Ignite Creation Date:
2025-12-25 @ 3:27 AM
Ignite Modification Date:
2025-12-26 @ 2:08 AM
Study NCT ID:
NCT04785105
Status:
COMPLETED
Last Update Posted:
2021-03-05
First Post:
2020-06-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Natural History of Asymptomatic Superior Mesenteric Arterial Stenosis.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003251', 'term': 'Constriction, Pathologic'}], 'ancestors': [{'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 77}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2020-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-04', 'studyFirstSubmitDate': '2020-06-22', 'studyFirstSubmitQcDate': '2021-03-04', 'lastUpdatePostDateStruct': {'date': '2021-03-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Development of mesenteric disease defined as acute mesenteric ischemia or chronic mesenteric ischemia.', 'timeFrame': '4 years'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['SMA', 'Stenosis', 'Stenosis on scanner'], 'conditions': ['Stenosis']}, 'descriptionModule': {'briefSummary': 'The aim of this study was to evaluate asymptomatic superior mesenteric artery (SMA) stenosis prognosis according to the presence of coeliac artery (CA) and/or inferior mesenteric artery (IMA) associated stenosis.', 'detailedDescription': 'BACKGROUND: The benefit of preventive treatment for SMA stenosis remains uncertain. The latest guidelines remain unclear given the lack of data in the literature.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '* patients with isolated \\>70% SMA stenosis\n* patients with both SMA stenosis and CA or/and IMA \\>70% stenosis', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* the presence of coeliac artery (CA) and/or inferior mesenteric artery (IMA) associated stenosis.\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT04785105', 'briefTitle': 'Natural History of Asymptomatic Superior Mesenteric Arterial Stenosis.', 'organization': {'class': 'OTHER', 'fullName': 'Hospices Civils de Lyon'}, 'officialTitle': 'Natural History of Asymptomatic Superior Mesenteric Arterial Stenosis Depends on Celiac and Inferior Mesenteric Arteries Status.', 'orgStudyIdInfo': {'id': 'SMA_2020'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'patient with isolated SMA stenosis', 'description': 'patient with isolated SMA stenosis on initial scanner', 'interventionNames': ['Other: No intervention']}, {'label': 'patient with both SMA stenosis and CA or/and IMA stenosis', 'description': 'patient with both SMA stenosis and CA or/and IMA stenosis on initial scanner', 'interventionNames': ['Other: No intervention']}], 'interventions': [{'name': 'No intervention', 'type': 'OTHER', 'description': 'No intervention', 'armGroupLabels': ['patient with both SMA stenosis and CA or/and IMA stenosis', 'patient with isolated SMA stenosis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69500', 'city': 'Bron', 'country': 'France', 'facility': 'Groupement Hospitalier Est', 'geoPoint': {'lat': 45.73865, 'lon': 4.91303}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}