Ignite Creation Date:
2025-12-25 @ 1:43 AM
Ignite Modification Date:
2025-12-26 @ 12:01 AM
Study NCT ID:
NCT05346094
Status:
RECRUITING
Last Update Posted:
2023-01-04
First Post:
2021-08-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cardiac Normal Values Assessed by Magnetic Resonance Imaging
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Blood sample'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 938}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2027-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-01-03', 'studyFirstSubmitDate': '2021-08-02', 'studyFirstSubmitQcDate': '2022-04-20', 'lastUpdatePostDateStruct': {'date': '2023-01-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Normal values of left and right structures and cardiac function', 'timeFrame': '5 years', 'description': 'Create a database for normal values of left and right structures and cardiac function'}, {'measure': 'Normal values of novel cardiovascular magnetic resonance parameters', 'timeFrame': '5 years', 'description': 'Create a database for normal values of novel cardiovascular magnetic resonance parameters'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['reference values', 'morphology', 'function', 'tissue characterization', 'myocardial deformation', 'cardiocascular magnetic resonance imaging'], 'conditions': ['Healthy Participants', 'Reference Values']}, 'referencesModule': {'references': [{'pmid': '28942735', 'type': 'RESULT', 'citation': 'von Knobelsdorff-Brenkenhoff F, Pilz G, Schulz-Menger J. Representation of cardiovascular magnetic resonance in the AHA / ACC guidelines. J Cardiovasc Magn Reson. 2017 Sep 25;19(1):70. doi: 10.1186/s12968-017-0385-z.'}, {'pmid': '26800662', 'type': 'RESULT', 'citation': 'von Knobelsdorff-Brenkenhoff F, Schulz-Menger J. Role of cardiovascular magnetic resonance in the guidelines of the European Society of Cardiology. J Cardiovasc Magn Reson. 2016 Jan 22;18:6. doi: 10.1186/s12968-016-0225-6.'}, {'pmid': '32394180', 'type': 'RESULT', 'citation': 'Zhou D, Xu J, Zhao S, Lu M. CMR publications from China of the last more than 30 years. Int J Cardiovasc Imaging. 2020 Sep;36(9):1737-1747. doi: 10.1007/s10554-020-01873-x. Epub 2020 May 11.'}, {'pmid': '23331632', 'type': 'RESULT', 'citation': 'Bruder O, Wagner A, Lombardi M, Schwitter J, van Rossum A, Pilz G, Nothnagel D, Steen H, Petersen S, Nagel E, Prasad S, Schumm J, Greulich S, Cagnolo A, Monney P, Deluigi CC, Dill T, Frank H, Sabin G, Schneider S, Mahrholdt H. European Cardiovascular Magnetic Resonance (EuroCMR) registry--multi national results from 57 centers in 15 countries. J Cardiovasc Magn Reson. 2013 Jan 18;15(1):9. doi: 10.1186/1532-429X-15-9.'}, {'pmid': '23787094', 'type': 'RESULT', 'citation': 'Klinke V, Muzzarelli S, Lauriers N, Locca D, Vincenti G, Monney P, Lu C, Nothnagel D, Pilz G, Lombardi M, van Rossum AC, Wagner A, Bruder O, Mahrholdt H, Schwitter J. Quality assessment of cardiovascular magnetic resonance in the setting of the European CMR registry: description and validation of standardized criteria. J Cardiovasc Magn Reson. 2013 Jun 20;15(1):55. doi: 10.1186/1532-429X-15-55.'}, {'pmid': '22093267', 'type': 'RESULT', 'citation': 'Bruder O, Schneider S, Nothnagel D, Pilz G, Lombardi M, Sinha A, Wagner A, Dill T, Frank H, van Rossum A, Schwitter J, Nagel E, Senges J, Sabin G, Sechtem U, Mahrholdt H. Acute adverse reactions to gadolinium-based contrast agents in CMR: multicenter experience with 17,767 patients from the EuroCMR Registry. JACC Cardiovasc Imaging. 2011 Nov;4(11):1171-6. doi: 10.1016/j.jcmg.2011.06.019.'}, {'pmid': '28187739', 'type': 'RESULT', 'citation': 'Global Cardiovascular Magnetic Resonance Registry (GCMR) Investigators; Kwong RY, Petersen SE, Schulz-Menger J, Arai AE, Bingham SE, Chen Y, Choi YL, Cury RC, Ferreira VM, Flamm SD, Steel K, Bandettini WP, Martin ET, Nallamshetty L, Neubauer S, Raman SV, Schelbert EB, Valeti US, Cao JJ, Reichek N, Young AA, Fexon L, Pivovarov M, Ferrari VA, Simonetti OP. The global cardiovascular magnetic resonance registry (GCMR) of the society for cardiovascular magnetic resonance (SCMR): its goals, rationale, data infrastructure, and current developments. J Cardiovasc Magn Reson. 2017 Jan 20;19(1):23. doi: 10.1186/s12968-016-0321-7.'}, {'pmid': '32964326', 'type': 'RESULT', 'citation': 'Esposito A, Gallone G, Palmisano A, Marchitelli L, Catapano F, Francone M. The current landscape of imaging recommendations in cardiovascular clinical guidelines: toward an imaging-guided precision medicine. Radiol Med. 2020 Nov;125(11):1013-1023. doi: 10.1007/s11547-020-01286-9. Epub 2020 Sep 22.'}]}, 'descriptionModule': {'briefSummary': 'This study carried out a study enrolled healthy volunteers to comprehensively provide age and sex specific reference values of the normal cardiac structure and function of Chinese adults, using the steady-state free precession technique (SSFP) as well as reference values for novel cardiovascular magnetic resonance techniques including myocardial strian and tissue characterization.', 'detailedDescription': 'Cardiovascular magnetic resonance (CMR), as a non-invasive and radiation-free examination, can identify the structural and functional abnormalities of various cardiovascular diseases. It is the gold standard for cardiovascular structural and functional measurements, and recommended as a priority examination for cardiovascular diseases by guidelines of the American College of Cardiology (ACC/AHA) and the European College of Cardiology (ESC). The reference standard for cardiovascular structure and function of normal people is the basis for cardiovascular disease study, and plays a vital role in diagnosis, differential diagnosis, and prognosis evaluation. CMR parameters have been shown to provide significant information for the general population and have always been important biomarkers for morbidity and mortality in patients with cardiac pathologies. Although there are relevant reference standards for normal values in the world, there is no standard for normal values of large samples of Chinese people. In addition, most of the normal values are limited to traditional parameters of cardiac structure and function, and there is no normal value standard for novel parameters including myocardial strain and tissue characteristics. Therefore, on the basis of previous works, our group planned to create a cardiovascular MRI reference value database of normal Chinese people through retrospective and prospective recruitment, which will lay a foundation for the early identification and prognosis assessment of cardiovascular diseases, and promote the progress of systematic cardiovascular magnetic resonance studies.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Healthy subjects without cardiovascular disease, cardiovascular related symptoms and risk factors judged by combining clinical manifestations, non-invasive imaging and laboratory examination', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nSubjects without cardiovascular disease, cardiovascular related symptoms and risk factors judged by combining clinical manifestations, non-invasive imaging and laboratory examination\n\nExclusion Criteria:\n\n* Subjects clinically screened or previously diagnosed with cardiovascular disease and risk factors\n* Subjects with serious non-cardiovascular diseases\n* Subjects with poor quality of magnetic resonance imaging\n* Subjects refused to participate in the study\n* Subjects with contraindications to MRI'}, 'identificationModule': {'nctId': 'NCT05346094', 'briefTitle': 'Cardiac Normal Values Assessed by Magnetic Resonance Imaging', 'organization': {'class': 'OTHER', 'fullName': 'Chinese Academy of Medical Sciences, Fuwai Hospital'}, 'officialTitle': 'A Multicenter Investigation of Cardiac Normal Values of Morphology, Function and Tissue Characteristics by Magnetic Resonance Imaging', 'orgStudyIdInfo': {'id': 'CMR_Normal'}}, 'armsInterventionsModule': {'interventions': [{'name': 'No intervention', 'type': 'OTHER', 'description': 'No intervention'}]}, 'contactsLocationsModule': {'locations': [{'zip': '100037', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Minjie Lu, PhD', 'role': 'CONTACT', 'email': 'coolkan@163.com', 'phone': '+86 10 88398175'}], 'facility': 'Fuwai Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Minjie Lu', 'role': 'CONTACT', 'email': 'coolkan@163.com', 'phone': '13681042022'}, {'name': 'Baiyan Zhuang', 'role': 'CONTACT', 'email': 'zbyan10@163.com', 'phone': '+8613661168732'}], 'overallOfficials': [{'name': 'Minjie Lu', 'role': 'STUDY_CHAIR', 'affiliation': 'Chinese Academy of Medical Sciences, Fuwai Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese Academy of Medical Sciences, Fuwai Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief Doctor', 'investigatorFullName': 'Minjie Lu', 'investigatorAffiliation': 'Chinese Academy of Medical Sciences, Fuwai Hospital'}}}}