Clinical Evaluation of 4D Flow Cardiac MRI Sequences (Eval-4DFlow)

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

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.

Study Overview

• Status: Completed
• Conditions: Indication, Unlabeled
• Intervention / Treatment: Device: MR data acquisition

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 .

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria Patients:

• Clinical referral for cMRI in the absence of any contraindication to cMRI
• Flow measurements are part of the clinical cMRI protocol
• Signed informed consent of participants and/or legal representatives according to current ethical rules and regulations for children and adults
• For females in reproductive age, exclusion of pregnancy by a pregnancy test conducted before the cMRI

Exclusion Criteria Patients:

• Any contraindication for undergoing a cMRI examination or for receiving gadolinium contrast media (renal failure, allergy) per internal institutional policy of University Children's Hospital Zurich
• Any intrathoracic device causing imaging artifacts
• Medical condition at time of examination that would make additional study-related MR scans an unjustified burden or risk.
• Inability or unwillingness to provide informed consent.

Inclusion Criteria Healthy Controls:

• Absence of any contraindication to cMRI
• Signed informed consent of participants according to current ethical rules and regulations
• For females in reproductive age, exclusion of pregnancy by a pregnancy test conducted before the cMRI.

Exclusion Criteria Healthy Controls:

- Any contraindication for undergoing a cMRI examination per internal institutional policy of University Children's Hospital Zurich

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 4DFLOW; Acquire MR 4DFLow data.	Device: MR data acquisition; MR data acquisition using CE and non-CE marked pulse sequences.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of data processing	Comparison of flow velocities and blood flow measured by 4D flow cMRI pulse sequences against phantom corrected 2D cMRI data.	Within 72 hours after completion of exam

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Image quality	Qualitative grading of 4D flow cMRI anatomical images for image quality using a numerical scale.	Within 72 hours after completion of exam
Comparability	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.	Within 72 hours after completion of exam
Clinical value	Qualitative grading of clinical and diagnostic value of visualizations of flow dynamics using a numerical scale.	Within 72 hours after completion of exam

Collaborators and Investigators

• Sponsor: Emanuela Valsangiacomo
• Investigators: Principal Investigator: Emanuela Valsangiacomo, Prof. MD, UChilldrenZurich

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2016
• Primary Completion (Actual): September 30, 2018
• Study Completion (Actual): September 30, 2018

Study Registration Dates

• First Submitted: May 8, 2019
• First Submitted That Met QC Criteria: June 12, 2019
• First Posted (Actual): June 14, 2019

Study Record Updates

• Last Update Posted (Actual): June 14, 2019
• Last Update Submitted That Met QC Criteria: June 12, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: 4DFlow
• Other Study ID Numbers: CIV-16-11-017784

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No