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NCT07095634
Estimation of Cardiovascular Risk in Patients With Crohn's Disease and Ulcerative Colitis (PROVACI)
Conditions: Ulcerative Colitis, Myocardial Infarction, Stroke, Ischemic Heart Disease, Atrial Fibrillation (AF), Thromboembolism, Crohn Disease, Transient Ischemic Attack (TIA), Heart Failure
Sex: All
Ages: 16 Years – N/A
Healthy volunteers: Yes
Enrollment: 600
Sponsor: IRCCS Policlinico S. Donato
Location: IRCCS San Donato POliclinic San Donato Milanese Milan
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
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
Source: ClinicalTrials.gov (NCT07095634). StuddyBuddy aggregates publicly available trial information.