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

Study acronym: PROVACI
StatusRecruiting
PhaseNot specified
Started

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Trial flagged as At Risk
Primary completion moved at least 11 months later Feb 2026 → Feb 2027
See other at-risk trials from IRCCS Policlinico S. Donato

Record History

  1. Primary completion pushed from Feb 2026 to Feb 2027
    • Trial status changed: Enrolling by Invitation → Recruiting
    • Secondary endpoints: details revised at 1 of 1 entry
    • Site details revised
  2. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
IRCCS Policlinico S. Donato
51 trials monitored
See 3 trials at risk
Heart Disease
8,814 trials monitored
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Stroke
3,537 trials monitored
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Heart Failure
2,000 trials monitored
See 115 trials at risk
and 3 more diseases
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
Trial Details
NCT Number NCT07095634
Lead Sponsor IRCCS Policlinico S. Donato
Conditions
(from sponsor)		 Ulcerative Colitis, Myocardial Infarction, Stroke, Ischemic Heart Disease, Atrial Fibrillation (AF), Thromboembolism, Crohn Disease, Transient Ischemic Attack (TIA) +1 more
Related terms Atrial Fibrillation, Colitis, Ulcerative, Crohn Disease, Heart Failure, Ischemic Attack, Transient, Myocardial Infarction, Myocardial Ischemia, Stroke, Thromboembolism
Enrollment 600 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov