Ignite Creation Date:
2025-12-24 @ 6:44 PM
Ignite Modification Date:
2026-01-02 @ 3:10 PM
Study NCT ID:
NCT07100457
Status:
RECRUITING
Last Update Posted:
2025-08-03
First Post:
2025-07-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
OR6A2 on Monocytes and Cardiovascular Outcomes in Myocardial Ischemia-Reperfusion Injury
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-04-20', 'size': 406041, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-07-24T03:08', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'targetDuration': '44 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2027-08-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-30', 'studyFirstSubmitDate': '2025-07-24', 'studyFirstSubmitQcDate': '2025-07-30', 'lastUpdatePostDateStruct': {'date': '2025-08-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-08-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Major Adverse Cardiovascular Events', 'timeFrame': 'From enrollment to 44 months after reperfusion injury', 'description': 'Major Adverse Cardiovascular Events (MACEs) defined as the composite endpoint of recurrent acute myocardial infarction, cardiac death, stroke, hospitalization for unstable angina, or unplanned coronary revascularization.'}], 'secondaryOutcomes': [{'measure': 'Serum IL-1α Level', 'timeFrame': 'Baseline (within 24 hours after confirmed myocardial ischemia-reperfusion injury)', 'description': 'Units: pg/mL'}, {'measure': 'Serum IL-1β Level', 'timeFrame': 'Baseline (within 24 hours after confirmed myocardial ischemia-reperfusion injury)', 'description': 'Units: pg/mL'}, {'measure': 'Plasma Malondialdehyde (MDA) Level', 'timeFrame': 'Baseline (within 24 hours after confirmed myocardial ischemia-reperfusion injury)', 'description': 'Units: μmol/L'}, {'measure': 'Plasma Hydrogen Peroxide (H₂O₂) Level', 'timeFrame': 'Baseline (within 24 hours after confirmed myocardial ischemia-reperfusion injury)', 'description': 'Units: μmol/L'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Myocardial Ischemia-Reperfusion Injury']}, 'descriptionModule': {'briefSummary': "This study examines how the interaction between octanal (an OR6A2 receptor activator) and OR6A2 expression influences inflammation and clinical outcomes in Myocardial Ischemia-Reperfusion Injury patients. We analyze two key relationships: 1) The octanal-OR6A2 pathway's association with systemic oxidative stress/inflammatory biomarkers, and 2) How OR6A2 expression patterns on monocyte subtypes and plasma octanal levels correlate with major cardiovascular events. Patients undergoing this post-revascularization injury provided blood samples for OR6A2/octanal/inflammation measurements. IR Injury patients underwent 44-month clinical follow-up. Results may identify biological markers for personalized risk assessment after revascularization therapies. Ethics approval: Zhongda Hospital #2020ZDSYLL051-P01."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The study population consists of consecutively enrolled participants with myocardial ischemia-reperfusion injury who are recruited from the Department of Cardiology at Zhongda Hospital, Southeast University, China.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Acute myocardial infarction (AMI) patients with angiographically-confirmed coronary artery disease undergoing primary percutaneous coronary intervention (PCI), and subsequently diagnosed with protocol-defined myocardial ischemia-reperfusion injury during the post-PCI period.\n2. Age 18-90 years inclusive.\n\nExclusion Criteria:\n\n1. Active systemic infections.\n2. Advanced heart failure (NYHA class III-IV).\n3. Acute cerebrovascular conditions.\n4. Active myocarditis.\n5. cardiomyopathy.\n6. Refractory ventricular tachycardia/fibrillation.\n7. Diagnosis/concurrent treatment for malignancy within 5 years (except non-melanoma skin cancer/carcinoma in situ).\n8. Severe renal insufficiency (estimated glomerular filtration rate \\[eGFR\\] \\<30 mL/min/1.73m2 or dialysis dependence).\n9. Child-Pugh class C hepatic dysfunction.'}, 'identificationModule': {'nctId': 'NCT07100457', 'briefTitle': 'OR6A2 on Monocytes and Cardiovascular Outcomes in Myocardial Ischemia-Reperfusion Injury', 'organization': {'class': 'OTHER', 'fullName': 'Southeast University, China'}, 'officialTitle': 'Association of OR6A2 Expression on Monocytes With Inflammation and Major Adverse Cardiovascular Events in Myocardial Ischemia-Reperfusion Injury', 'orgStudyIdInfo': {'id': '2020ZDSYLL051-P01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients With Myocardial Ischemia-Reperfusion Injury', 'interventionNames': ['Diagnostic Test: Blood Biomarker Profiling and Prognostic Follow-up']}], 'interventions': [{'name': 'Blood Biomarker Profiling and Prognostic Follow-up', 'type': 'DIAGNOSTIC_TEST', 'description': 'Peripheral venous blood collection for in-vitro quantification of serum biomarkers (including octanal, OR6A2, and inflammatory mediators) via mass spectrometry/ELISA/flow cytometry, coupled with longitudinal surveillance of Major Adverse Cardiovascular Events (MACEs) using hospital records, patient interviews, and adjudicated endpoint verification during scheduled follow-up visits.', 'armGroupLabels': ['Patients With Myocardial Ischemia-Reperfusion Injury']}]}, 'contactsLocationsModule': {'locations': [{'zip': '210009', 'city': 'Nanjing', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Tingting Xiao, M.D.', 'role': 'CONTACT', 'email': '230249327@seu.edu.cn', 'phone': '+86 16605198956'}], 'facility': 'Department of Cardiology, Zhongda Hospital, Southeast University', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}], 'centralContacts': [{'name': 'Wenbin Lu, PhD', 'role': 'CONTACT', 'email': '101012092@seu.edu.cn', 'phone': '+86 13605185175'}, {'name': 'Yahao Zhang, M.D.', 'role': 'CONTACT', 'email': 'zhyh626@163.com', 'phone': '+86 13523060936'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Southeast University, China', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of Cardiovascular Medicine & Deputy Director of Cardiovascular Disease Research Institute, Zhongda Hospital Southeast University; Professor (Level-II); Chief Physician; PhD Advisor; Chairman, Cardiovascular Society of Jiangsu Medical Association', 'investigatorFullName': 'Genshan Ma', 'investigatorAffiliation': 'Southeast University, China'}}}}