Ignite Creation Date:
2025-12-25 @ 1:32 AM
Ignite Modification Date:
2025-12-25 @ 11:52 PM
Study NCT ID:
NCT05945394
Status:
UNKNOWN
Last Update Posted:
2023-09-13
First Post:
2023-06-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Surem TRAF3IP2 Level and Atherosclerotic Plaque Development in Human
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003327', 'term': 'Coronary Disease'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'The blood sample will be collected, and the surem TRAF3IP2 levels will be measured using ELASA.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 800}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-09-08', 'studyFirstSubmitDate': '2023-06-29', 'studyFirstSubmitQcDate': '2023-07-13', 'lastUpdatePostDateStruct': {'date': '2023-09-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'stenosis of coronary artery', 'timeFrame': '1 week', 'description': 'The stenosis of coronary artery based on the results of coronary angiography'}], 'secondaryOutcomes': [{'measure': 'coronary artery calcium', 'timeFrame': '1 week', 'description': 'The coronary artery calcification based on the results of coronary angiography'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['TRAF3IP2, Coronary angiography, coronary deart disease'], 'conditions': ['Coronary Heart Disease, Susceptibility to, 1']}, 'descriptionModule': {'briefSummary': 'To evaluate the association of surem TRAF3IP2 levels with the atherosclerotic plaque development in human', 'detailedDescription': 'Previous study had concluded that TRAF3IP2 plays a causal role in atherosclerotic plaque development and vulnerability in mice. However, no human data was available. In the present study, patients who receive coronary angiography will be enrolled. Their surem TRAF3IP2 levels will be tested using ELASA. The association of surem TRAF3IP2 levels with the atherosclerotic plaque will be evaluated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with suspected coronary heart disease who experienced coronary angiography', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients with suspected coronary heart disease\n2. patients received coronary angiography\n\nExclusion Criteria:\n\n1. NYHA III-IV\n2. malignant tumor\n3. acute infection\n4. thyroid dysfunction'}, 'identificationModule': {'nctId': 'NCT05945394', 'briefTitle': 'The Surem TRAF3IP2 Level and Atherosclerotic Plaque Development in Human', 'organization': {'class': 'OTHER', 'fullName': 'Nanjing Medical University'}, 'officialTitle': 'The Surem TRAF3IP2 Level and Atherosclerotic Plaque Development in Human', 'orgStudyIdInfo': {'id': '20230503'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with suspected CHD who experienced CAG', 'description': 'Patients with suspected coronary heart disease who experienced coronary angiography', 'interventionNames': ['Other: No intervention']}], 'interventions': [{'name': 'No intervention', 'type': 'OTHER', 'description': 'This is an obvertional study, and there is no intervention.', 'armGroupLabels': ['Patients with suspected CHD who experienced CAG']}]}, 'contactsLocationsModule': {'locations': [{'zip': '223300', 'city': "Huai'an", 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiaozhong Yang, MD.', 'role': 'CONTACT'}], 'facility': "Huai'an First People's Hospital", 'geoPoint': {'lat': 33.58861, 'lon': 119.01917}}], 'centralContacts': [{'name': 'Geng Jin, MD', 'role': 'CONTACT', 'email': 'gj885258@163.com', 'phone': '+86-17753124846'}], 'overallOfficials': [{'name': 'Ma Shuren, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'NJMU'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nanjing Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'associate doctor', 'investigatorFullName': 'Jin Geng', 'investigatorAffiliation': 'Nanjing Medical University'}}}}