Estimation of Cardiovascular Risk in Patients With Crohn's Disease and Ulcerative Colitis (PROVACI)
NCT07095634 · Status: ENROLLING_BY_INVITATION · Type: OBSERVATIONAL · Enrollment: 600
Last updated 2025-07-31
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
Conditions
- Ulcerative Colitis
- Myocardial Infarction
- Stroke
- Ischemic Heart Disease
- Atrial Fibrillation (AF)
- Thromboembolism
- Crohn Disease
- Transient Ischemic Attack (TIA)
- Heart Failure
Sponsors & Collaborators
-
IRCCS Policlinico S. Donato
lead OTHER
Principal Investigators
-
Vito Annese, Prof · IRCCS Policlinico San Donato, Universita' Vita-Salute San Raffeele, Milano, Italy
Eligibility
- Min Age
- 16 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2025-02-07
- Primary Completion
- 2026-02-28
- Completion
- 2027-06-30
Countries
- Italy
Study Locations
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