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

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

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Key information

Conditions

Ulcerative Colitis Arrhythmias, Cardiac Atrial Fibrillation Atrial Fibrillation (AF) Brain Diseases Brain Ischemia Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Colitis Colitis, Ulcerative Colonic Diseases Crohn Disease Digestive System Diseases Embolism and Thrombosis Gastroenteritis Gastrointestinal Diseases Heart Diseases Heart Failure Infarction Inflammatory Bowel Diseases Intestinal Diseases Ischemia Ischemic Attack, Transient Ischemic Heart Disease Myocardial Infarction Myocardial Ischemia Necrosis Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Stroke Thromboembolism Transient Ischemic Attack (TIA) Vascular Diseases

Age range

16 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

IRCCS San Donato POliclinic

San Donato Milanese, Milan, 20097, Italy

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Primary outcomes

Occurrence of Major cardiovascular events

Time frame: 2 years

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

Secondary outcomes

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

Time frame: 2 years follow-up

Genomics - genetics score of investigated variants Transcritptomics - gene expression different in IBD patients with and without MACEs Microbiome - difference among IBD patients with and without MACEs Combined analysis of multi-omics data set and clinical characteristics with artificial intelligence

Sponsors and collaborators

Lead sponsor

IRCCS Policlinico S. Donato

Other

Registry information

Official study title

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

Acronym: PROVACI

Important dates

Study start: 2025
Primary completion: 2026
Study completion: 2027
First posted: Jul 31, 2025
Registry last updated: Jul 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Enrolling by Invitation