Assessment of Flow With the New Four-dimensional Velocity-encoded Magnetic Resonance Imaging Technique (4D Flow)
Primary Purpose
Congenital Heart Disease (CHD)
Status
Terminated
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
4D PC MRI acquisition
Sponsored by
About this trial
This is an interventional diagnostic trial for Congenital Heart Disease (CHD)
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Study Participants
Arm Description
4D PC MRI acquisition
Outcomes
Primary Outcome Measures
Pearson´s correlation coefficient (r)
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT02952287
First Posted
October 31, 2016
Last Updated
August 23, 2021
Sponsor
The Hospital for Sick Children
1. Study Identification
Unique Protocol Identification Number
NCT02952287
Brief Title
Assessment of Flow With the New Four-dimensional Velocity-encoded Magnetic Resonance Imaging Technique
Acronym
4D Flow
Official Title
Assessment of Flow With the New Four-dimensional Velocity-encoded Magnetic Resonance Imaging Technique
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Terminated
Why Stopped
Logistically recruitment was not applicable after trial of a few patients
Study Start Date
November 2016 (undefined)
Primary Completion Date
August 20, 2021 (Actual)
Study Completion Date
August 20, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hospital for Sick Children
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congenital Heart Disease (CHD)
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Study Participants
Arm Type
Experimental
Arm Description
4D PC MRI acquisition
Intervention Type
Device
Intervention Name(s)
4D PC MRI acquisition
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pearson´s correlation coefficient (r)
Description
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.
Time Frame
Six months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shi-Joon Yoo, MD
Organizational Affiliation
The Hospital for Sick Children
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Assessment of Flow With the New Four-dimensional Velocity-encoded Magnetic Resonance Imaging Technique
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