Ignite Creation Date:
2025-12-24 @ 1:14 PM
Ignite Modification Date:
2025-12-29 @ 11:46 AM
Study NCT ID:
NCT05699395
Status:
UNKNOWN
Last Update Posted:
2023-01-26
First Post:
2022-11-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Quick Recognition of Aortic Dissection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000784', 'term': 'Aortic Dissection'}], 'ancestors': [{'id': 'D000094665', 'term': 'Dissection, Blood Vessel'}, {'id': 'D000783', 'term': 'Aneurysm'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D000094683', 'term': 'Acute Aortic Syndrome'}, {'id': 'D001018', 'term': 'Aortic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 600}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2025-05-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-01-25', 'studyFirstSubmitDate': '2022-11-23', 'studyFirstSubmitQcDate': '2023-01-25', 'lastUpdatePostDateStruct': {'date': '2023-01-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diagnosis of aortic dissection', 'timeFrame': 'First 24-hours during emergency dapartment stay', 'description': 'aortic dissection confirmed by CTA'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Aortic Dissection']}, 'descriptionModule': {'briefSummary': 'This is an observational study that establishes a cohort of patients with high risk chest pain who have been identified by CTA for aortic dissection. We then used this cohort to validate the accuracy of identifying aortic dissection based on extremity oximetry and Doppler waveforms.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'High risk chest pain patients', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* High risk chest pain with CTA\n\nExclusion Criteria:\n\n* shock\n* coma\n* severe peripheral vascular diseases'}, 'identificationModule': {'nctId': 'NCT05699395', 'briefTitle': 'Quick Recognition of Aortic Dissection', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Zhongshan Hospital'}, 'officialTitle': 'Identification of Aortic Dissection Based on Pulse Oxygen and Ultrasound Doppler Waveforms', 'orgStudyIdInfo': {'id': 'QRAD2022'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Aortic Dissection', 'interventionNames': ['Diagnostic Test: Non interventional']}, {'label': 'Non Aortic Dissection', 'interventionNames': ['Diagnostic Test: Non interventional']}], 'interventions': [{'name': 'Non interventional', 'type': 'DIAGNOSTIC_TEST', 'description': 'No intervention', 'armGroupLabels': ['Aortic Dissection', 'Non Aortic Dissection']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Shanghai', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jingchao Luo, MD', 'role': 'CONTACT', 'email': 'sucapter@163.com', 'phone': '13121021484'}], 'facility': 'Zhongshan Hospital, Fudan University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Zhongshan Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}