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| ID | Type | Description | Link |
|---|---|---|---|
| RF-2024-12377843 | Other Grant/Funding Number | Research Minister |
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| Name | Class |
|---|---|
| IRCCS Casa Sollievo della Sofferenza, San Giovanni Rotondo | UNKNOWN |
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In this study our Research Hospital San Donato Policlinic ask your partipation with the aim to evaluate the risk of cardiovascular complication (i.e. stroke, myocardial infarction) in patients with inflammatory bowel disease. Multiple parameters (therapy, disease activity, life style) and investigations (DNA, stool, lab tests) will be evaluate with the support of artificial intelligence methodologies to better define the cardiovascular risk.
Emerging evidence points to shared pathophysiological mechanisms between IBD and Cardiovascular disease (CVD), including genetic overlap (e.g., NOD2, CDKN2B, stromelysin, and ApoE polymorphisms), shared environmental triggers like smoking, and convergent immune pathways Disruption of both intestinal epithelial and vascular endothelial barriers through cytokines like TNF-a may provide a mechanistic link between gut inflammation and vascular pathology. In addition, gut microbiota alterations commonly seen in IBD have been implicated in the pathogenesis of cardiovascular conditions such as atherosclerosis.
There is still an unmet need to evaluate the real amount of CV risk in patients with IBD because of the lack of prospective trials, and the limitation of the available CV risk scores designed for an older background population compared to the patients with IBD. In addition, there is a lack of a systematic and combined evaluation of other possible shared risk factors, such as genetic polymorphisms or dysbiosis, and more importantly, the need to evaluate the full systematic dataset prospectively and with a hypothesis-free powerful methodology, such as artificial intelligence (AI)-driven algorithms.
Our first objective is to prospectively evaluate the occurrence of MACEs in a large cohort (±300) of IBD patients enrolled within the Unit of Gastroenterology of the IRCCS San Donato Policlinic, San Donato Milanese (Mi), and followed for 2 years. The occurrence of MACEs will be compared as a whole or individually with those of an age/gender-matched cohort under follow-up at the Unit of Cardiology of the same Institution in the CV PREVITAL study (NCT053399841). The occurrence of the MACEs in IBD patients will be evaluated by the PI and collaborators during the periodic control visit that will occurred at least after one and 2 years since the enrolling in this study, but that usually occur also more frequently (every 3-6 months) according to the underlying condition of IBD.
The secondary objectives will be to correlate the clinical characteristics of IBD patients (disease activity, therapy, etc.) and to undertake an extensive multi-omics, metabolic, and histological evaluation to identify additional risk factors which might increase the occurrence of MACES as compared to control population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Inflammatory Bowel Disease | Healthy controls |
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| Measure | Description | Time Frame |
|---|---|---|
| Major cardiovascular events | Stroke, myocardial infarction, atrial fibrillation, ischemic heart disease, cardiovascular death, arterial embolism | 2 years |
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Inclusion Criteria:
Established diagnosis of ulcerative colitis and Crohn's disease
Exclusion Criteria:
Age > 18 years Not compliant with study protocol
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Consecutive patients attending Gastroenterology and Cardiology Departments at IRCCS San Donato Policlinic
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Vito Annese, Prof. PI | Contact | +39 2 5277 4722 | vito.annese@grupposandonato.it | |
| Antonella Bianchi, Study Coordinator | Contact | 0039 02 5277 4951 | antonella.bianchi2@grupposandonato.it |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 1.Ng, S.C.; Shi, H.Y.; Hamidi, N.; Underwood, F.E.; Tang, W.; Benchimol, E.I.; Panaccione, R.; Ghosh, S.; Wu, J.C.Y.; Chan, F.K.L.; et al. Worldwide incidence and prevalence of inflammatory bowel disease in the 21st century: A systematic review of population-based study. Lancet 2018, 390, 2769-2778. 2. Burisch, J.; Zhao, M.; Odes, S.; De Cruz, S.; Vermeire, S.; Bernstein, C.N.; Kaplan, G.G.; Duriicova, D.; Greenberg, D.; Melberg, H.O.; et al. The cost of inflammatory bowel disease in high-income settings: A Lancet Gastroenterology & Hepatology Commission. Lancet Gastroenterol. Hepatol. 2023, 8, 458-492. 3. Gros, B.; Kaplan, G.G. Ulcerative Colitis in Adults: A Review. JAMA 2023, 330, 951-965. 4. Cushing, K.; Higgins, P.D.R. Management of Crohn Disease: A Review. JAMA 2021, 325, 69-80. 5. Harbord, M.; Annese, V.; Vavricka, S.; Allez, M.; Barreiro-de Acosta, M.; Boberg, K.M.; Burisch, J.; De Vod, M.; De Vries, A.M.; Dick, A.D.; et al. The First European Evidence-based Consensus on Extra-intestinal Manifestations in Inflammatory Bowel Disease. J. Crohns Colitis 2016, 10, 239-254. 6. Jostins, L.; Ripke, S.; Weersma, R.K.; Duerr, R.H.; McGovern, D.P.; Hui, K.Y.; Lee, J.C.; Schumm, L.P.; Sharma, Y.; Anderson, C.A.; et al. Host-microbe interactions have shaped the genetic architecture of inflammatory bowel disease. Nature 2012, 491, 119-124. 7. Kumarapperuma, H.; Wang, R.; Little, P.J.; Kamato, D. Mechanistic insight: Linking cardiovascular complications of inflammatory bowel disease. Trends Cardiovasc. Med. 2024, 34, 203-211. 8. Lakhanpal, S.; Aggarwal, K.; Kaur, H.; Kanwar, K.; Gupta, V.; Bhavsar, J.; Jain, R. Cardiovascular disease: Extraintestinal manifestation of inflammatory bowel disease. Intest. Res. 2025, 23, 23-36. |
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It shoudl be authorized by the Ethical Committee
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| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| D003424 | Crohn Disease |
| D015212 | Inflammatory Bowel Diseases |
| D020521 | Stroke |
| D009203 | Myocardial Infarction |
| D001281 | Atrial Fibrillation |
| D017202 | Myocardial Ischemia |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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Blood, stool, mucosal biopsies
| D003108 |
| Colonic Diseases |
| D007410 | Intestinal Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D001145 | Arrhythmias, Cardiac |