Ignite Creation Date:
2025-12-26 @ 10:46 PM
Ignite Modification Date:
2026-01-04 @ 3:42 AM
Study NCT ID:
NCT02630212
Status:
UNKNOWN
Last Update Posted:
2019-02-05
First Post:
2015-12-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Relationship Between ALDH2 and 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': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': '4 ml vein blood samples were collected from aortic dissection or controls in tubes containing EDTA. The samples would be centrifuged and saved in a -80℃ ultra-low temperature refrigerator.\n\n1 cm2 of aorta specimen were collected from patients operated on for Type A dissection, and refrigerated with liquid nitrogen.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-12', 'completionDateStruct': {'date': '2019-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-02-01', 'studyFirstSubmitDate': '2015-12-07', 'studyFirstSubmitQcDate': '2015-12-10', 'lastUpdatePostDateStruct': {'date': '2019-02-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-12-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients with different ALDH2 genotype', 'timeFrame': '1-30 days after samples collected', 'description': 'DNA was extracted from venous blood;genomic DNA underwent PCR amplification; finally, PCR products were purified and directly sequenced by Invitrogen Corp or Biosune Corp.Then ALDH2 genotype was distinguished depend on a G-to-A missense mutation on exon 12 of ALDH2 gene.'}], 'secondaryOutcomes': [{'measure': 'Concentration of inflammatory factors in blood and aortic specimen', 'timeFrame': '1-30 days after samples collected', 'description': 'Concentration of 4-HNE、MMP-2、MMP-9 detected by elisa kit、IHC or western blot in relevant specimen.'}, {'measure': 'ALDH2 activity', 'timeFrame': '1-30 days after samples collected', 'description': 'Activity of ALDH2 was detected in blood and aortic specimen depend on its reducibility of NAD+'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Aortic dissection', 'Aldehyde dehydrogenase 2 polymorphism', 'Risk factor', 'aldehyde dehydrogenase 2'], 'conditions': ['Aortic Dissection']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the impact of ALDH2 Glu504Lys polymorphism on aortic dissection.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Consecutive patients diagnosed with aortic dissection in Qilu Hospital.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Chinese Han people diagnosed with aortic dissection in Qilu Hospital\n\nExclusion Criteria:\n\n* Aortic dissection based on trauma, connective tissue diseases and pregnancy\n* Patients with tumor\n* Patients with no written consensus'}, 'identificationModule': {'nctId': 'NCT02630212', 'acronym': 'RALAD', 'briefTitle': 'The Relationship Between ALDH2 and Aortic Dissection', 'organization': {'class': 'OTHER', 'fullName': 'Qilu Hospital of Shandong University'}, 'officialTitle': 'The Relationship Between ALDH2 and Aortic Dissection', 'orgStudyIdInfo': {'id': '2015QLMS37'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Control', 'description': 'Chinese Han people undergoing coronary angiography in Qilu Hospital in corresponding period whose coronary arteries narrowing less than 50 percent.'}, {'label': 'Aortic dissection', 'description': 'Chinese Han people diagnosed with aortic dissection in Qilu Hospital'}]}, 'contactsLocationsModule': {'locations': [{'zip': '250012', 'city': 'Jinan', 'state': 'Shandong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yuguo Chen, M.D., Ph.D.', 'role': 'CONTACT', 'email': 'chen919085@126.com', 'phone': '86-18678812777'}, {'name': 'Yuguo Chen, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Qilu Hospital of Shandong University', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Qilu Hospital of Shandong University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}