Inflammatory Bowel DiseasesNCT03615287
Assessing Cardiovascular Dysfunction Pre- & Post-treatment in Inflammatory Bowel Diseases
An observational study of Inflammatory Bowel Diseases, run by University of Athens at 1 site in Greece.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Inflammatory Bowel Diseases
- How many people
- 120 participants
- Where
- 1 siteGreece
- Study dates
- 26 Jan 2018to Jan 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: IBD patients
Who may be able to join
- 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.
Who cannot join
- Coronary Artery Disease
- Peripheral Arterial Disease
- Thromboembolic Disease (acute or chronic)
- Heart failure of any cause
- Valvular Disease
- Congenital Heart Defect
Show all 11Show fewer
- Heart Rhythm Disorder
- Stroke, Renal or liver failure, malignancy, endocrine disorder
- Other autoimmune disorder or angiitis
- IBD diagnosed < 6 months
- BMI > 40 Kg/m2
Trial locations and contacts
1 site in 1 country.
Greece1 site, 1 recruiting
- Recruiting
''Attikon'' University General Hospital
Athens, Attica, 12462
Ignatios Ikonomidis, MD, 00302105831264, ignoik@gmail.com
Ignatios Ikonomidis, MD
About this study
Official title: Assessment of Inflammation Load, Endothelial and Cardiac Function Before and After Medical and Surgical Treatment in Inflammatory Bowel Diseases
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.
Read the 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
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group A | 40 subjects undergoing Medical Treatment | |
| Group B | 40 subjects undergoing Surgical Treatment | |
| Group C | 40 control subjects |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of CFR
Change of coronary flow reserve values in echocardiography pre \& post treatment
Measured: Just before treatment and four (4) months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2018
- Study start26 Jan 2018
- Primary completionJan 2020 (estimated)
- Study completionJan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Athens
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ignatios Ikonomidis, University of Athens
- Investigators
- Ioannis Papaconstantinou, PhD, Study chair, 2nd Department of Surgery Aretaieion Hospital-University of Athens-Greece
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03615287
- Sponsor's protocol ID
- 42/25-01-18
- Status last verified
- Jul 2018
- First submitted
- 20 Jul 2018
- Last updated
- 3 Aug 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Inflammation Load, Endothelial and Cardiac Function Before and After Medical and Surgical Treatment in Inflammatory Bowel Diseases
- ClinicalTrials.gov ID
- NCT03615287
- Acronym / sponsor ID
- 42/25-01-18
- Conditions
- Inflammatory Bowel Diseases
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of AthensUniversity, hospital or other
- Study start
- 26 Jan 2018 (actual)
- Primary completion
- Jan 2020 (estimated)
- Study completion
- Jan 2022 (estimated)
- First posted
- 3 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | – | –40 subjects undergoing Medical Treatment |
| Group B | – | –40 subjects undergoing Surgical Treatment |
| Group C | – | –40 control subjects |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- IBD patients
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (11 listed)
- Coronary Artery Disease
- Peripheral Arterial Disease
- Thromboembolic Disease (acute or chronic)
- Heart failure of any cause
- Valvular Disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ioannis Papaconstantinou, PhD study chair
2nd Department of Surgery Aretaieion Hospital-University of Athens-Greece
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammatory Bowel Diseases, run by University of Athens at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ignatios Ikonomidis, PhD (+306944805732, ignoik@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of CFR (time frame: Just before treatment and four (4) months after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2018.