Estimation of Cardiovascular Risk in Patients With Crohn's Disease and Ulcerative Colitis (PROVACI)

Launched by IRCCS POLICLINICO S. DONATO · Jul 23, 2025

Keywords

ClinConnect Summary

This study, called PROVACI, is a prospective, observational project in Italy that aims to understand cardiovascular (heart and blood vessel) risk in people with inflammatory bowel diseases (Crohn’s disease or ulcerative colitis) and compare them to similar people without IBD who are already under heart care. Over about two years, researchers will track how often major heart events occur—such as heart attack, stroke, transient ischemic attack, heart failure, atrial fibrillation, arterial blockages, or ischemic chest pain—and look for factors that help predict who is at higher risk. They will also examine biological clues from blood, tissue, and stool (genetics, gene activity, and gut microbes) to see if these biomarkers relate to heart risk, using advanced data analysis.

Who can join? The study plans to enroll about 600 participants, including people aged 16 and older with Crohn’s disease or ulcerative colitis, and an age- and sex-mimicked control group without IBD who are under cardiology follow-up. Participants will have a baseline cardiovascular risk assessment and then follow-up visits over two years, with information collected and samples taken (blood, possibly tissue and stool). This is not a treatment trial and does not involve FDA-regulated drugs or devices. Enrollment is ongoing at IRCCS Policlinico San Donato in Milan, Italy, and results will be shared after follow-up ends, with data potentially available to other researchers in the future.

Gender

ALL

Eligibility 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