Ignite Creation Date:
2025-12-24 @ 10:52 PM
Ignite Modification Date:
2025-12-30 @ 8:46 AM
Study NCT ID:
NCT05409469
Status:
COMPLETED
Last Update Posted:
2022-06-08
First Post:
2022-05-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Characteristics, Management Patterns and Outcomes of Type A Aortic Dissection: A Sino-US Comparative Cohort Analysis
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 11550}, 'targetDuration': '5 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2021-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-06-05', 'studyFirstSubmitDate': '2022-05-20', 'studyFirstSubmitQcDate': '2022-06-05', 'lastUpdatePostDateStruct': {'date': '2022-06-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Baseline data of patients with type A aortic dissection was assessed by SPSS 17.0', 'timeFrame': 'from 2015 to 2019', 'description': 'Baseline data of patients with type A aortic dissection included gender, age,height, weight, past medical history, family history, hospital costs, etc.'}, {'measure': 'The main efficacy indicators was assessed by SPSS 17.0.', 'timeFrame': 'from 2015 to 2019', 'description': 'The main efficacy indicators included surgical procedures, surgical outcome (postoperative bleeding, ICU stay, extubation time), perioperative complications (including infection, bleeding, neurological complications, cardic complications, renal insufficiency, etc.), and postoperative mortality.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Aortic Dissection', 'China', 'the United States'], 'conditions': ['Aortic Dissection']}, 'descriptionModule': {'briefSummary': 'This study constructed a retrospective cohort study by retrospectively analyzing the data of all patients with aortic dissection from January 1, 2012 to December 31, 2021 from the Cardiovascular Disease Registration System of Jiangsu Province in China and the data of similar diseases in recent years from National Inpatient Sample database in the United States'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All patients with aortic dissection in Jiangsu Aortic Registry system of China from January 2012 to December 2021 and all patients with aortic dissection in National Inpatient Sample database of the United States from January 2015 to December 2019.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1.Clinical diagnosis of type A Aortic Dissection\n\nExclusion Criteria:\n\n1. age\\<18, age unknown,\n2. diagnosis of aortic aneurysm, transfer out within 1 day,\n3. unknown vital status at discharge;\n4. unknown treatment type: cardioplegia, valve or cardiac repair only without aortic repair or two types of treatments on different days'}, 'identificationModule': {'nctId': 'NCT05409469', 'briefTitle': 'Clinical Characteristics, Management Patterns and Outcomes of Type A Aortic Dissection: A Sino-US Comparative Cohort Analysis', 'organization': {'class': 'OTHER', 'fullName': 'Nanjing First Hospital, Nanjing Medical University'}, 'officialTitle': 'Clinical Characteristics, Management Patterns and Outcomes of Type A Aortic Dissection: A Sino-US Comparative Cohort Analysis', 'orgStudyIdInfo': {'id': 'NanjingFirst AAD'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Chinese patients with aortic dissection', 'description': 'Clinical characteristics, management patterns and outcomes of type A aortic dissection in China.', 'interventionNames': ['Procedure: surgery']}, {'label': 'American patients with aortic dissection', 'description': 'Clinical characteristics, management patterns and outcomes of type A aortic dissection in the United States.', 'interventionNames': ['Procedure: surgery']}], 'interventions': [{'name': 'surgery', 'type': 'PROCEDURE', 'description': 'surgery on patients with aortic dissection', 'armGroupLabels': ['American patients with aortic dissection', 'Chinese patients with aortic dissection']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xin Chen', 'class': 'OTHER'}, 'collaborators': [{'name': 'China Medical University, China', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'Xin Chen', 'investigatorAffiliation': 'Nanjing First Hospital, Nanjing Medical University'}}}}