Four-Dimensional Flow MRI for Cardiovascular Evaluation (4DCarE): A Prospective Non-Inferiority Study of a Rapid Cardiac MRI Exam: Study Protocol and Pilot Analysis
Background: Accurate measurements of flow and ventricular volume and function are critical for clinical decision-making in cardiovascular medicine. Cardiac magnetic resonance (CMR) is the current gold standard for ventricular functional evaluation but is relatively expensive and time-consuming, thus...
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MDPI AG
2024-11-01
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| Series: | Diagnostics |
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| Online Access: | https://www.mdpi.com/2075-4418/14/22/2590 |
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| author | Jiaxing Jason Qin Mustafa Gok Alireza Gholipour Jordan LoPilato Max Kirkby Christopher Poole Paul Smith Rominder Grover Stuart M. Grieve |
| author_facet | Jiaxing Jason Qin Mustafa Gok Alireza Gholipour Jordan LoPilato Max Kirkby Christopher Poole Paul Smith Rominder Grover Stuart M. Grieve |
| author_sort | Jiaxing Jason Qin |
| collection | DOAJ |
| description | Background: Accurate measurements of flow and ventricular volume and function are critical for clinical decision-making in cardiovascular medicine. Cardiac magnetic resonance (CMR) is the current gold standard for ventricular functional evaluation but is relatively expensive and time-consuming, thus limiting the scale of clinical applications. New volumetric acquisition techniques, such as four-dimensional flow (4D-flow) and three-dimensional volumetric cine (3D-cine) MRI, could potentially reduce acquisition time without loss in accuracy; however, this has not been formally tested on a large scale. Methods: 4DCarE (4D-flow MRI for cardiovascular evaluation) is a prospective, multi-centre study designed to test the non-inferiority of a compressed 20 min exam based on volumetric CMR compared with a conventional CMR exam (45–60 min). The compressed exam utilises 4D-flow together with a single breath-hold 3D-cine to provide a rapid, accurate quantitative assessment of the whole heart function. Outcome measures are (i) flow and chamber volume measurements and (ii) overall functional evaluation. Secondary analyses will explore clinical applications of 4D-flow-derived parameters, including wall shear stress, flow kinetic energy quantification, and vortex analysis in large-scale cohorts. A target of 1200 participants will enter the study across three sites. The analysis will be performed at a single core laboratory site. Pilot Results: We present a pilot analysis of 196 participants comparing flow measurements obtained by 4D-flow and conventional 2D phase contrast, which demonstrated moderate–good consistency in ascending aorta and main pulmonary artery flow measurements between the two techniques. Four-dimensional flow underestimated the flow compared with 2D-PC, by approximately 3 mL/beat in both vessels. Conclusions: We present the study protocol of a prospective non-inferiority study of a rapid cardiac MRI exam compared with conventional CMR. The pilot analysis supports the continuation of the study. Study Registration: This study is registered with the Australia and New Zealand Clinical Trials Registry (Registry number ACTRN12622000047796, Universal Trial Number: U1111-1270-6509, registered 17 January 2022—Retrospectively registered). |
| format | Article |
| id | doaj-art-6d34d8ae5020475cbc890f7b0f61a276 |
| institution | Kabale University |
| issn | 2075-4418 |
| language | English |
| publishDate | 2024-11-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Diagnostics |
| spelling | doaj-art-6d34d8ae5020475cbc890f7b0f61a2762024-11-26T18:00:02ZengMDPI AGDiagnostics2075-44182024-11-011422259010.3390/diagnostics14222590Four-Dimensional Flow MRI for Cardiovascular Evaluation (4DCarE): A Prospective Non-Inferiority Study of a Rapid Cardiac MRI Exam: Study Protocol and Pilot AnalysisJiaxing Jason Qin0Mustafa Gok1Alireza Gholipour2Jordan LoPilato3Max Kirkby4Christopher Poole5Paul Smith6Rominder Grover7Stuart M. Grieve8Imaging and Phenotyping Laboratory, Charles Perkins Centre, University of Sydney, Sydney, NSW 2006, AustraliaImaging and Phenotyping Laboratory, Charles Perkins Centre, University of Sydney, Sydney, NSW 2006, AustraliaImaging and Phenotyping Laboratory, Charles Perkins Centre, University of Sydney, Sydney, NSW 2006, AustraliaANU Medical School, Australian National University, Canberra, ACT 2601, AustraliaImaging and Phenotyping Laboratory, Charles Perkins Centre, University of Sydney, Sydney, NSW 2006, AustraliaImaging and Phenotyping Laboratory, Charles Perkins Centre, University of Sydney, Sydney, NSW 2006, AustraliaEpworth Radiology, Waurn Ponds, VIC 3216, AustraliaMacquarie University Hospital, Macquarie Park, NSW 2109, AustraliaImaging and Phenotyping Laboratory, Charles Perkins Centre, University of Sydney, Sydney, NSW 2006, AustraliaBackground: Accurate measurements of flow and ventricular volume and function are critical for clinical decision-making in cardiovascular medicine. Cardiac magnetic resonance (CMR) is the current gold standard for ventricular functional evaluation but is relatively expensive and time-consuming, thus limiting the scale of clinical applications. New volumetric acquisition techniques, such as four-dimensional flow (4D-flow) and three-dimensional volumetric cine (3D-cine) MRI, could potentially reduce acquisition time without loss in accuracy; however, this has not been formally tested on a large scale. Methods: 4DCarE (4D-flow MRI for cardiovascular evaluation) is a prospective, multi-centre study designed to test the non-inferiority of a compressed 20 min exam based on volumetric CMR compared with a conventional CMR exam (45–60 min). The compressed exam utilises 4D-flow together with a single breath-hold 3D-cine to provide a rapid, accurate quantitative assessment of the whole heart function. Outcome measures are (i) flow and chamber volume measurements and (ii) overall functional evaluation. Secondary analyses will explore clinical applications of 4D-flow-derived parameters, including wall shear stress, flow kinetic energy quantification, and vortex analysis in large-scale cohorts. A target of 1200 participants will enter the study across three sites. The analysis will be performed at a single core laboratory site. Pilot Results: We present a pilot analysis of 196 participants comparing flow measurements obtained by 4D-flow and conventional 2D phase contrast, which demonstrated moderate–good consistency in ascending aorta and main pulmonary artery flow measurements between the two techniques. Four-dimensional flow underestimated the flow compared with 2D-PC, by approximately 3 mL/beat in both vessels. Conclusions: We present the study protocol of a prospective non-inferiority study of a rapid cardiac MRI exam compared with conventional CMR. The pilot analysis supports the continuation of the study. Study Registration: This study is registered with the Australia and New Zealand Clinical Trials Registry (Registry number ACTRN12622000047796, Universal Trial Number: U1111-1270-6509, registered 17 January 2022—Retrospectively registered).https://www.mdpi.com/2075-4418/14/22/2590cardiac magnetic resonance imaging4D-flowcardiac imagingimaging analysisleft ventricular function |
| spellingShingle | Jiaxing Jason Qin Mustafa Gok Alireza Gholipour Jordan LoPilato Max Kirkby Christopher Poole Paul Smith Rominder Grover Stuart M. Grieve Four-Dimensional Flow MRI for Cardiovascular Evaluation (4DCarE): A Prospective Non-Inferiority Study of a Rapid Cardiac MRI Exam: Study Protocol and Pilot Analysis Diagnostics cardiac magnetic resonance imaging 4D-flow cardiac imaging imaging analysis left ventricular function |
| title | Four-Dimensional Flow MRI for Cardiovascular Evaluation (4DCarE): A Prospective Non-Inferiority Study of a Rapid Cardiac MRI Exam: Study Protocol and Pilot Analysis |
| title_full | Four-Dimensional Flow MRI for Cardiovascular Evaluation (4DCarE): A Prospective Non-Inferiority Study of a Rapid Cardiac MRI Exam: Study Protocol and Pilot Analysis |
| title_fullStr | Four-Dimensional Flow MRI for Cardiovascular Evaluation (4DCarE): A Prospective Non-Inferiority Study of a Rapid Cardiac MRI Exam: Study Protocol and Pilot Analysis |
| title_full_unstemmed | Four-Dimensional Flow MRI for Cardiovascular Evaluation (4DCarE): A Prospective Non-Inferiority Study of a Rapid Cardiac MRI Exam: Study Protocol and Pilot Analysis |
| title_short | Four-Dimensional Flow MRI for Cardiovascular Evaluation (4DCarE): A Prospective Non-Inferiority Study of a Rapid Cardiac MRI Exam: Study Protocol and Pilot Analysis |
| title_sort | four dimensional flow mri for cardiovascular evaluation 4dcare a prospective non inferiority study of a rapid cardiac mri exam study protocol and pilot analysis |
| topic | cardiac magnetic resonance imaging 4D-flow cardiac imaging imaging analysis left ventricular function |
| url | https://www.mdpi.com/2075-4418/14/22/2590 |
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