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

Inflammatory bowel diseases (IBD) are progressively increasing their prevalence worldwide. Up to half of patients may also have extraintestinal manifestation and cardiovascular diseases (CVDs) is one of the most relevant, being the second cause of death in these patients. The classical cardiovascular (CV) risk scores do not adquately capture the CV risk in IBD. We are planning a prospective observational study to evaluate patients with IBD and a gender/age-matched cohort with the aims to investigate in 2-years follow-up * Occurrence of major cardiovascular events (MACEs) in both cohorts; * Predictive factors of risk for MACEs in IBD compared to controls; * Multi-omics evaluations with the support of artificial intelligence of biomarkers associated with occurrence of MACEs in IBD

NCT Number	NCT07095634
Lead Sponsor	IRCCS Policlinico S. Donato
Conditions	Ulcerative Colitis, Myocardial Infarction, Stroke, Ischemic Heart Disease, Atrial Fibrillation (AF), Thromboembolism, Crohn Disease, Transient Ischemic Attack (TIA) +1 more
Enrollment	600 participants
Start Date	2025-02-07
Primary Completion	2026-02 (estimated)
Study Completion	2027-06 (estimated)
Updated on ClinicalTrials.gov	2025-07-31