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

Protocollo Sulla Valutazione Del RischiO cardioVAscolare Nel Crohn e ColIte Ulcerosa (PROVACI). Estimation of Cardiovascular Risk in Crohn's Disease and Ulcerative Colitis

Status

Enrolling by invitation

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07095634

Acronym

PROVACI

Enrollment

600

Registered

2025-07-31

Start date

2025-02-07

Completion date

2027-06-30

Last updated

2025-07-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Cardiovascular risk in IBD

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

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

16 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Occurrence of Major cardiovascular events	2 years	Myocardial infarction, stroke, transient ischemic attack, heart failure, atrial fibrillation, acute arterial embolysm, ischemic angina

Secondary

Measure	Time frame	Description
Multi-omics evaluations of biomarkers in IBD patients with occurrence of MACEs	2 years follow-up	Genomics - genetics score of investigated variants Transcritptomics - gene expression different in IBD patients with and without MACEs Microbiome - difference among IBD patients with and without MACEs Combined analysis of multi-omics data set and clinical characteristics with artificial intelligence

Countries

Italy

Outcome results