Estimation of Cardiovascular Risk in Patients With Crohn's Disease and Ulcerative Colitis (PROVACI)
Observational · No treatment assigned · 1 site · IRCCS Policlinico S. Donato
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
Condition(s) listed: Ulcerative Colitis, Myocardial Infarction and Stroke. This is an observational study: researchers collect information (for example questionnaires, samples, or scans) but the study does not assign a treatment.
Who can join
- Ages 16 and older
- Any sex
- Healthy volunteers accepted
Some of the main requirements, copied from the record:
- Patients with confrimed diagnosis of Crohn's disease and Ulcerative colitis-
There are also 1 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 600 participants are expected to take part.
- The study has 2 groups.
- Start date: 2025-02-07.
- Main results expected around 2027-02 (estimate from the record).
- 1 study site listed (1 marked recruiting) in Italy.
Groups in this study
- IBD Patients (either with Crohn's disease or ulcerative colitis)
- Control subjects without IBD
Main thing being measured
- Occurrence of Major cardiovascular events (2 years)
In the researchers’ words
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.
This summary was written automatically from the official record using fixed templates (no AI), so it only says what the record says, and may leave things out.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Observational |
| Study type | Observational |
| Conditions | Ulcerative Colitis; Myocardial Infarction; Stroke; Ischemic Heart Disease; Atrial Fibrillation (AF); Thromboembolism; Crohn Disease; Transient Ischemic Attack (TIA); Heart Failure |
| Lead sponsor | IRCCS Policlinico S. Donato |
| Enrollment | 600 (estimated) |
| Start date | 2025-02-07 |
| Primary completion (est.) | 2027-02 |
| First posted | 2025-07-31 |
| Last updated | 2026-10-16 |
| 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 |
| ClinicalTrials.gov ID | NCT07095634 |
Interventions
- None listed
Full eligibility criteria (from the record)
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
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| IRCCS San Donato POliclinic | San Donato Milanese, Milan | Italy | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.