Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07663201

Cardiovascular Risk in Patients With IBD

In this study our Research Hospital San Donato Policlinic ask your partipation with the aim to evaluate the risk of cardiovascular complication (i.e. stroke, myocardial infarction) in patients with inflammatory bowel disease. Multiple parameters (therapy, disease activity, life style) and investigations (DNA, stool, lab tests) will be evaluate with the support of artificial intelligence methodologies to better define the cardiovascular risk.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

About this study

Emerging evidence points to shared pathophysiological mechanisms between IBD and Cardiovascular disease (CVD), including genetic overlap (e.g., NOD2, CDKN2B, stromelysin, and ApoE polymorphisms), shared environmental triggers like smoking, and convergent immune pathways Disruption of both intestinal epithelial and vascular endothelial barriers through cytokines like TNF-a may provide a mechanistic link between gut inflammation and vascular pathology. In addition, gut microbiota alterations commonly seen in IBD have been implicated in the pathogenesis of cardiovascular conditions such as atherosclerosis.

There is still an unmet need to evaluate the real amount of CV risk in patients with IBD because of the lack of prospective trials, and the limitation of the available CV risk scores designed for an older background population compared to the patients with IBD. In addition, there is a lack of a systematic and combined evaluation of other possible shared risk factors, such as genetic polymorphisms or dysbiosis, and more importantly, the need to evaluate the full systematic dataset prospectively and with a hypothesis-free powerful methodology, such as artificial intelligence (AI)-driven algorithms.

Our first objective is to prospectively evaluate the occurrence of MACEs in a large cohort (±300) of IBD patients enrolled within the Unit of Gastroenterology of the IRCCS San Donato Policlinic, San Donato Milanese (Mi), and followed for 2 years. The occurrence of MACEs will be compared as a whole or individually with those of an age/gender-matched cohort under follow-up at the Unit of Cardiology of the same Institution in the CV PREVITAL study (NCT053399841). The occurrence of the MACEs in IBD patients will be evaluated by the PI and collaborators during the periodic control visit that will occurred at least after one and 2 years since the enrolling in this study, but that usually occur also more frequently (every 3-6 months) according to the underlying condition of IBD.

The secondary objectives will be to correlate the clinical characteristics of IBD patients (disease activity, therapy, etc.) and to undertake an extensive multi-omics, metabolic, and histological evaluation to identify additional risk factors which might increase the occurrence of MACES as compared to control population.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Established diagnosis of ulcerative colitis and Crohn's disease

Exclusion criteria

Age > 18 years Not compliant with study protocol

Treatment and study plan

Primary outcomes

  1. Major cardiovascular events

    Time frame: 2 years

    Stroke, myocardial infarction, atrial fibrillation, ischemic heart disease, cardiovascular death, arterial embolism

Study contacts

Contact information is provided by the study sponsor or research team.

Antonella Bianchi, Study Coordinator

CONTACT

[email protected]

0039 02 5277 4951

Vito Annese, Prof. PI

CONTACT

[email protected]

+39 2 5277 4722

Sponsors and collaborators

Lead sponsor

IRCCS Policlinico S. Donato

Other

Collaborators

  • IRCCS Casa Sollievo della Sofferenza

Registry information

Official study title

Dissecting the Complexity of Inflammatory Bowel Disease (IBD) A Prospective Study With Focus on Cardiovascular Risk

Acronym: DICOM-IBD

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Jun 23, 2026
Registry last updated
Jun 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.