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

N/AEnrolling By InvitationNCT07095634

IRCCS Policlinico S. Donato600 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

600

Conditions

Ulcerative Colitis Myocardial Infarction Stroke Ischemic Heart Disease Atrial Fibrillation (AF)Thromboembolism Crohn Disease

Outcomes

Primary Outcomes

Occurrence of Major cardiovascular events

Myocardial infarction, stroke, transient ischemic attack, heart failure, atrial fibrillation, acute arterial embolysm, ischemic angina

Time frame: 2 years

Secondary Outcomes

Multi-omics evaluations of biomarkers in IBD patients with occurrence of MACEs

Genomics - genetics score of investigated variants Transcritptomics - gene expression different in IBD patients with and without MACEs Microbiome - difference among IBD patients with and without MACEs Combined analysis of multi-omics data set and clinical characteristics with artificial intelligence

Time frame: 2 years follow-up