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

San Donato Group (GSD)

Status: Invitation-only

Conditions: Thromboembolism; Ischemic Heart Disease; Stroke; Atrial Fibrillation (AF); Myocardial Infarction; Heart Failure; Ulcerative Colitis; Crohn Disease; Transient Ischemic Attack (TIA)

Study type: Observational

Funder types: Other

Identifiers

NCT07095634

CET 510-2024

Details and patient eligibility

About

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

Enrollment: 600 estimated patients

Sex: All

Ages: 16+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

600 participants in 2 patient groups

IBD Patients (either with Crohn's disease or ulcerative colitis)

Description:

Baseline evaluation of CV risk score + comprehensive clinical characteristics

Control subjects without IBD

Description:

Age-and gender-matched cohort under cardiologic follow-up