Congenital Heart Disease (CHD)4D FlowNCT02952287
Assessment of Flow With the New Four-dimensional Velocity-encoded Magnetic Resonance Imaging Technique
A study testing 4D PC MRI acquisition in people with Congenital Heart Disease (CHD), run by The Hospital for Sick Children.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 day to 18 years
- Conditions the study is for
- Congenital Heart Disease (CHD)
- What is being tested?
- 4D PC MRI acquisition
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Nov 2016to 20 Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
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.
Read the 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.
- Conditions
- Congenital Heart Disease (CHD)
- Being tested
- 4D PC MRI acquisition
- Medical subject headings
- Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
4D PC MRI acquisitionDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Study Participants | Experimental | 4D PC MRI acquisition Receives: Device: 4D PC MRI acquisition |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2016 (estimated)
- Study startNov 2016
- Primary completion20 Aug 2021
- Study completion20 Aug 2021
Why it stopped: Logistically recruitment was not applicable after trial of a few patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Heart Disease (CHD)Studies of the same condition, open and under way.
- More trials run by The Hospital for Sick ChildrenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shi-Joon Yoo, The Hospital for Sick Children
- Investigators
- Shi-Joon Yoo, MD, Principal investigator, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02952287
- Sponsor's protocol ID
- REB1000050375
- Acronym
- 4D Flow
- Status last verified
- Aug 2021
- First submitted
- 31 Oct 2016
- Last updated
- 27 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Flow With the New Four-dimensional Velocity-encoded Magnetic Resonance Imaging Technique
- ClinicalTrials.gov ID
- NCT02952287
- Acronym / sponsor ID
- 4D Flow / REB1000050375
- Conditions
- Congenital Heart Disease (CHD)
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Logistically recruitment was not applicable after trial of a few patients
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Study start
- Nov 2016
- Primary completion
- 20 Aug 2021 (actual)
- Study completion
- 20 Aug 2021 (actual)
- First posted
- 2 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Participants | Experimental | Device: 4D PC MRI acquisition4D PC MRI acquisition |
Who may qualify
- Ages
- 1 day to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 4D PC MRI acquisitionFlow-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. | Device | Study Participants |
Primary outcome
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.
Results and safety
The study was stopped early (reason given: Logistically recruitment was not applicable after trial of a few patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shi-Joon Yoo, MD principal investigator
The Hospital for Sick Children
Questions about this trial
What is this clinical trial studying?
A study testing 4D PC MRI acquisition in people with Congenital Heart Disease (CHD), run by The Hospital for Sick Children.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Logistically recruitment was not applicable after trial of a few patients). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pearson´s correlation coefficient (r) (time frame: Six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2021.