Therapeutics
NCT02316678
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
OTHER
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Group A
40 subjects undergoing Medical Treatment
No interventions assigned to this group
Group B
40 subjects undergoing Surgical Treatment
No interventions assigned to this group
Group C
40 control subjects
No interventions assigned to this group
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Athens
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Ignatios Ikonomidis
Associate Professor of Cardiology
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Ioannis Papaconstantinou, PhD
Role: STUDY_CHAIR
2nd Department of Surgery Aretaieion Hospital-University of Athens-Greece
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
''Attikon'' University General Hospital
Athens, Attica, Greece
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
42/25-01-18
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.