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Clinical Trials/NCT03986645
NCT03986645
Completed
Not Applicable

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

Emanuela Valsangiacomo0 sites8 target enrollmentOctober 1, 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Indication, Unlabeled
Sponsor
Emanuela Valsangiacomo
Enrollment
8
Primary Endpoint
Feasibility of data processing
Status
Completed
Last Updated
6 years ago

Overview

Brief 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 .

Registry
clinicaltrials.gov
Start Date
October 1, 2016
End Date
September 30, 2018
Last Updated
6 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Emanuela Valsangiacomo
Responsible Party
Sponsor Investigator
Principal Investigator

Emanuela Valsangiacomo

Prof.

University Children's Hospital, Zurich

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Image quality(Within 72 hours after completion of exam)
  • Clinical value(Within 72 hours after completion of exam)
  • Comparability(Within 72 hours after completion of exam)

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