NCT07663201

Brief Summary

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
40mo left

Started Sep 2026

Typical duration for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 17, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 23, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2026

Expected
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2029

4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2029

Last Updated

June 23, 2026

Status Verified

June 1, 2026

Enrollment Period

2.9 years

First QC Date

June 17, 2026

Last Update Submit

June 17, 2026

Conditions

Ulcerative Colitis (UC)Crohn's DiseasesCardiovascular Risk

Keywords

Ulcerative colitisCrohn's diseaseInflammatory bowel diseaseCardiovascular riskStrokeCardiovascular deathMyocardial infarctionAtrial fibrillationIschemic heart diseaseMajor cardiovascular eventsAcute Arterial events (i.e. pulmonary embolism)

Outcome Measures

Primary Outcomes (1)

  • Major cardiovascular events

    Stroke, myocardial infarction, atrial fibrillation, ischemic heart disease, cardiovascular death, arterial embolism

    2 years

Study Arms (1)

Inflammatory Bowel Disease

Healthy controls

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Consecutive patients attending Gastroenterology and Cardiology Departments at IRCCS San Donato Policlinic

You may qualify if:

  • Established diagnosis of ulcerative colitis and Crohn's disease

You may not qualify if:

  • Age \> 18 years Not compliant with study protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Blood, stool, mucosal biopsies

MeSH Terms

Conditions

Colitis, UlcerativeCrohn DiseaseInflammatory Bowel DiseasesStrokeMyocardial InfarctionAtrial FibrillationMyocardial Ischemia

Condition Hierarchy (Ancestors)

ColitisGastroenteritisGastrointestinal DiseasesDigestive System DiseasesColonic DiseasesIntestinal DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesHeart DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisArrhythmias, Cardiac

Central Study Contacts

Vito Annese, Prof. PI

CONTACT

+39 2 5277 4722vito.annese@grupposandonato.it

Antonella Bianchi, Study Coordinator

CONTACT

0039 02 5277 4951antonella.bianchi2@grupposandonato.it

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 17, 2026

First Posted

June 23, 2026

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

August 1, 2029

Study Completion (Estimated)

December 1, 2029

Last Updated

June 23, 2026

Record last verified: 2026-06