Ignite Creation Date:
2025-12-24 @ 9:30 PM
Ignite Modification Date:
2026-03-03 @ 6:05 PM
Study NCT ID:
NCT06759532
Status:
COMPLETED
Last Update Posted:
2025-01-06
First Post:
2024-12-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Persistent Microvascular Obstruction by Cardiac Magnetic Resonance on Prognosis for ST-segment Elevation Myocardial Infarction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000072657', 'term': 'ST Elevation Myocardial Infarction'}, {'id': 'D009203', 'term': 'Myocardial Infarction'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009336', 'term': 'Necrosis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 344}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2024-10-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-30', 'studyFirstSubmitDate': '2024-12-30', 'studyFirstSubmitQcDate': '2024-12-30', 'lastUpdatePostDateStruct': {'date': '2025-01-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Main aderverse cardiac events', 'timeFrame': '5 years after myocardiac infarction', 'description': 'Composite endpoint of all-cause death, readmission due to heart failure, recurrent myocardial infarction, and unexpected vascularization.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Microvascular occlusion;', 'ST-segment elevation myocardial infarction', 'Prognosis'], 'conditions': ['ST Elevation (STEMI) Myocardial Infarction']}, 'referencesModule': {'references': [{'pmid': '28823746', 'type': 'BACKGROUND', 'citation': 'Symons R, Pontone G, Schwitter J, Francone M, Iglesias JF, Barison A, Zalewski J, de Luca L, Degrauwe S, Claus P, Guglielmo M, Nessler J, Carbone I, Ferro G, Durak M, Magistrelli P, Lo Presti A, Aquaro GD, Eeckhout E, Roguelov C, Andreini D, Vogt P, Guaricci AI, Mushtaq S, Lorenzoni V, Muller O, Desmet W, Agati L, Janssens S, Bogaert J, Masci PG. Long-Term Incremental Prognostic Value of Cardiovascular Magnetic Resonance After ST-Segment Elevation Myocardial Infarction: A Study of the Collaborative Registry on CMR in STEMI. JACC Cardiovasc Imaging. 2018 Jun;11(6):813-825. doi: 10.1016/j.jcmg.2017.05.023. Epub 2017 Aug 16.'}, {'pmid': '37052556', 'type': 'BACKGROUND', 'citation': 'Bodi V, Gavara J, Lopez-Lereu MP, Monmeneu JV, de Dios E, Perez-Sole N, Bonanad C, Marcos-Garces V, Canoves J, Minana G, Nunez J, Moratal D, Chorro FJ, Rodriguez-Palomares JF, Freixa A, Borras R, Ortiz-Perez JT, Rios-Navarro C. Impact of Persistent Microvascular Obstruction Late After STEMI on Adverse LV Remodeling: A CMR Study. JACC Cardiovasc Imaging. 2023 Jul;16(7):919-930. doi: 10.1016/j.jcmg.2023.01.021. Epub 2023 Apr 12.'}, {'pmid': '38777509', 'type': 'BACKGROUND', 'citation': 'Lechner I, Reindl M, Stiermaier T, Tiller C, Holzknecht M, Oberhollenzer F, von der Emde S, Mayr A, Feistritzer HJ, Carberry J, Carrick D, Bauer A, Thiele H, Berry C, Eitel I, Metzler B, Reinstadler SJ. Clinical Outcomes Associated With Various Microvascular Injury Patterns Identified by CMR After STEMI. J Am Coll Cardiol. 2024 May 28;83(21):2052-2062. doi: 10.1016/j.jacc.2024.03.408.'}, {'pmid': '19502624', 'type': 'BACKGROUND', 'citation': 'Orn S, Manhenke C, Greve OJ, Larsen AI, Bonarjee VV, Edvardsen T, Dickstein K. Microvascular obstruction is a major determinant of infarct healing and subsequent left ventricular remodelling following primary percutaneous coronary intervention. Eur Heart J. 2009 Aug;30(16):1978-85. doi: 10.1093/eurheartj/ehp219. Epub 2009 Jun 6.'}, {'pmid': '16803939', 'type': 'BACKGROUND', 'citation': 'Bodi V, Sanchis J, Lopez-Lereu MP, Nunez J, Sanz R, Palau P, Gomez C, Moratal D, Chorro FJ, Llacer A. Microvascular perfusion 1 week and 6 months after myocardial infarction by first-pass perfusion cardiovascular magnetic resonance imaging. Heart. 2006 Dec;92(12):1801-7. doi: 10.1136/hrt.2005.077305. Epub 2006 Jun 27.'}, {'pmid': '20348438', 'type': 'BACKGROUND', 'citation': 'Weir RA, Murphy CA, Petrie CJ, Martin TN, Balmain S, Clements S, Steedman T, Wagner GS, Dargie HJ, McMurray JJ. Microvascular obstruction remains a portent of adverse remodeling in optimally treated patients with left ventricular systolic dysfunction after acute myocardial infarction. Circ Cardiovasc Imaging. 2010 Jul;3(4):360-7. doi: 10.1161/CIRCIMAGING.109.897439. Epub 2010 Mar 26.'}, {'pmid': '25212799', 'type': 'BACKGROUND', 'citation': 'van Kranenburg M, Magro M, Thiele H, de Waha S, Eitel I, Cochet A, Cottin Y, Atar D, Buser P, Wu E, Lee D, Bodi V, Klug G, Metzler B, Delewi R, Bernhardt P, Rottbauer W, Boersma E, Zijlstra F, van Geuns RJ. Prognostic value of microvascular obstruction and infarct size, as measured by CMR in STEMI patients. JACC Cardiovasc Imaging. 2014 Sep;7(9):930-9. doi: 10.1016/j.jcmg.2014.05.010.'}, {'pmid': '31661823', 'type': 'BACKGROUND', 'citation': 'Rios-Navarro C, Marcos-Garces V, Bayes-Genis A, Husser O, Nunez J, Bodi V. Microvascular Obstruction in ST-Segment Elevation Myocardial Infarction: Looking Back to Move Forward. Focus on CMR. J Clin Med. 2019 Oct 28;8(11):1805. doi: 10.3390/jcm8111805.'}]}, 'descriptionModule': {'briefSummary': 'The aims of the study were to evaluate the predictive value of persistent microvascular obstruction (MVO) by cardiac magnetic resonance for main adverse cardiac events in ST-segment elevation myocardial infarction patients.\n\nMVO in the acute phase of myocardial infarction has been considered to be strong predictor of a poor prognosis. We plan to explore the relationship between persistent MVO and the long-term prognosis of patients with STEMI. We made hypothesis that patients with persistent MVO have a poor prognosis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The patients in this study were diagnosis as STEMI, and were plan to undergo primary percutaneous coronary intervention and were plan to underwent cardiac magnetic resonance at 7 days and 6 months after primary percutaneous coronary intervention . The patients were divided into three groups according to the presence of absence of MVO at the first cardiac magnetic resonance and second cardiac magnetic resonance.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ST-segment elevation myocardial infarction undewent primary percutaneous coronary intervention\n\nExclusion Criteria:\n\n* contraindications for cardiac magnetic resonance\n* severe heart failure\n* previous myocardial infarction.'}, 'identificationModule': {'nctId': 'NCT06759532', 'acronym': 'IMCOME', 'briefTitle': 'Impact of Persistent Microvascular Obstruction by Cardiac Magnetic Resonance on Prognosis for ST-segment Elevation Myocardial Infarction', 'organization': {'class': 'OTHER', 'fullName': 'Chinese PLA General Hospital'}, 'officialTitle': 'Prognostic Role of Persistent Microvascular Obstruction by Cardiac Magnetic Resonance for ST-segment Elevation Myocardial Infarction', 'orgStudyIdInfo': {'id': 'Persistent MVO on prognosis'}, 'secondaryIdInfos': [{'id': 'Z-2017-26-2202-2', 'type': 'OTHER_GRANT', 'domain': 'China international medical fundation'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Without MVO group', 'description': 'STEMI patients without MVO both in the acutephase and chronic phase of myocardial inarction'}, {'label': 'with transient MVO group', 'description': 'STEMI patients with MVO only in the acutephase of myocardial inarction'}, {'label': 'with persietent MVO group', 'description': 'STEMI patients without MVO both in the acutephase and chronic phase of myocardial inarction'}]}, 'contactsLocationsModule': {'locations': [{'zip': '10086', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Chinese PLA general hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese PLA General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Qian geng', 'investigatorAffiliation': 'Chinese PLA General Hospital'}}}}