search
Back to results

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
The Hospital for Sick Children
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Congenital Heart Disease (CHD)

Eligibility Criteria

1 Day - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    October 31, 2016
    Last Updated
    August 23, 2021
    Sponsor
    The Hospital for Sick Children
    search

    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

    We'll reach out to this number within 24 hrs