Ignite Creation Date:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2025-12-26 @ 3:00 AM
Study NCT ID:
NCT05735002
Status:
RECRUITING
Last Update Posted:
2025-07-04
First Post:
2023-02-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Promoting Early Diagnosis of Chronic Mesenteric Ischemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood samples will be collected to search for specific biomarkers for chronic mesenteric ischemia'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 296}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2027-04-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-01', 'studyFirstSubmitDate': '2023-02-09', 'studyFirstSubmitQcDate': '2023-02-09', 'lastUpdatePostDateStruct': {'date': '2025-07-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Breath test', 'timeFrame': '2023-2025', 'description': '\\- To validate the butyrate breath test as a specific functional test with a high positive predictive value to rightfully diagnose and select patients who will benefit from invasive treatment.'}, {'measure': 'calcium scores', 'timeFrame': '2023-2035', 'description': 'To validate the mesenteric artery calcium score as a readily available, easy, and sensitive test with a high negative predictive value to either rule out CMI or select patients for further investigations.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['breath test, chronic mesenteric ischemie, calcium scoring'], 'conditions': ['Chronic Mesenteric Ischemia']}, 'descriptionModule': {'briefSummary': "CMI is an incapacitating disease and timely diagnosis remains problematic. Despite the substantial compensatory capacity of the mesenteric circulation CMI is relatively common, its incidence being comparable to other well-known diseases like Crohn's disease.\n\nDiagnostic tools are needed for two purposes since the exclusion of CMI currently requires a cumbersome complication-prone diagnostic workup and since a definitive diagnosis is mainly established per exclusionem. First, a sensitive test is desirable to rule out CMI and avoid excessive diagnostic investigations. Quantification of mesenteric arterial calcification on computed tomography (CT) seems suitable for this purpose, synonymous with the coronary artery calcium score. Second, a specific test is required confirming CMI by detection of mucosal ischemia during a meal, when oxygen demand peaks. A breath test, based on the requirement of oxygen to absorb and metabolize 13C-butyrate in the enterocyte, could detect mucosal ischemia\n\nObjective: Facilitating diagnosis of chronic mesenteric ischemia (CMI) using 1) the mesenteric artery calcium score (MACS) and 2) mucosal ischemia detection by butyrate breath testing\n\nStudy design: Multicentre prospective cohort studies."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All patients with suspected CMI', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with a clinical suspicion of CMI referred to Maagdarm Ischemie Centrum Rotterdam (MICR), MST or UMCG.\n* Patients ≥ 18 years\n\nExclusion Criteria:\n\n* Patients who are unable to give informed consent\n* Patients with previous mesenteric artery revascularization\n* No available CT imaging and contraindications for CT imaging (e.g. pregnancy)\n* Common origin of the celiac artery and superior mesenteric artery\n* Known delayed gastric emptying\n* Known and untreated small intestinal bacterial overgrowth'}, 'identificationModule': {'nctId': 'NCT05735002', 'acronym': 'PROMISE', 'briefTitle': 'Promoting Early Diagnosis of Chronic Mesenteric Ischemia', 'organization': {'class': 'OTHER', 'fullName': 'Erasmus Medical Center'}, 'officialTitle': 'PRomoting Early Diagnosis Of Chronic Mesenteric ISchEmia by a Mesenteric Artery Calcium Score Based Risk Stratification and Detection of Postprandial Mucosal Ischemia by Butyrate Breath Testing', 'orgStudyIdInfo': {'id': '9933'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with suspected CMI', 'description': 'Patients with suspected CMI', 'interventionNames': ['Diagnostic Test: 13C-butyrate breath test']}], 'interventions': [{'name': '13C-butyrate breath test', 'type': 'DIAGNOSTIC_TEST', 'description': 'breath test', 'armGroupLabels': ['Patients with suspected CMI']}]}, 'contactsLocationsModule': {'locations': [{'zip': '7512KZ', 'city': 'Enschede', 'state': 'Overijssel', 'status': 'NOT_YET_RECRUITING', 'country': 'Netherlands', 'facility': 'Medisch Spectrum Twente', 'geoPoint': {'lat': 52.21833, 'lon': 6.89583}}, {'zip': '9713GZ', 'city': 'Groningen', 'state': 'Provincie Groningen', 'status': 'NOT_YET_RECRUITING', 'country': 'Netherlands', 'facility': 'University Medical Centre Groningen', 'geoPoint': {'lat': 53.21917, 'lon': 6.56667}}, {'zip': '3015GD', 'city': 'Rotterdam', 'state': 'South Holland', 'status': 'RECRUITING', 'country': 'Netherlands', 'facility': 'Erasmus University Medical Centre Rotterdam', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}, {'zip': '3045PM', 'city': 'Rotterdam', 'state': 'South Holland', 'status': 'RECRUITING', 'country': 'Netherlands', 'facility': 'Franciscus', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}], 'centralContacts': [{'name': 'Eva Karina Bocharewicz, MD, PhD Candidate', 'role': 'CONTACT', 'email': 'e.bocharewicz@erasmusmc.nl', 'phone': '0031652216196'}, {'name': 'Desirée Leemreis - van Noord, MD, PhD', 'role': 'CONTACT', 'email': 'd.leemreis-vannoord@erasmusmc.nl'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Erasmus Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Maag Lever Darm Stichting', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Gastroenterologist', 'investigatorFullName': 'Marco J. Bruno', 'investigatorAffiliation': 'Erasmus Medical Center'}}}}