Clinical Evaluation of 4D Flow Cardiac MRI Sequences (Eval-4DFlow)
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|ClinicalTrials.gov Identifier: NCT03986645|
Recruitment Status : Completed
First Posted : June 14, 2019
Last Update Posted : June 14, 2019
|Condition or disease||Intervention/treatment||Phase|
|Indication, Unlabeled||Device: MR data acquisition||Not Applicable|
Advances in pediatric (cardiac) surgery, interventional techniques and medical care have improved survival for children born with congenital heart disease. Assessment of blood flow and pressures within the heart plays an integral role in the management of patients with congenital or acquired structural heart disease aiding with diagnoses, surveillance for complications, in relation to surgical or catheter procedures, and for therapeutic decision making. Current gold standard, direct intracardiac measurement of flow and pressures is an invasive procedure, while non-invasive echography-Doppler is limited by poor acoustic windows and operator dependency.
Therefore, cardiac MRI (cMRI) has been recommended as an important alternative in imaging of pediatric heart disease. Current clinical standard for MR flow imaging is 2-dimensional providing flow in a single cross-sectional plane. Current clinical CMR protocols in pediatric congenital heart disease are time consuming, depend on technician's experience and require direct supervision by an experienced cardiovascular imaging specialist. 4D Flow is a new approach for cMRI that might overcome these disadvantages. It allows scanning of the entire chest in approximately 7 minutes (depending on field of view, heart rate and resolution). The images can be off-line reconstructed in any plane, avoiding the need to precisely define crosssectional planes during acquisition for each vessel. Owing to time resolved visualizations of intracardiac flow dynamics occult jets or dynamic jets might be more likely to be detected. Potential disadvantages, rsp. potential advantages to be confirmed include lower temporal resolution of 4D sequences than current 2D sequences, unknown consequences of gradient artefacts induced by new velocity encoding schemes and diagnostic plausibility of disease related image features .
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||8 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Prospective, exploratory, non-randomized, interventional study without control group.|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Clinical Evaluation of 4D Flow Cardiac MRI Sequences - A Prospective Exploratory Study|
|Actual Study Start Date :||October 1, 2016|
|Actual Primary Completion Date :||September 30, 2018|
|Actual Study Completion Date :||September 30, 2018|
Acquire MR 4DFLow data.
Device: MR data acquisition
MR data acquisition using CE and non-CE marked pulse sequences.
- Feasibility of data processing [ Time Frame: Within 72 hours after completion of exam ]Comparison of flow velocities and blood flow measured by 4D flow cMRI pulse sequences against phantom corrected 2D cMRI data.
- Image quality [ Time Frame: Within 72 hours after completion of exam ]Qualitative grading of 4D flow cMRI anatomical images for image quality using a numerical scale.
- Comparability [ Time Frame: Within 72 hours after completion of exam ]Qualitative grading of comparability of anatomical findings in 4D flow cMRI anatomical images with contrast-enhanced MR angiography images, if these have been acquired during the clinical examination of patients, using a numerical scale.
- Clinical value [ Time Frame: Within 72 hours after completion of exam ]Qualitative grading of clinical and diagnostic value of visualizations of flow dynamics using a numerical scale.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03986645
|Principal Investigator:||Emanuela Valsangiacomo, Prof. MD||UChilldrenZurich|