Life sciences · Observational Study
ClinicalTrials.gov · October 16, 2026
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Observational Study.
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Registry record from ClinicalTrials.gov (NCT07095634). This is a study registration, not published results. Lead sponsor: IRCCS Policlinico S. Donato. Recruitment status: RECRUITING. Study type: OBSERVATIONAL. Enrollment: 600 participants (ESTIMATED). Conditions: Ulcerative Colitis, Myocardial Infarction, Stroke, Ischemic Heart Disease, Atrial Fibrillation (AF), Thromboembolism, Crohn Disease, Transient Ischemic Attack (TIA), Heart Failure. Primary outcome measures: Occurrence of Major cardiovascular events , 2 years. Brief summary: 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