Ignite Creation Date:
2025-12-25 @ 3:53 AM
Ignite Modification Date:
2025-12-26 @ 2:42 AM
Study NCT ID:
NCT05107102
Status:
COMPLETED
Last Update Posted:
2021-11-04
First Post:
2021-10-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Myocardial Work for Prediction of Left Ventricular Remodeling in Patients With STEMI
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020257', 'term': 'Ventricular Remodeling'}], 'ancestors': [{'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 98}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-09-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2021-08-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-24', 'studyFirstSubmitDate': '2021-10-24', 'studyFirstSubmitQcDate': '2021-10-24', 'lastUpdatePostDateStruct': {'date': '2021-11-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Delta-work efficiency by echocardiography', 'timeFrame': '24-72 hours after PCI', 'description': 'A novel tool for non-invasive myocardial work(MW) assessment has been introduced to evaluate myocardial performance.MW was calculated as a function of time through a combination of LV global longitudinal strain(GLS) data and an estimated LV pressure curves. Work efficiency (WE) was calculated from the ratio of the constructive work to the sum of constructive and wasted work, expressed as a percentage.The values of culprit regional WE was expressed as WE-LAD.The values of non-culprit regional WE was expressed as WE-nonLAD.The absolute differences of the WE was calculated as the values of non-culprit regional WE minus the values of culprit regional WE, and noted as delta-WE.'}], 'secondaryOutcomes': [{'measure': 'Global work index by echocardiography', 'timeFrame': '24-72 hours, 3-month after PCI', 'description': 'Global work index (GWI) is classified as total work within the area of the LV pressure-strain loop calculated from mitral valve closure to mitral valve opening.'}, {'measure': 'Global constructive work by echocardiography', 'timeFrame': '24-72 hours, 3-month after PCI', 'description': 'Global constructive work (GCW) was defined as work contributing to LV ejection performed during shortening in systole and work performed during lengthening in isovolumic relaxation.'}, {'measure': 'Global work efficiency by echocardiography', 'timeFrame': '24-72 hours, 3-month after PCI', 'description': 'Global work efficiency (GWE) was calculated from the ratio of the constructive work to the sum of constructive and wasted work, expressed as a percentage.'}, {'measure': 'Work index-LAD', 'timeFrame': '24-72 hours, 3-month after PCI', 'description': 'Work index in left anterior descending(LAD) territory.'}, {'measure': 'Constructive work-LAD', 'timeFrame': '24-72 hours, 3-month after PCI', 'description': 'constructive work in left anterior descending(LAD) territory.'}, {'measure': 'Work efficiency-LAD', 'timeFrame': '24-72 hours, 3-month after PCI', 'description': 'Work efficiency in left anterior descending(LAD) territory.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ST-segment elevated myocardial infarction', 'myocardial work', 'left ventricular remodeling'], 'conditions': ['ST-Segment Elevated Myocardial Infarction']}, 'referencesModule': {'references': [{'pmid': '35966524', 'type': 'DERIVED', 'citation': 'Wang W, Zhao H, Wan F, Shen XD, Ding S, Pu J. Inhomogeneous Distribution of Regional Myocardial Work Efficiency Predicts Early Left Ventricular Remodeling After Acute Anterior Myocardial Infarction Treated With Primary Percutaneous Intervention. Front Cardiovasc Med. 2022 Jul 27;9:922567. doi: 10.3389/fcvm.2022.922567. eCollection 2022.'}]}, 'descriptionModule': {'briefSummary': 'The study intends to investigate the alteration of regional myocardial work in patients with acute anterior myocardial infarction underwent primary percutaneous coronary intervention (PCI), and compare the distribution of regional myocardial work in patients with/without early remodeling at acute phase and 3-month follow-up.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with anterior STEMI who underwent primary PCI \\<12 hours after symptom onset were consecutive enrolled in our center.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Anterior myocardial infarct (anterior myocardial infarct is defined as persistent chest pain for 30 mins at least, with ST-segment elevation of at least 0.2 mV in two or more contiguous precordial leads) within 12 hours after onsets of symptom;\n* Left anterior descending (LAD) as culprit vessel, with TIMI 0-1 grade.\n\nExclusion Criteria:\n\n* significant valvular disease;\n* cardiomyopathy; l\n* left bundle branch block;\n* atrial fibrillation;\n* previous myocardial infarction (MI);\n* history of cardiac surgery;\n* pacemaker implantation.'}, 'identificationModule': {'nctId': 'NCT05107102', 'briefTitle': 'Myocardial Work for Prediction of Left Ventricular Remodeling in Patients With STEMI', 'organization': {'class': 'OTHER', 'fullName': 'RenJi Hospital'}, 'officialTitle': 'Value of Myocardial Work for Prediction of Left Ventricular Remodeling in Patients With ST-Elevation Myocardial Infarction Treated by Primary Percutaneous Intervention', 'orgStudyIdInfo': {'id': 'STEMI-myocardial work'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'patients with LVR(left ventricular remodeling)'}, {'label': 'patients without LVR(left ventricular remodeling)'}]}, 'contactsLocationsModule': {'locations': [{'zip': '200125', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'Song Ding, MD,PHD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'RenJi Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}