Ignite Creation Date:
2025-12-25 @ 2:31 AM
Ignite Modification Date:
2026-02-20 @ 1:45 PM
Study NCT ID:
NCT07095634
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-07-31
First Post:
2025-07-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Estimation of Cardiovascular Risk in Patients With Crohn's Disease and Ulcerative Colitis (PROVACI)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003093', 'term': 'Colitis, Ulcerative'}, {'id': 'D009203', 'term': 'Myocardial Infarction'}, {'id': 'D020521', 'term': 'Stroke'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D001281', 'term': 'Atrial Fibrillation'}, {'id': 'D013923', 'term': 'Thromboembolism'}, {'id': 'D003424', 'term': 'Crohn Disease'}, {'id': 'D002546', 'term': 'Ischemic Attack, Transient'}, {'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D003092', 'term': 'Colitis'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009336', 'term': 'Necrosis'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D002545', 'term': 'Brain Ischemia'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood sample, biopsies and stool'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 600}, 'targetDuration': '2 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2025-02-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2027-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-23', 'studyFirstSubmitDate': '2025-07-23', 'studyFirstSubmitQcDate': '2025-07-23', 'lastUpdatePostDateStruct': {'date': '2025-07-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Occurrence of Major cardiovascular events', 'timeFrame': '2 years', 'description': 'Myocardial infarction, stroke, transient ischemic attack, heart failure, atrial fibrillation, acute arterial embolysm, ischemic angina'}], 'secondaryOutcomes': [{'measure': 'Multi-omics evaluations of biomarkers in IBD patients with occurrence of MACEs', 'timeFrame': '2 years follow-up', 'description': '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'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cardiovascular risk in IBD'], 'conditions': ['Ulcerative Colitis', 'Myocardial Infarction', 'Stroke', 'Ischemic Heart Disease', 'Atrial Fibrillation (AF)', 'Thromboembolism', 'Crohn Disease', 'Transient Ischemic Attack (TIA)', 'Heart Failure']}, 'descriptionModule': {'briefSummary': '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.\n\nWe 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\n\n* Occurrence of major cardiovascular events (MACEs) in both cohorts;\n* Predictive factors of risk for MACEs in IBD compared to controls;\n* Multi-omics evaluations with the support of artificial intelligence of biomarkers associated with occurrence of MACEs in IBD'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'IBD patients willing to remain in follow-up for 2 years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\nPatients with confrimed diagnosis of Crohn's disease and Ulcerative colitis-\n\nExclusion Criteria:\n\nNo willing to sign the informe content and have 2 years of follow-up"}, 'identificationModule': {'nctId': 'NCT07095634', 'acronym': 'PROVACI', 'briefTitle': "Estimation of Cardiovascular Risk in Patients With Crohn's Disease and Ulcerative Colitis (PROVACI)", 'organization': {'class': 'OTHER', 'fullName': 'IRCCS Policlinico S. Donato'}, 'officialTitle': "Protocollo Sulla Valutazione Del RischiO cardioVAscolare Nel Crohn e ColIte Ulcerosa (PROVACI). Estimation of Cardiovascular Risk in Crohn's Disease and Ulcerative Colitis", 'orgStudyIdInfo': {'id': 'CET 510-2024'}}, 'armsInterventionsModule': {'armGroups': [{'label': "IBD Patients (either with Crohn's disease or ulcerative colitis)", 'description': 'Baseline evaluation of CV risk score + comprehensive clinical characteristics'}, {'label': 'Control subjects without IBD', 'description': 'Age-and gender-matched cohort under cardiologic follow-up'}]}, 'contactsLocationsModule': {'locations': [{'zip': '20097', 'city': 'San Donato Milanese', 'state': 'Milan', 'country': 'Italy', 'facility': 'IRCCS San Donato POliclinic', 'geoPoint': {'lat': 45.41047, 'lon': 9.26838}}], 'overallOfficials': [{'name': 'Vito Annese, Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "IRCCS Policlinico San Donato, Universita' Vita-Salute San Raffeele, Milano, Italy"}]}, 'ipdSharingStatementModule': {'url': 'https://www.google.com/url?sa=t&source=web&rct=j&opi=89978449&url=https://www.grupposandonato.it/strutture/policlinico-san-donato/contatti&ved=2ahUKEwi5sIL2_9KOAxXCiP0HHfV1JHAQFnoECBwQAQ&usg=AOvVaw2nNbGXySjQHZH9GVwkP1sN', 'infoTypes': ['STUDY_PROTOCOL', 'ICF', 'CSR'], 'timeFrame': 'At the end of Follow-up (End of 2028). It will be available for 5 years', 'ipdSharing': 'YES', 'description': 'Characteristics of Study and control cohorts', 'accessCriteria': 'Any researcher, provided that will have an approved scientific plan to gather clinical info of the study (IBD) and control cohorts'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'IRCCS Policlinico S. Donato', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor University Vita-Salute San Raffaele, Milan; Head of Gastroenterology IRCCS San Donato Policlinic', 'investigatorFullName': 'Vito Annese', 'investigatorAffiliation': 'IRCCS Policlinico S. Donato'}}}}