Ulcerative ColitisPROVACINCT07095634
Estimation of Cardiovascular Risk in Patients With Crohn's Disease and Ulcerative Colitis (PROVACI)
An observational study of Ulcerative Colitis and Myocardial Infarction, run by IRCCS Policlinico S. Donato at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ulcerative Colitis, Myocardial Infarction, Stroke
- How many people
- 600 participants
- Where
- 1 siteItaly
- Study dates
- 7 Feb 2025to Jun 2027
- How long will I take part?
- 2 Years
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: IBD patients willing to remain in follow-up for 2 years
Who may be able to join
- Patients with confrimed diagnosis of Crohn's disease and Ulcerative colitis-
Who cannot join
- No willing to sign the informe content and have 2 years of follow-up
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Orsola Raffaella R Sociale, Ns. Study coordinator contact
Italy1 site, 1 recruiting
- Recruiting
IRCCS San Donato POliclinic
San Donato Milanese, Milan, 20097
About this study
Official title: Protocollo Sulla Valutazione Del RischiO cardioVAscolare Nel Crohn e ColIte Ulcerosa (PROVACI). Estimation of Cardiovascular Risk in Crohn's Disease and Ulcerative Colitis
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
- Keywords
- Cardiovascular risk in IBD
- Medical subject headings
- Colitis, Ulcerative, Myocardial Infarction, Stroke, Myocardial Ischemia, Atrial Fibrillation, Thromboembolism, Crohn Disease, Ischemic Attack, Transient
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of Major cardiovascular events
The number of each and every cardiovacular event such as myocardial infarction, stroke, transient ischemic attack, heart failure, atrial fibrillation, acute arterial embolysm, ischemic angina will be recorded.
Measured: 2 years
Secondary outcomes (1)
Multi-omics evaluations of biomarkers in IBD patients with occurrence of MACEs
Genomics - genetics log score score of investigated variants in patients without and without MACES Transcritptomics - difference of mucosal gene expression in IBD patients with and without MACEs Microbiome - difference of among IBD patients with and without MACEs in terms of alpha diversity and dysbiosis index Combined analysis of all multi-omics data set and clinical characteristics with artificial intelligence once again comparing +patients with and without occurrence of MACEs during the follow-up to identify predisposing makers
Measured: 2 years follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2025
- Study start7 Feb 2025
- Primary completionFeb 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- IRCCS Policlinico S. Donato
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vito Annese, IRCCS Policlinico S. Donato
- Investigators
- Vito Annese, Prof, Principal investigator, IRCCS Policlinico San Donato, Universita' Vita-Salute San Raffeele, Milano, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07095634
- Sponsor's protocol ID
- CET 510-2024
- Acronym
- PROVACI
- Status last verified
- Oct 2026
- First submitted
- 23 Jul 2025
- Last updated
- 16 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Characteristics of Study and control cohorts