Cardiovascular risk in people with Crohn's disease and ulcerative colitis
Official title: Protocollo Sulla Valutazione Del RischiO cardioVAscolare Nel Crohn e ColIte Ulcerosa (PROVACI). Estimation of Cardiovascular Risk in Crohn's Disease and Ulcerative Colitis
Run by IRCCS Policlinico S. Donato · NCT07095634 · Data updated 2026-11-12
This study tests whether people with inflammatory bowel disease have different heart-attack or stroke risk over two years compared with matched controls.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 16 Years and up |
| Sex | All |
| Enrollment | 600 (estimated) |
| Sponsor | IRCCS Policlinico S. Donato Academic / other |
| Locations | 1 site (San Donato Milanese, Milan) |
| Status | Recruiting |
| Started | February 7, 2025 |
| Main results expected | February 2027 |
| Study ends | June 2027 |
| Registry record updated | October 16, 2026 |
| Trial ID | NCT07095634 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with confirmed Crohn's disease or ulcerative colitis who can commit to 2 years of follow-up.
✕Probably not a fit
Patients unlikely to benefit are those without a long enough life expectancy or who cannot complete the 2-year follow-up.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective observational study that follows adults with Crohn's disease or ulcerative colitis and a matched control group for two years to compare the occurrence of major cardiovascular events. The researchers will examine factors that predict MACEs in IBD versus controls and will apply multi-omics analyses with artificial intelligence to identify biomarkers linked to cardiovascular risk in IBD. The aim is to improve understanding of how IBD relates to cardiovascular outcomes and to identify potential predictors beyond traditional risk scores. No intervention is being tested; the study observes real-world patient outcomes. Enrollment is at IRCCS Policlinico San Donato in Milan, Italy, with participants required to have a confirmed IBD diagnosis and to commit to 2 years of follow-up.
Why it matters
Potential benefit: Findings could improve how cardiovascular risk is assessed and managed in people with IBD.
How similar studies have gone: Previous work suggests cardiovascular risk is higher in IBD, but this study adds prospective data and multi-omics approaches for biomarker discovery.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: Patients with confrimed diagnosis of Crohn's disease and Ulcerative colitis- Exclusion Criteria: No willing to sign the informe content and have 2 years of follow-up
Where it's running
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IRCCS San Donato POliclinic
San Donato Milanese, Milan, Italy Recruiting
Study contacts
- Principal investigator: Vito Annese, Prof — IRCCS Policlinico San Donato, Universita' Vita-Salute San Raffeele, Milano, Italy
- Study coordinator: Vito Annese, Prof.
- Email: vito.annese@grupposandonato.it
- Phone: +39 3388261812
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.