Estimation of Cardiovascular Risk in Patients With Crohn's Disease and Ulcerative Colitis (PROVACI)
NCT ID: NCT07095634
Last Updated: 2025-07-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
600 participants
OBSERVATIONAL
2025-02-07
2027-06-30
Brief Summary
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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
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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IBD Patients (either with Crohn's disease or ulcerative colitis)
Baseline evaluation of CV risk score + comprehensive clinical characteristics
No interventions assigned to this group
Control subjects without IBD
Age-and gender-matched cohort under cardiologic follow-up
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
16 Years
ALL
Yes
Sponsors
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IRCCS Policlinico S. Donato
OTHER
Responsible Party
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Vito Annese
Associate Professor University Vita-Salute San Raffaele, Milan; Head of Gastroenterology IRCCS San Donato Policlinic
Principal Investigators
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Vito Annese, Prof
Role: PRINCIPAL_INVESTIGATOR
IRCCS Policlinico San Donato, Universita' Vita-Salute San Raffeele, Milano, Italy
Locations
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IRCCS San Donato POliclinic
San Donato Milanese, Milan, Italy
Countries
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Other Identifiers
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CET 510-2024
Identifier Type: -
Identifier Source: org_study_id
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