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

Status: Recruiting
Location: See location...
Study Type: Observational
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 16
Healthy Volunteers: t
View:

• Patients with confrimed diagnosis of Crohn's disease and Ulcerative colitis-

Locations
Other Locations
Italy
IRCCS San Donato POliclinic
RECRUITING
San Donato Milanese
Contact Information
Primary
Vito Annese, Prof.
vito.annese@grupposandonato.it
+39 3388261812
Backup
Orsola Raffaella R Sociale, Ns. Study coordinator
orsolaraffaella.sociale@grupposandonato.it
+39 2 5277 4951
Time Frame
Start Date: 2025-02-07
Estimated Completion Date: 2027-06
Participants
Target number of participants: 600
Treatments
IBD Patients (either with Crohn's disease or ulcerative colitis)
Baseline evaluation of CV risk score + comprehensive clinical characteristics
Control subjects without IBD
Age-and gender-matched cohort under cardiologic follow-up
Sponsors
Leads: IRCCS Policlinico S. Donato

This content was sourced from clinicaltrials.gov