Assessment of Flow With the New Four-dimensional Velocity-encoded Magnetic Resonance Imaging Technique (4D Flow)
August 23, 2021 updated by: Shi-Joon Yoo, The Hospital for Sick Children
The purpose of our study is to validate the accuracy of 4D PC flow method in quantification of thoracic and upper abdominal blood flow volumes in children.
In this validation study, 4D PC flow method will be applied in 100 pediatric patients undergoing clinically indicated CMR with 2D PC flow measurement.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Detailed Description
Measurement of blood flow in vessels leading to or arising from the heart is one of the key features of Cardiac Magnetic Resonance (CMR).
With standard 2D phase contrast (PC) flow measurements, each vessel is measured separately at a predefined location.
Planning and scanning can be time consuming while the patient is inside the scanner.
In addition, when the scan time is long, the hemodynamics may be assessed at different physiological states.
In contrast to a 2D PC acquisition 4D PC captures all the information about blood flow velocities within a 3D anatomical volume.
Once this predefined volume has been acquired, the flow within the heart and vessels of interest can be measured at any desired location offline, i.e. after the patient has left the scanner.
This is especially advantageous in cases where multiple 2D PC MRI scans are needed such as in congenital heart disease (CHD).
In addition to standard measurements, 4D PC provides flow patterns, which might change our current understanding of pathologic flow conditions.
Although there has been increasing interest in this new technique, only a few papers have proved its accuracy in adult population.
The purpose of our study is to validate the accuracy of 4D PC flow method in quantification of thoracic and upper abdominal blood flow volumes in children.
In this validation study, 4D PC flow method will be applied in 100 pediatric patients undergoing clinically indicated CMR with 2D PC flow measurement.
Study Type
Interventional
Enrollment (Anticipated)
100
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 day to 18 years (ADULT, CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- All pediatric patients under 18 years of age undergoing CMR with 2D PC flow measurements as a clinically indicated component of the examination at The Hospital for Sick Children, Toronto, ON.
- Ability to undergo an MRI examination without anesthesia or sedation.
- Ability to undergo an MRI examination using 'Feed-and-Sleep' technique39
Exclusion Criteria:
- Refusal of consent / assent by parent / legal guardian / patient
- General contraindications for an MRI examination such as non-MRI compatible metallic implants, claustrophobia.
- Patients who require anaesthesia or sedation for MRI
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: DIAGNOSTIC
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Study Participants
4D PC MRI acquisition
|
Flow-sensitive 4D-MRI acquisitions will be synchronized to the heart rate and breathing using prospective ECG-gating and adaptive diaphragm navigator gating41.
The MRI sequence will consist of a segmented k-space spoiled gradient echo sequence with interleaved 3D velocity encoding.
Data will be acquired in a sagittal oblique 3D data volume individually adapted to include the heart and the thoracic and upper abdominal vessels of interest like ascending, transverse and descending aorta, main and branch pulmonary arteries, pulmonary veins, superior and inferior vena cava, celiac and superior mesenteric vessels.
Velocity encoding (VENC) will be set at 150-500 cm/sec to encompass flow in various vessels.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pearson´s correlation coefficient (r)
Time Frame: Six months
|
The association of variables (stroke volumes as measured with 2D and 4D flow, regurgitation fractions) will be investigated with Pearson´s correlation coefficient (r).
P values of <0.05 will be considered significant.
|
Six months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Shi-Joon Yoo, MD, The Hospital for Sick Children
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2016
Primary Completion (ACTUAL)
August 20, 2021
Study Completion (ACTUAL)
August 20, 2021
Study Registration Dates
First Submitted
October 31, 2016
First Submitted That Met QC Criteria
October 31, 2016
First Posted (ESTIMATE)
November 2, 2016
Study Record Updates
Last Update Posted (ACTUAL)
August 27, 2021
Last Update Submitted That Met QC Criteria
August 23, 2021
Last Verified
August 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REB1000050375
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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