Ignite Creation Date:
2025-12-24 @ 5:41 PM
Ignite Modification Date:
2025-12-29 @ 8:01 AM
Study NCT ID:
NCT04157868
Status:
UNKNOWN
Last Update Posted:
2019-11-08
First Post:
2019-11-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Early rhBNP on Myocardial Work in Patients With STEMI
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2019-11-30', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2022-11-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-11-06', 'studyFirstSubmitDate': '2019-11-05', 'studyFirstSubmitQcDate': '2019-11-06', 'lastUpdatePostDateStruct': {'date': '2019-11-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-11-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Global myocardial work efficiency by echocardiography', 'timeFrame': '30 days after PCI', 'description': 'Echocardial myocardial work (MW) may identify early abnormalities in left ventricular(LV) function and may establish a more sensitive index for early stage LV dysfunction.Global MW was quantified by calculating the rate of regional shortening by differentiation of the strain tracing and multiplying by instantaneous LV pressure. This instantaneous measure of power was this integrated over time to measure MW as a function of time during systole (time interval from mitral valve closure through to mitral valve opening). During LV ejection, segments were analyzed for wasted work (WW) and/or constructive work (CW), with global values determined as the averages of all segmental values and displayed on the LV pressure-strain loop diagram.\n\nGlobal myocardial work efficiency (GWE; %), constructive MW divided by the sum of CW and WW, expressed as a percentage.'}], 'secondaryOutcomes': [{'measure': 'Global myocardial work index by echocardiography', 'timeFrame': 'Day 1, 7, 30 after PCI', 'description': 'Global myocardial work index (GWI): total work within the area of the LV PSL calculated frommitral valve closure to mitral valve opening.'}, {'measure': 'Global myocardial constructive work by echocardiography', 'timeFrame': 'Day 1, 7, 30 after PCI', 'description': 'Global myocardial constructive work (mm Hg %), an estimate of the work performed by the LV segments consisting of shortening during systole plus lengthening in isovolumic relaxation.'}, {'measure': 'Global myocardial waste work by echocardiography', 'timeFrame': 'Day 1, 7, 30 after PCI', 'description': 'Global myocardial waste work (mm Hg %), an estimate of negative work of the LV segments consisting of myocardial lengthening during systole plus any shortening during isovolumic relaxation.'}, {'measure': 'Clinical Outcomes', 'timeFrame': '30 days after PCI', 'description': 'Compound endpoints of all cause death, non-fatal reinfarction, heart failure, and stroke;'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ST-Segment Elevated Myocardial Infarction', 'rhBNP', 'non-invasive myocardial work'], 'conditions': ['ST-Segment Elevated Myocardial Infarction']}, 'referencesModule': {'references': [{'pmid': '21712046', 'type': 'BACKGROUND', 'citation': 'Schwartz BG, Kloner RA. Coronary no reflow. J Mol Cell Cardiol. 2012 Apr;52(4):873-82. doi: 10.1016/j.yjmcc.2011.06.009. Epub 2011 Jun 21.'}, {'pmid': '19608025', 'type': 'BACKGROUND', 'citation': 'Niccoli G, Burzotta F, Galiuto L, Crea F. Myocardial no-reflow in humans. J Am Coll Cardiol. 2009 Jul 21;54(4):281-92. doi: 10.1016/j.jacc.2009.03.054.'}, {'pmid': '24352519', 'type': 'BACKGROUND', 'citation': 'Go AS, Mozaffarian D, Roger VL, Benjamin EJ, Berry JD, Blaha MJ, Dai S, Ford ES, Fox CS, Franco S, Fullerton HJ, Gillespie C, Hailpern SM, Heit JA, Howard VJ, Huffman MD, Judd SE, Kissela BM, Kittner SJ, Lackland DT, Lichtman JH, Lisabeth LD, Mackey RH, Magid DJ, Marcus GM, Marelli A, Matchar DB, McGuire DK, Mohler ER 3rd, Moy CS, Mussolino ME, Neumar RW, Nichol G, Pandey DK, Paynter NP, Reeves MJ, Sorlie PD, Stein J, Towfighi A, Turan TN, Virani SS, Wong ND, Woo D, Turner MB; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics--2014 update: a report from the American Heart Association. Circulation. 2014 Jan 21;129(3):e28-e292. doi: 10.1161/01.cir.0000441139.02102.80. Epub 2013 Dec 18. No abstract available.'}, {'pmid': '21173361', 'type': 'BACKGROUND', 'citation': 'Kehat I, Molkentin JD. Molecular pathways underlying cardiac remodeling during pathophysiological stimulation. Circulation. 2010 Dec 21;122(25):2727-35. doi: 10.1161/CIRCULATIONAHA.110.942268. No abstract available.'}, {'pmid': '25893101', 'type': 'BACKGROUND', 'citation': "Postma S, Dambrink JH, Gosselink AT, Ottervanger JP, Kolkman E, Ten Berg JM, Suryapranata H, van 't Hof AW. The influence of system delay on 30-day and on long-term mortality in patients with anterior versus non-anterior ST-segment elevation myocardial infarction: a cohort study. Open Heart. 2015 Apr 10;2(1):e000201. doi: 10.1136/openhrt-2014-000201. eCollection 2015."}, {'pmid': '18252972', 'type': 'BACKGROUND', 'citation': 'Wu GF, Wykrzykowska JJ, Rana JS, Pinto DS, Gibson CM, Li J, Sellke FW, Laham RJ. Effects of B-type natriuretic peptide (nesiritide) on coronary epicardial arteries, systemic vasculature and microvessels. J Invasive Cardiol. 2008 Feb;20(2):76-80.'}, {'pmid': '19356529', 'type': 'BACKGROUND', 'citation': 'Sjoli B, Orn S, Grenne B, Ihlen H, Edvardsen T, Brunvand H. Diagnostic capability and reproducibility of strain by Doppler and by speckle tracking in patients with acute myocardial infarction. JACC Cardiovasc Imaging. 2009 Jan;2(1):24-33. doi: 10.1016/j.jcmg.2008.10.007.'}, {'pmid': '21511433', 'type': 'BACKGROUND', 'citation': 'Shimoni S, Gendelman G, Ayzenberg O, Smirin N, Lysyansky P, Edri O, Deutsch L, Caspi A, Friedman Z. Differential effects of coronary artery stenosis on myocardial function: the value of myocardial strain analysis for the detection of coronary artery disease. J Am Soc Echocardiogr. 2011 Jul;24(7):748-57. doi: 10.1016/j.echo.2011.03.007. Epub 2011 Apr 20.'}, {'pmid': '29529181', 'type': 'BACKGROUND', 'citation': 'Hubert A, Le Rolle V, Leclercq C, Galli E, Samset E, Casset C, Mabo P, Hernandez A, Donal E. Estimation of myocardial work from pressure-strain loops analysis: an experimental evaluation. Eur Heart J Cardiovasc Imaging. 2018 Dec 1;19(12):1372-1379. doi: 10.1093/ehjci/jey024.'}, {'pmid': '19666722', 'type': 'BACKGROUND', 'citation': 'Donal E, Bergerot C, Thibault H, Ernande L, Loufoua J, Augeul L, Ovize M, Derumeaux G. Influence of afterload on left ventricular radial and longitudinal systolic functions: a two-dimensional strain imaging study. Eur J Echocardiogr. 2009 Dec;10(8):914-21. doi: 10.1093/ejechocard/jep095. Epub 2009 Aug 7.'}, {'pmid': '31043359', 'type': 'BACKGROUND', 'citation': 'Edwards NFA, Scalia GM, Shiino K, Sabapathy S, Anderson B, Chamberlain R, Khandheria BK, Chan J. Global Myocardial Work Is Superior to Global Longitudinal Strain to Predict Significant Coronary Artery Disease in Patients With Normal Left Ventricular Function and Wall Motion. J Am Soc Echocardiogr. 2019 Aug;32(8):947-957. doi: 10.1016/j.echo.2019.02.014. Epub 2019 Apr 28.'}, {'pmid': '20463209', 'type': 'BACKGROUND', 'citation': "Masci PG, Marinelli M, Piacenti M, Lorenzoni V, Positano V, Lombardi M, L'Abbate A, Neglia D. Myocardial structural, perfusion, and metabolic correlates of left bundle branch block mechanical derangement in patients with dilated cardiomyopathy: a tagged cardiac magnetic resonance and positron emission tomography study. Circ Cardiovasc Imaging. 2010 Jul;3(4):482-90. doi: 10.1161/CIRCIMAGING.109.934638. Epub 2010 May 12."}, {'pmid': '31023060', 'type': 'BACKGROUND', 'citation': 'Duchenne J, Turco A, Unlu S, Pagourelias ED, Vunckx K, Degtiarova G, Bezy S, Cvijic M, Nuyts J, Claus P, Rega F, Gheysens O, Voigt JU. Left Ventricular Remodeling Results in Homogenization of Myocardial Work Distribution. Circ Arrhythm Electrophysiol. 2019 May;12(5):e007224. doi: 10.1161/CIRCEP.118.007224.'}, {'pmid': '25851329', 'type': 'BACKGROUND', 'citation': 'Boe E, Russell K, Eek C, Eriksen M, Remme EW, Smiseth OA, Skulstad H. Non-invasive myocardial work index identifies acute coronary occlusion in patients with non-ST-segment elevation-acute coronary syndrome. Eur Heart J Cardiovasc Imaging. 2015 Nov;16(11):1247-55. doi: 10.1093/ehjci/jev078. Epub 2015 Apr 6.'}]}, 'descriptionModule': {'briefSummary': 'The study intends to evaluate the efficacy of early rhBNP on myocardial work in patients with anterior ST-segment elevation myocardial infarction after percutaneous coronary intervention'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1\\. 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\n 2\\. No contraindication for rhBNP;\n\n 3\\. Left anterior descending (LAD) as culprit vessel, with TIMI 0-1 grade.\n\nExclusion Criteria:\n\n* 1.Cardiogenic shock (systolic BP \\<90mmHg after fluid infusion or systolic BP\\<100mmHg after vasoactive drugs);\n\n 2\\. History of myocardial infarct;\n\n 3.Severe arrhythmia: with III degree A-V block ,atrial fibrillation,ventricular fibrillation,ventricular tachycardia;\n\n 4\\. Any history of severe renal or hepatic dysfunction (hepatic failure, cirrhosis, portal hypertension or active hepatitis); neutropenia or thrombocytopenia; known acute pancreatitis;\n\n 5\\. Pregnant or lactating;\n\n 6\\. life expectancy≤12 months;\n\n 7\\. Inability to follow the protocol and comply with follow-up requirements or any other reason the investigator feels would place the patient at increased risk;'}, 'identificationModule': {'nctId': 'NCT04157868', 'briefTitle': 'Early rhBNP on Myocardial Work in Patients With STEMI', 'organization': {'class': 'OTHER', 'fullName': 'RenJi Hospital'}, 'officialTitle': 'The Impact of Early rhBNP on Myocardial Work in Patients With Anterior ST-segment Elevation Myocardial Infarction After Percutaneous Coronary Intervention', 'orgStudyIdInfo': {'id': 'EARLY MYO-myocardial work'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'rhBNP', 'description': 'rhBNP intra-coronary injection 1.5 ug/kg loading dose, with intravenous injection 0.0075-0.01 ug/kg/min persistent for 72 hour.', 'interventionNames': ['Drug: rhBNP']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'description': 'Saline intra-coronary injection 0.15ml/kg loading dose, with same intravenous injection speed for 72 hour after randomization.', 'interventionNames': ['Drug: Control']}], 'interventions': [{'name': 'rhBNP', 'type': 'DRUG', 'description': 'rhBNP intra-coronary injection 1.5 ug/kg loading dose, with intravenous injection 0.0075-0.01 ug/kg/min persistent for 72 hour.', 'armGroupLabels': ['rhBNP']}, {'name': 'Control', 'type': 'DRUG', 'description': 'Saline intra-coronary injection 0.15ml/kg loading dose, with same intravenous injection speed for 72 hour.', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Song Ding, MD,Ph.D.', 'role': 'CONTACT', 'email': 'dingsong1105@163.com', 'phone': '86-21-68383477'}], 'overallOfficials': [{'name': 'Song Ding, MD,Ph.D.', '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'}}}}