Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of Major cardiovascular events | Myocardial infarction, stroke, transient ischemic attack, heart failure, atrial fibrillation, acute arterial embolysm, ischemic angina | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Multi-omics evaluations of biomarkers in IBD patients with occurrence of MACEs | 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 | 2 years follow-up |
Not provided
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
Not provided
Not provided
Not provided
IBD patients willing to remain in follow-up for 2 years
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Vito Annese, Prof | IRCCS Policlinico San Donato, Universita' Vita-Salute San Raffeele, Milano, Italy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS San Donato POliclinic | San Donato Milanese | Milan | 20097 | Italy |
Characteristics of Study and control cohorts
At the end of Follow-up (End of 2028). It will be available for 5 years
Any researcher, provided that will have an approved scientific plan to gather clinical info of the study (IBD) and control cohorts
Not provided
Not provided
Not provided
Not provided
Blood sample, biopsies and stool
| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| D009203 | Myocardial Infarction |
| D020521 | Stroke |
| D017202 | Myocardial Ischemia |
| D001281 | Atrial Fibrillation |
| D013923 | Thromboembolism |
| D003424 | Crohn Disease |
| D002546 | Ischemic Attack, Transient |
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D015212 | Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D001145 | Arrhythmias, Cardiac |
| D016769 | Embolism and Thrombosis |
| D002545 | Brain Ischemia |
Not provided
Not provided