Trials / Enrolling By Invitation
Enrolling By InvitationNCT07095634
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
- Phase
- —
- Study type
- Observational
- Enrollment
- 600 (estimated)
- Sponsor
- IRCCS Policlinico S. Donato · Academic / Other
- Sex
- All
- Age
- 16 Years
- Healthy volunteers
- Accepted
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
Timeline
- Start date
- 2025-02-07
- Primary completion
- 2026-02-01
- Completion
- 2027-06-01
- First posted
- 2025-07-31
- Last updated
- 2025-07-31
Locations
1 site across 1 country: Italy
Source: ClinicalTrials.gov record NCT07095634. Inclusion in this directory is not an endorsement.