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

NCT07095634 | Enrolling By Invitation

• 1 other identifier: CET 510-2024
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

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

Conditions

Ulcerative Colitis; Myocardial Infarction; Stroke; Ischemic Heart Disease; Atrial Fibrillation (AF); Thromboembolism; Crohn Disease; Transient Ischemic Attack (TIA); Heart Failure

Keywords

Cardiovascular risk in IBD

Outcome Measures

Primary Outcomes (1)

• Occurrence of Major cardiovascular events

  Myocardial infarction, stroke, transient ischemic attack, heart failure, atrial fibrillation, acute arterial embolysm, ischemic angina

  2 years

Secondary Outcomes (1)

• Multi-omics evaluations of biomarkers in IBD patients with occurrence of MACEs

  2 years follow-up

Study Arms (2)

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

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

IBD patients willing to remain in follow-up for 2 years

You may qualify if:

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

You may not qualify if:

• No willing to sign the informe content and have 2 years of follow-up

Sponsors & Collaborators

• IRCCS Policlinico S. Donato: lead

Study Sites (1)

IRCCS San Donato POliclinic

San Donato Milanese, Milan, 20097, Italy

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood sample, biopsies and stool

MeSH Terms

Conditions

Colitis, Ulcerative; Myocardial Infarction; Stroke; Myocardial Ischemia; Atrial Fibrillation; Thromboembolism; Crohn Disease; Ischemic Attack, Transient; Heart Failure

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arrhythmias, Cardiac; Embolism and Thrombosis; Brain Ischemia

Study Officials

• Vito Annese, Prof

  IRCCS Policlinico San Donato, Universita' Vita-Salute San Raffeele, Milano, Italy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor University Vita-Salute San Raffaele, Milan; Head of Gastroenterology IRCCS San Donato Policlinic

Study Record Dates

• First Submitted: July 23, 2025
• First Posted: July 31, 2025
• Study Start: February 7, 2025
• Primary Completion: February 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: July 31, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: At the end of Follow-up (End of 2028). It will be available for 5 years
• Access Criteria: Any researcher, provided that will have an approved scientific plan to gather clinical info of the study (IBD) and control cohorts

Locations

IT (1)