Ignite Creation Date:
2025-12-25 @ 2:31 AM
Ignite Modification Date:
2025-12-31 @ 12:20 PM
Study NCT ID:
NCT07095634
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-07-31
First Post:
2025-07-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Estimation of Cardiovascular Risk in Patients With Crohn's Disease and Ulcerative Colitis (PROVACI)
Sponsor:
IRCCS Policlinico S. Donato
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PROVACI
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: