Ignite Creation Date:
2025-12-24 @ 9:45 PM
Ignite Modification Date:
2026-01-02 @ 12:01 AM
Study NCT ID:
NCT04004832
Status:
UNKNOWN
Last Update Posted:
2020-09-21
First Post:
2019-05-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of the Severity of Coronary Atherosclerosis With Tissue Compliance in Patients Within First Degree Relatives
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'C564258', 'term': 'Coronary Artery Disease, Autosomal Dominant, 1'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'blood sample'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'FAMILY_BASED'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-09-18', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2021-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-09-18', 'studyFirstSubmitDate': '2019-05-28', 'studyFirstSubmitQcDate': '2019-06-29', 'lastUpdatePostDateStruct': {'date': '2020-09-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'relation between HLA subgroups and severity and prevelance of coronary artery lesions', 'timeFrame': '20 MAY 2019 - 30 MAY 2019', 'description': 'the hla similarity of two sibling patient %80 and the military syntax score %97,7'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Coronary Artery Disease With Myocardial Infarction']}, 'referencesModule': {'references': [{'pmid': '28624488', 'type': 'BACKGROUND', 'citation': 'Xiong Y, Wang L, Mo P, Huang G, Li A, Chai R, Lin X, Zhong Y, Liu B, Ou W, Liu B, Liu SM. Association between HLA-DQB1 alleles and susceptibility to coronary artery disease in Southern Han Chinese. Hum Immunol. 2017 Sep;78(9):540-546. doi: 10.1016/j.humimm.2017.06.003. Epub 2017 Jun 15.'}]}, 'descriptionModule': {'briefSummary': 'This study research the similarity of coronary artery lesions according to HLA tissue compatibility in fisrt degree relatives of the patients who just admitted clinic as Acute coronary syndrome and underwent angiyography before .', 'detailedDescription': 'Coronary artery disease (CAD), which is mainly caused by atherosclerosis, is the most prevalent illness and the leading cause of death worldwide. Increasing evidence suggests that inflammation plays a primordial role in atherogenesis and is closely associated with the major histocompatibility complex (MHC) (human leukocyte antigen \\[HLA\\] in humans) molecules. HLA genes are located in 6p21.3, the proteins encoded by these HLA genes have a major role to play in antigen presentation and inflammatory pathways. HLA involvement in inflammation is mainly associated with the HLA-dependent activation of T cells. studies reported that the susceptibility to CAD is related with the polymorphisms in HLA-DRB1. The above evidence indicates that the polymorphisms in HLA class II are associated with the risk of CAD . This study research investigate three objects , firstly what is the similarity of the coronary artery lesions according to the compatability of HLA alleles between the first degree relatives who went angiography before , secondly is there any relation between HLA subtype allels and the coronary artery (RCA ?LAD ? ,CX? and can such a relation be responsible from the lesions in this artery ,finally is there any relation between HLA subtypes and turkish race coronary artery disease'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '* male or female with age between 18-70\n* hospital admission due to acute coronary syndrome with first degree relative history who had coronary angiyography before', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* male or female with age between 18-70\n* hospital admission due to acute coronary syndrome with first degree relative history who had coronary angiyography before\n\nExclusion Criteria:\n\n* first degree relative without any angiyography history before for patients who admitted as acute coronary syndrome'}, 'identificationModule': {'nctId': 'NCT04004832', 'briefTitle': 'Comparison of the Severity of Coronary Atherosclerosis With Tissue Compliance in Patients Within First Degree Relatives', 'organization': {'class': 'OTHER', 'fullName': 'TC Erciyes University'}, 'officialTitle': 'Comparison of the Severity and Prevalence of Coronary Atherosclerosis With Tissue Compliance (HLA Similarity ) in Patients Within First Degree Relatives', 'orgStudyIdInfo': {'id': '2018/543'}}, 'armsInterventionsModule': {'interventions': [{'name': 'there is not any intervention procedure', 'type': 'DIAGNOSTIC_TEST', 'description': 'there is not any intervention procedure'}]}, 'contactsLocationsModule': {'locations': [{'zip': '38200', 'city': 'Kayseri', 'state': 'Melikgazi', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Zeki Çetinkaya', 'role': 'CONTACT', 'email': 'zcetinkaya@erciyes.edu.tr', 'phone': '+90 5393165950'}], 'facility': 'Zeki Çetinkaya', 'geoPoint': {'lat': 38.73222, 'lon': 35.48528}}], 'centralContacts': [{'name': 'Zeki Çetinkaya', 'role': 'CONTACT', 'email': 'zeki2387@gmail.com', 'phone': '+905393165950'}], 'overallOfficials': [{'name': 'Zeki Çetinkaya', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Doctor'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'TC Erciyes University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Zeki Çetinkaya', 'investigatorAffiliation': 'TC Erciyes University'}}}}