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

Sponsor
IRCCS Policlinico S. Donato
Study ID
NCT07095634
Status
Enrolling By Invitation

Conditions

Eligibility Criteria

Sex
ALL
Age
16 Years - N/A
Healthy Volunteers
Accepted

Study Details

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

Key Dates

First listed
Jul 31, 2025
Start date
Feb 7, 2025
Status verified
Jul 2025
Primary completion
Feb 28, 2026
Completion
Jun 30, 2027

Study Design

Enrollment
600 participants (estimated)

Arms

  • Arm: IBD Patients (either with Crohn's disease or ulcerative colitis)
    Baseline evaluation of CV risk score + comprehensive clinical characteristics
  • Arm: Control subjects without IBD
    Age-and gender-matched cohort under cardiologic follow-up

Primary Outcome Measure

Occurrence of Major cardiovascular events [ Time Frame: 2 years ]

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