Cardiovascular Risk in Patients With IBD (DICOM-IBD)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Cardiovascular Risk; Ulcerative Colitis (UC); Crohn's Diseases

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

• Study Contact: Name: Vito Annese, Prof. PI; Phone Number: +39 2 5277 4722; Email: vito.annese@grupposandonato.it
• Study Contact Backup: Name: Antonella Bianchi, Study Coordinator; Phone Number: 0039 02 5277 4951; Email: antonella.bianchi2@grupposandonato.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

Consecutive patients attending Gastroenterology and Cardiology Departments at IRCCS San Donato Policlinic

Description

Inclusion Criteria:

Established diagnosis of ulcerative colitis and Crohn's disease

Exclusion Criteria:

Age > 18 years Not compliant with study protocol

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Inflammatory Bowel Disease; Healthy controls

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major cardiovascular events	Stroke, myocardial infarction, atrial fibrillation, ischemic heart disease, cardiovascular death, arterial embolism	2 years

Collaborators and Investigators

• Sponsor: IRCCS Policlinico S. Donato
• Collaborators: IRCCS Casa Sollievo della Sofferenza, San Giovanni Rotondo

Publications and helpful links

General Publications

• 1.Ng, S.C.; Shi, H.Y.; Hamidi, N.; Underwood, F.E.; Tang, W.; Benchimol, E.I.; Panaccione, R.; Ghosh, S.; Wu, J.C.Y.; Chan, F.K.L.; et al. Worldwide incidence and prevalence of inflammatory bowel disease in the 21st century: A systematic review of population-based study. Lancet 2018, 390, 2769-2778. 2. Burisch, J.; Zhao, M.; Odes, S.; De Cruz, S.; Vermeire, S.; Bernstein, C.N.; Kaplan, G.G.; Duriicova, D.; Greenberg, D.; Melberg, H.O.; et al. The cost of inflammatory bowel disease in high-income settings: A Lancet Gastroenterology & Hepatology Commission. Lancet Gastroenterol. Hepatol. 2023, 8, 458-492. 3. Gros, B.; Kaplan, G.G. Ulcerative Colitis in Adults: A Review. JAMA 2023, 330, 951-965. 4. Cushing, K.; Higgins, P.D.R. Management of Crohn Disease: A Review. JAMA 2021, 325, 69-80. 5. Harbord, M.; Annese, V.; Vavricka, S.; Allez, M.; Barreiro-de Acosta, M.; Boberg, K.M.; Burisch, J.; De Vod, M.; De Vries, A.M.; Dick, A.D.; et al. The First European Evidence-based Consensus on Extra-intestinal Manifestations in Inflammatory Bowel Disease. J. Crohns Colitis 2016, 10, 239-254. 6. Jostins, L.; Ripke, S.; Weersma, R.K.; Duerr, R.H.; McGovern, D.P.; Hui, K.Y.; Lee, J.C.; Schumm, L.P.; Sharma, Y.; Anderson, C.A.; et al. Host-microbe interactions have shaped the genetic architecture of inflammatory bowel disease. Nature 2012, 491, 119-124. 7. Kumarapperuma, H.; Wang, R.; Little, P.J.; Kamato, D. Mechanistic insight: Linking cardiovascular complications of inflammatory bowel disease. Trends Cardiovasc. Med. 2024, 34, 203-211. 8. Lakhanpal, S.; Aggarwal, K.; Kaur, H.; Kanwar, K.; Gupta, V.; Bhavsar, J.; Jain, R. Cardiovascular disease: Extraintestinal manifestation of inflammatory bowel disease. Intest. Res. 2025, 23, 23-36.

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): August 1, 2029
• Study Completion (Estimated): December 1, 2029

Study Registration Dates

• First Submitted: June 17, 2026
• First Submitted That Met QC Criteria: June 17, 2026
• First Posted (Actual): June 23, 2026

Study Record Updates

• Last Update Posted (Actual): June 23, 2026
• Last Update Submitted That Met QC Criteria: June 17, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Stroke; Atrial fibrillation; Myocardial infarction; Cardiovascular risk; Crohn's disease; Ulcerative colitis; Inflammatory bowel disease; Ischemic heart disease; Cardiovascular death; Major cardiovascular events; Acute Arterial events (i.e. pulmonary embolism)
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Intestinal Diseases; Arrhythmias, Cardiac; Digestive System Diseases; Gastrointestinal Diseases; Infarction; Necrosis; Colonic Diseases; Gastroenteritis; Ischemia; Colitis; Pathological Conditions, Signs and Symptoms; Stroke; Colitis, Ulcerative; Atrial Fibrillation; Crohn Disease; Myocardial Ischemia; Inflammatory Bowel Diseases; Myocardial Infarction
• Other Study ID Numbers: CET 229-2026; RF-2024-12377843 (Other Grant/Funding Number: Research Minister)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: It shoudl be authorized by the Ethical Committee

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No