Ignite Creation Date:
2025-12-24 @ 9:07 PM
Ignite Modification Date:
2025-12-25 @ 6:58 PM
Study NCT ID:
NCT04239404
Status:
UNKNOWN
Last Update Posted:
2020-01-27
First Post:
2020-01-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prognostic Impact of PMI in Stable CAD Undergoing PCI
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood samples of the participants before and after percutaneous coronary intervention therapy were selected.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2021-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-01-20', 'studyFirstSubmitDate': '2020-01-20', 'studyFirstSubmitQcDate': '2020-01-20', 'lastUpdatePostDateStruct': {'date': '2020-01-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Major cardiac events', 'timeFrame': '12 months after PCI', 'description': 'cardiac death, target vessel revascularization, target lesion revascularization, non-fatal myocardial infarction, heart failure, angina pectoris'}], 'secondaryOutcomes': [{'measure': 'Serum level of inflammatory factors', 'timeFrame': '1 day after PCI', 'description': 'Serum level of inflammatory factors including TNFα, IL-6 and so on.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Periprocedural Myocardial Injury', 'Coronary Artery Disease', 'Percutaneous Coronary Intervention']}, 'descriptionModule': {'briefSummary': 'This is a single-center, observational, prospective study. This study aims to observe the effect of periprocedural myocardial injury on cardiovascular events in patients undergoing elective percutaneous coronary intervention, and to detect the levels of serum inflammatory factors before and after intervention to predict the occurrence of periprocedural myocardial injury and its association with cardiovascular events.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'In-patients with stable coronary artery disease undergoing elective percutaneous coronary intervention in Zhongshan Hospital will be enrolled.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* underwent elective coronary stenting\n* patients permit informed consents\n\nExclusion Criteria:\n\n* acute STEMI\n* NYHA class III-IV heart failure\n* moderate-to-severe valvular disease\n* missing post-PCI troponin results\n* active infection, respiratory failure\n* liver dysfunction (liver enzyme \\>3xURL or bilirubin \\>2xURL),\n* malignancy and systemic connective tissue disease\n* unable to get a informed consents'}, 'identificationModule': {'nctId': 'NCT04239404', 'briefTitle': 'Prognostic Impact of PMI in Stable CAD Undergoing PCI', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Zhongshan Hospital'}, 'officialTitle': 'The Prognostic Impact of Periprocedural Myocardial Injury in Stable Coronary Artery Disease Patients Undergoing Elective Percutaneous Coronary Intervention', 'orgStudyIdInfo': {'id': 'PMI-CAD-PCI'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'PMI'}, {'label': 'non-PMI'}]}, 'contactsLocationsModule': {'locations': [{'zip': '200032', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'facility': '180 Fenglin Road', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Zhangwei Chen, MD', 'role': 'CONTACT', 'email': 'chen.zhangwei@zs-hospital.sh.cn', 'phone': '+86 21 64041990'}, {'name': 'Danbo Lu, PhD', 'role': 'CONTACT', 'email': 'lu.danbo@zs-hospital.sh.cn', 'phone': '+86 21 64041990'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Zhongshan Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}