An observational study in Ulcerative Colitis, Myocardial Infarction and Stroke, sponsored by IRCCS Policlinico S. Donato. Recruiting at 1 site in Italy. Open to participants aged 16 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-16.
Sponsored by IRCCS Policlinico S. Donato · Observational
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
1,853 studies on the registry are indexed under Colitis, Ulcerative; 472 are open to participants now.
This study's planned enrollment of 600 is above the median of 198 across 551 observational studies indexed under Colitis, Ulcerative.
Browse Colitis, Ulcerative studies →IRCCS Policlinico S. Donato is the lead sponsor of 103 studies on the registry; 51 are open to participants now.
Counted across the registry records on this site, refreshed daily.
IBD patients willing to remain in follow-up for 2 years
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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
Baseline evaluation of CV risk score + comprehensive clinical characteristics
Age-and gender-matched cohort under cardiologic follow-up
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.
Time frame: 2 years
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
Time frame: 2 years follow-up
Plan to share: Yes — Characteristics of Study and control cohorts
Supporting information: Study protocol, Informed consent form, Clinical study report
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
Data sharing details ↗ · www.google.com
No publications or documents are linked to this record.
Started Feb 2025 (actual). Primary completion is estimated for Feb 2027, 24 months after the start.
Of 188 non-industry observational studies under Colitis, Ulcerative, half reached primary completion within 51 months of starting (the median), counting those still running; a quarter within 30 and three quarters within 119. This study's planned 24 months is below that.
Counting every sponsor, half of 271 studies reached it within 47 months; a quarter within 29 and three quarters within 90.
Primary completion moved once since we started tracking on Sep 25, 2026: Feb 2026 → Feb 2027, on Oct 16, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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