Ignite Creation Date:
2025-12-24 @ 6:37 PM
Ignite Modification Date:
2026-01-21 @ 5:10 AM
Study NCT ID:
NCT05348057
Status:
UNKNOWN
Last Update Posted:
2022-04-27
First Post:
2021-12-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Study of CMR to Evaluate the Effect of Ivabradine on the Improvement of Left Ventricular Remodeling in STEMI Patients After Primary PCI
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077550', 'term': 'Ivabradine'}], 'ancestors': [{'id': 'D001552', 'term': 'Benzazepines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 240}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2022-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-04-21', 'studyFirstSubmitDate': '2021-12-05', 'studyFirstSubmitQcDate': '2022-04-21', 'lastUpdatePostDateStruct': {'date': '2022-04-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Myocardial infarct size according to MR delayed enhancement scan', 'timeFrame': '7 days after PCI', 'description': 'Two experienced MRI cardiologists analyzed the delayed enhancement image enhancement area of MRI to obtain the area of myocardial infarction through the Segment v1.9 post-processing software'}, {'measure': 'main cardiovascular events', 'timeFrame': 'follow up in 6 months', 'description': 'Acute heart failure, recurrence of myocardial infarction, death from all causes, stroke, cardiac death, recurrent myocardial infarction, recurrent target vascular revascularization, re-admission because of angina pectoris or heart failure'}], 'secondaryOutcomes': [{'measure': 'change of the LVEF', 'timeFrame': 'follow up in 6 months', 'description': 'left ventricular ejection fraction (LVEF)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cardiovascular Diseases']}, 'referencesModule': {'references': [{'pmid': '19147457', 'type': 'BACKGROUND', 'citation': 'Logeart D, Gueffet JP, Rouzet F, Pousset F, Chavelas C, Solal AC, Jondeau G. Heart rate per se impacts cardiac function in patients with systolic heart failure and pacing: a pilot study. Eur J Heart Fail. 2009 Jan;11(1):53-7. doi: 10.1093/eurjhf/hfn016.'}, {'pmid': '18486549', 'type': 'BACKGROUND', 'citation': 'De Ferrari GM, Mazzuero A, Agnesina L, Bertoletti A, Lettino M, Campana C, Schwartz PJ, Tavazzi L. Favourable effects of heart rate reduction with intravenous administration of ivabradine in patients with advanced heart failure. Eur J Heart Fail. 2008 Jun;10(6):550-5. doi: 10.1016/j.ejheart.2008.04.005. Epub 2008 May 16.'}, {'pmid': '16433867', 'type': 'BACKGROUND', 'citation': 'Joannides R, Moore N, Iacob M, Compagnon P, Lerebours G, Menard JF, Thuillez C. Comparative effects of ivabradine, a selective heart rate-lowering agent, and propranolol on systemic and cardiac haemodynamics at rest and during exercise. Br J Clin Pharmacol. 2006 Feb;61(2):127-37. doi: 10.1111/j.1365-2125.2005.02544.x.'}, {'pmid': '21875859', 'type': 'BACKGROUND', 'citation': 'Ekman I, Chassany O, Komajda M, Bohm M, Borer JS, Ford I, Tavazzi L, Swedberg K. Heart rate reduction with ivabradine and health related quality of life in patients with chronic heart failure: results from the SHIFT study. Eur Heart J. 2011 Oct;32(19):2395-404. doi: 10.1093/eurheartj/ehr343. Epub 2011 Aug 29.'}, {'pmid': '21875858', 'type': 'BACKGROUND', 'citation': "Tardif JC, O'Meara E, Komajda M, Bohm M, Borer JS, Ford I, Tavazzi L, Swedberg K; SHIFT Investigators. Effects of selective heart rate reduction with ivabradine on left ventricular remodelling and function: results from the SHIFT echocardiography substudy. Eur Heart J. 2011 Oct;32(20):2507-15. doi: 10.1093/eurheartj/ehr311. Epub 2011 Aug 29."}, {'pmid': '22927555', 'type': 'BACKGROUND', 'citation': 'Borer JS, Bohm M, Ford I, Komajda M, Tavazzi L, Sendon JL, Alings M, Lopez-de-Sa E, Swedberg K; SHIFT Investigators. Effect of ivabradine on recurrent hospitalization for worsening heart failure in patients with chronic systolic heart failure: the SHIFT Study. Eur Heart J. 2012 Nov;33(22):2813-20. doi: 10.1093/eurheartj/ehs259. Epub 2012 Aug 27.'}, {'pmid': '24332674', 'type': 'BACKGROUND', 'citation': 'Borer JS, Bohm M, Ford I, Robertson M, Komajda M, Tavazzi L, Swedberg K; SHIFT Investigators. Efficacy and safety of ivabradine in patients with severe chronic systolic heart failure (from the SHIFT study). Am J Cardiol. 2014 Feb 1;113(3):497-503. doi: 10.1016/j.amjcard.2013.10.033. Epub 2013 Nov 9.'}, {'pmid': '27167103', 'type': 'BACKGROUND', 'citation': 'Hidalgo FJ, Anguita M, Castillo JC, Rodriguez S, Pardo L, Duran E, Sanchez JJ, Ferreiro C, Pan M, Mesa D, Delgado M, Ruiz M. Effect of early treatment with ivabradine combined with beta-blockers versus beta-blockers alone in patients hospitalised with heart failure and reduced left ventricular ejection fraction (ETHIC-AHF): A randomised study. Int J Cardiol. 2016 Aug 15;217:7-11. doi: 10.1016/j.ijcard.2016.04.136. Epub 2016 Apr 19.'}, {'pmid': '27594127', 'type': 'BACKGROUND', 'citation': 'Sisakian H, Sargsyan T, Khachatryan A. Effect of selective heart rate reduction through sinus node If current inhibition on severely impaired left ventricular diastolic dysfunction in patients with chronic heart failure. Acta Cardiol. 2016 Jun;71(3):317-22. doi: 10.2143/AC.71.3.3152092. No abstract available.'}, {'pmid': '22617188', 'type': 'BACKGROUND', 'citation': 'Swedberg K, Komajda M, Bohm M, Borer J, Robertson M, Tavazzi L, Ford I; SHIFT Investigators. Effects on outcomes of heart rate reduction by ivabradine in patients with congestive heart failure: is there an influence of beta-blocker dose?: findings from the SHIFT (Systolic Heart failure treatment with the I(f) inhibitor ivabradine Trial) study. J Am Coll Cardiol. 2012 May 29;59(22):1938-45. doi: 10.1016/j.jacc.2012.01.020.'}]}, 'descriptionModule': {'briefSummary': 'This study aim to investigate the effect of ivabradine on reducing infarct size and improving left ventricular remodeling after in patients undergoing primary PCI for ST-elevation myocardial infarction through myocardial enhanced MRI.', 'detailedDescription': 'Investigators will enroll 240 patients with STEMI who were admitted to the Chinese PLA General Hospital between October 2020 and October 2021，the investigators randomly assign eligible patients in a 1:1 ratio to either ivabradine or oral placebo befor primary PCI. The treatment was initiated after primary PCI with ivabradine orally for 6 months. Primary end point of the study was the area of infarct size measured by cardiac magnetic resonance (CMR). Cardiovascular events concluding stroke, repeat revascularization, rehospitalization for acute heart failure, nonfatal myocardial infarction, and all cause death. All adverse clinical events as well as study end points were monitored and adjudicated by the independent event committee.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* STEMI patients: typical chest pain lasting 30 min within the previous 12 h, a clear ST-segment elevation of N0.1 mV in ≥2 contiguous electrocardiographic leads, and elevated blood levels of troponin T\n* patients were scheduled to undergo diagnostic cardiac angiography or percutaneous coronary interventions\n\nExclusion Criteria:\n\n* had once treated by ivabradine\n* history of myocardial infarction\n* mechanical complications\n* Unable to perform myocardial MRI\n* liver and kidney failure\n* malignant tumor\n* unconscious'}, 'identificationModule': {'nctId': 'NCT05348057', 'briefTitle': 'Clinical Study of CMR to Evaluate the Effect of Ivabradine on the Improvement of Left Ventricular Remodeling in STEMI Patients After Primary PCI', 'organization': {'class': 'OTHER', 'fullName': 'Chinese PLA General Hospital'}, 'officialTitle': 'Clinical Study of CMR to Evaluate the Effect of Ivabradine on the Improvement of Left Ventricular Remodeling in STEMI Patients After Primary PCI', 'orgStudyIdInfo': {'id': 'qg-2021-12-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ivabradine group', 'description': "The starting dose is 5 mg twice a day. After 2 weeks of treatment, if the patient's resting heart rate continues to be higher than 70 beats per minute, increase the dose to 7.5 mg twice a day. If the patient's resting heart rate continues to be less than 50 beats per minute or symptoms related to bradycardia occur, reduce the dose to 2.5 mg", 'interventionNames': ['Drug: Ivabradine']}, {'type': 'NO_INTERVENTION', 'label': 'The control group'}], 'interventions': [{'name': 'Ivabradine', 'type': 'DRUG', 'description': 'The starting dose is 5 mg twice a day. Adjust the dose according to the actual situation', 'armGroupLabels': ['Ivabradine group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100853', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Geng Qian, MD', 'role': 'CONTACT', 'email': 'qiangeng9396@263.net', 'phone': '086-01055499312'}, {'name': 'Yun-dai Chen, MD', 'role': 'CONTACT', 'email': 'cyundai@126.com', 'phone': '086-01055499309'}], 'facility': "Chinese People's Liberation Army General Hospital", 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Qian geng', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'Qian geng', 'investigatorAffiliation': 'Chinese PLA General Hospital'}}}}