Ulcerative Colitis (UC)DICOM-IBDNCT07663201
Cardiovascular Risk in Patients With IBD
An observational study of Ulcerative Colitis (UC) and Crohn's Diseases, run by IRCCS Policlinico S. Donato.
Trial summary
In this study the Research Hospital San Donato Policlinic ask the participation with the aim to evaluate the risk of cardiovascular complication (i.e. stroke, myocardial infarction) in patients with inflammatory bowel disease. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ulcerative Colitis (UC), Crohn's Diseases, Cardiovascular Risk
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- Sep 2026to Dec 2029
- Phase
- Observational
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: Consecutive patients attending Gastroenterology and Cardiology Departments at IRCCS San Donato Policlinic
Who may be able to join
- Established diagnosis of ulcerative colitis and Crohn's disease
Who cannot join
- Age > 18 years Not compliant with study protocol
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Dissecting the Complexity of Inflammatory Bowel Disease (IBD) A Prospective Study With Focus on Cardiovascular Risk
In this study the Research Hospital San Donato Policlinic ask the participation 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.
Read the 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.
The 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.
- Keywords
- Ulcerative colitis, Crohn's disease, Inflammatory bowel disease, Cardiovascular risk, Stroke, Cardiovascular death, Myocardial infarction, Atrial fibrillation, Ischemic heart disease, Major cardiovascular events, Acute Arterial events (i.e. pulmonary embolism)
- Medical subject headings
- Colitis, Ulcerative, Crohn Disease, Inflammatory Bowel Diseases, Stroke, Myocardial Infarction, Atrial Fibrillation, Myocardial Ischemia
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 |
|---|---|---|
| Inflammatory Bowel Disease | Healthy controls |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major cardiovascular events
Stroke, myocardial infarction, atrial fibrillation, ischemic heart disease, cardiovascular death, arterial embolism
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2026
- Study startSep 2026 (estimated)
- Primary completionAug 2029 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ulcerative Colitis (UC)Studies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS Policlinico S. Donato
- Sponsor type
- University, hospital or other
- Collaborators
- IRCCS Casa Sollievo della Sofferenza
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07663201
- Sponsor's protocol ID
- CET 229-2026
- Other IDs
- RF-2024-12377843
- Acronym
- DICOM-IBD
- Status last verified
- Jun 2026
- First submitted
- 17 Jun 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: It shoudl be authorized by the Ethical Committee
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.