NCT03986645

Clinical Evaluation of 4D Flow Cardiac MRI Sequences

Clinical Evaluation of 4D Flow Cardiac MRI Sequences - A Prospective Exploratory Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Emanuela Valsangiacomo · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Accepted

Summary

Assess the accuracy of 4D flow cardiac MRI to measure blood flow and velocity, delineate 3D cardiac anatomy and visualize flow dynamics using two (2) different pulse sequences.

Detailed description

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 .

Conditions

• Indication, Unlabeled

Interventions

Type	Name	Description
DEVICE	MR data acquisition	MR data acquisition using CE and non-CE marked pulse sequences.

Timeline

• Start date: 2016-10-01
• Primary completion: 2018-09-30
• Completion: 2018-09-30
• First posted: 2019-06-14
• Last updated: 2019-06-14