Ignite Creation Date:
2025-12-25 @ 4:12 AM
Ignite Modification Date:
2025-12-26 @ 3:11 AM
Study NCT ID:
NCT06669520
Status:
RECRUITING
Last Update Posted:
2024-11-01
First Post:
2024-10-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Correlation of Blood Serum Renalase and Microcirculation Obstruction in Patients with Acute Myocardial Infarction After Primary Percutaneous Coronary Intervention
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-30', 'studyFirstSubmitDate': '2024-10-29', 'studyFirstSubmitQcDate': '2024-10-30', 'lastUpdatePostDateStruct': {'date': '2024-11-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants with Microvascular Obstruction Assessed by Contrast-Enhanced Magnetic Resonance Imaging 3-7 Days After Percutaneous Coronary Intervention.', 'timeFrame': '3-7 days after PPCI', 'description': 'Microvascular obstruction (MVO) was qualitatively recognized as a subendocardial lack of enhancement at first-pass perfusion (FPP) sequences and as a hypointense region within the hyperintense infarcted area at early gadolinium enhancement (EGE) and late gadolinium enhancement (LGE) sequences.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute Myocardial Infarction']}, 'referencesModule': {'references': [{'pmid': '41314850', 'type': 'DERIVED', 'citation': 'Chen Y, Li R, Fu R, Zhao L, Sheng Z, Xu K, Liu J, Huang W, Wen J, Zeng L, Ou Z, Jiang Z, Liu Y, Wang Y, Jiang W, Li X. Association between periprocedural change in serum renalase and microvascular obstruction in patients with STEMI after primary percutaneous coronary intervention: protocol for the ReMVOS prospective cohort study. BMJ Open. 2025 Nov 28;15(11):e110045. doi: 10.1136/bmjopen-2025-110045.'}]}, 'descriptionModule': {'briefSummary': 'This research will explore the association between blood serum renalase and microcirculation obstruction in patients with acute myocardial infarction (AMI) after primary percutaneous coronary intervention (PCI). The investigators aim to identify potential risk factors for microcirculation obstruction in AMI patients after PPCI.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population will include 200 patients diagnosed with acute myocardial infarction (AMI) who will undergo primary percutaneous coronary intervention (PCI) at the Third Xiangya Hospital of Central South University, from August 2024 to August 2025.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age ≥ 18 years;\n2. STEMI symptom onset time \\< 12 hours;\n3. STEMI symptom onset time 12-48 hours with persistent ischemic symptoms, hemodynamic instability, or life-threatening ventricular arrhythmias;\n4. High-risk NSTEMI;\n5. Emergency PCI;\n6. Voluntary informed consent.\n\nExclusion Criteria:\n\n1. Non-obstructive acute myocardial infarction;\n2. Severe chronic kidney disease (defined as estimated glomerular filtration rate \\< 20 mL/min per 1.73 m²);\n3. Life expectancy \\< 1 year;\n4. Pregnant or planning to become pregnant;\n5. Emergency PCI failure.'}, 'identificationModule': {'nctId': 'NCT06669520', 'briefTitle': 'Correlation of Blood Serum Renalase and Microcirculation Obstruction in Patients with Acute Myocardial Infarction After Primary Percutaneous Coronary Intervention', 'organization': {'class': 'OTHER', 'fullName': 'The Third Xiangya Hospital of Central South University'}, 'officialTitle': 'Correlation of Blood Serum Renalase and Microcirculation Obstruction in Patients with Acute Myocardial Infarction After Primary Percutaneous Coronary Intervention', 'orgStudyIdInfo': {'id': 'K 24655'}}, 'contactsLocationsModule': {'locations': [{'zip': '410013', 'city': 'Changsha', 'state': 'Hunan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Weihong Jiang, Doctor', 'role': 'CONTACT', 'email': 'jiangweihongdoc@163.com', 'phone': '0086-13786113632'}, {'name': 'Ye Chen, Master', 'role': 'CONTACT', 'email': 'chenye1223@126.com', 'phone': '0086-18674319338'}, {'name': 'Weihong Jiang, Doctor', 'role': 'CONTACT'}, {'name': 'Ye Chen, Master', 'role': 'CONTACT'}], 'facility': 'The Third Xiangya Hospital of Central South University', 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}], 'centralContacts': [{'name': 'Weihong Jiang', 'role': 'CONTACT', 'email': 'jiangweihongdoc@163.com', 'phone': '（86）13786113632'}, {'name': 'Ye Chen', 'role': 'CONTACT', 'email': 'chenye1223@126.com', 'phone': '（86）18674319338'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Third Xiangya Hospital of Central South University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}