Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2025-12-25 @ 11:56 PM
Study NCT ID:
NCT06038994
Status:
UNKNOWN
Last Update Posted:
2023-09-15
First Post:
2023-09-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prognostic Value of Surem TRAF3IP2 Level in Patients With Acute Myocardial Infarction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009203', 'term': 'Myocardial Infarction'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009336', 'term': 'Necrosis'}]}}, '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': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2025-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-09-08', 'studyFirstSubmitDate': '2023-09-07', 'studyFirstSubmitQcDate': '2023-09-08', 'lastUpdatePostDateStruct': {'date': '2023-09-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'MACEs (major adverse cardiac events)', 'timeFrame': '1 year', 'description': 'MACEs were defined as a composite of cardiac death, hospitalization for myocardial infarction or heart failure'}], 'secondaryOutcomes': [{'measure': 'cardiac death', 'timeFrame': '1 year', 'description': 'and death due to cardiac reasons, such as myocardial infarction or heart failure'}, {'measure': 'hospitalization for myocardial infarction or heart failure', 'timeFrame': '1 year', 'description': 'hospitalization for myocardial infarction or heart failure'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['TRAF3IP2, Myocardial Infarction, Coronary angiography, MACEs'], 'conditions': ['Myocardial Infarction, Acute']}, 'descriptionModule': {'briefSummary': 'To evaluate the prognostic value of surem TRAF3IP2 levels in patients with acute myocardial infarction', '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 diagnosed with acute myocardial infarction who receive coronary angiography will be enrolled. Their surem TRAF3IP2 levels will be tested using ELASA. The association of surem TRAF3IP2 levels with the major adverse cardiac events will be evaluated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': "All patients with acute myocardial infarction who received coronary angiography well enrolled in Huai'an First People's Hospital", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients with acute myocardial infarction\n2. patients received coronary angiography\n3. invasive management within 72 h of hospital admission\n\nExclusion Criteria:\n\n1. NYHA III-IV\n2. malignant tumor\n3. acute infection\n4. thyroid dysfunction\n5. Life expectancy of b1 y\n6. Unsuitable for PCI'}, 'identificationModule': {'nctId': 'NCT06038994', 'briefTitle': 'Prognostic Value of Surem TRAF3IP2 Level in Patients With Acute Myocardial Infarction', 'organization': {'class': 'OTHER', 'fullName': 'Nanjing Medical University'}, 'officialTitle': 'Prognostic Value of Surem TRAF3IP2 Level in Patients With Acute Myocardial Infarction', 'orgStudyIdInfo': {'id': '20230901'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with acute myocardial infarction who experienced CAG', 'description': 'Patients with acute myocardial infarction 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 acute myocardial infarction who experienced CAG']}]}, 'contactsLocationsModule': {'locations': [{'zip': '223300', 'city': "Huai'an", 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiaozhong Yang, MD.', 'role': 'CONTACT', 'phone': '+8684922412'}], 'facility': "Huai'an First People's Hospital", 'geoPoint': {'lat': 33.58861, 'lon': 119.01917}}], 'centralContacts': [{'name': 'Jin Geng, MD.', 'role': 'CONTACT', 'email': 'gj885258@163.com', 'phone': '+86-17753124846'}], 'overallOfficials': [{'name': 'Shuren Ma, MD.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'NJMU'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'There is not a plan to make IPD available.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nanjing Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'associate doctor', 'investigatorFullName': 'Jin Geng', 'investigatorAffiliation': 'Nanjing Medical University'}}}}