Ignite Creation Date:
2025-12-24 @ 7:36 PM
Ignite Modification Date:
2026-01-04 @ 8:54 AM
Study NCT ID:
NCT02852603
Status:
COMPLETED
Last Update Posted:
2021-04-13
First Post:
2016-07-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study on Genetically Affected Sporadic Thoracic Aortic Aneurysm and Dissection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000784', 'term': 'Aortic Dissection'}, {'id': 'D001014', 'term': 'Aortic Aneurysm'}, {'id': 'D000783', 'term': 'Aneurysm'}], 'ancestors': [{'id': 'D000094665', 'term': 'Dissection, Blood Vessel'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D000094683', 'term': 'Acute Aortic Syndrome'}, {'id': 'D001018', 'term': 'Aortic Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Peripheral whole blood is obtained from patients. Serum, blood cell and DNA are separated and stored for further study.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 450}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2020-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-11', 'studyFirstSubmitDate': '2016-07-27', 'studyFirstSubmitQcDate': '2016-08-01', 'lastUpdatePostDateStruct': {'date': '2021-04-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-08-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Numbers of patients having thoracic aortic aneurysm and/or dissection are recorded. Diagnosis are confirmed by imaging analysis (CTA and/or Ultrasound) or by doctors during the operations.', 'timeFrame': '6 months', 'description': 'Arterial dissection actually happened'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['dissection', 'aneurysm', 'thoracic aorta'], 'conditions': ['Dissection of Aorta, Thoracic', 'Aneurysm of Aorta, Thoracic']}, 'descriptionModule': {'briefSummary': 'Mortality of thoracic aortic aneurysm and dissection (TAAD) remains high because of the huge blood lost from the aorta. Questions about the potentially genetic effects on sporadic TAAD are raised by researchers to explore the possible mechanisms leading to sporadic TAAD and to establish new clinical approaches to prevent TAAD-caused adverse clinical outcomes. This study is intended to collect the gene information in sporadic TAAD patients and to explore the relationship between genetic variation and the incidence of sporadic TAAD for further study.', 'detailedDescription': "Thoracic aortic dissection (TAD) is a critical clinical condition partly due to the rupture of aortic aneurysm. Mostly, surgical treatment can reduce the symptoms and extend life span of patients with thoracic aortic aneurysm and dissection (TAAD). However, mortality of TAAD remains high because of the huge blood lost from the aorta. Sporadic TAAD was considered to be a server consequence of hypertension, though most patients with hypertension won't have TAAD as their final outcomes. Previous studies have revealed the associations between genetic abnormalities and familial TAAD, and genetic tests have applied to assist the diagnosis of certain TAAD. Therefore, the potentially genetic effects on sporadic TAAD are explored by researchers to understand the possible mechanisms leading to sporadic TAAD and to establish new clinical approaches to prevent TAAD-caused adverse clinical outcomes. This study is intended to collect the gene information in sporadic TAAD patients and to explore the relationship between genetic variation and the incidence of sporadic TAAD for further study."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with thoracic aortic aneurysm and dissection.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with thoracic aortic aneurysm and dissection not due to trauma\n\nExclusion Criteria:\n\n* Inability of the patient, parent or guardian to give consent\n* Unwillingness to provide a blood specimen or participate in the study'}, 'identificationModule': {'nctId': 'NCT02852603', 'acronym': 'GenSTAND', 'briefTitle': 'Study on Genetically Affected Sporadic Thoracic Aortic Aneurysm and Dissection', 'organization': {'class': 'OTHER', 'fullName': 'Wuhan Asia Heart Hospital'}, 'officialTitle': 'Study on Genetically Affected Sporadic Thoracic Aortic Aneurysm and Dissection', 'orgStudyIdInfo': {'id': '2016LMC-2'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'thoracic aortic aneurysm and dissection', 'description': 'Patients with thoracic aortic aneurysm and/or dissection are recruited in the study.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '430022', 'city': 'Wuhan', 'state': 'Hubei', 'country': 'China', 'facility': 'Wuhan Asia Heart Hospital', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}], 'overallOfficials': [{'name': 'Xuan Zheng, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wuhan Asia Heart Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wuhan Asia Heart Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fu Wai Hospital, Beijing, China', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'vice director of laboratory of molecular cardiology', 'investigatorFullName': 'Xuan Zheng', 'investigatorAffiliation': 'Wuhan Asia Heart Hospital'}}}}