Indication, UnlabeledEval-4DFlowNCT03986645
Clinical Evaluation of 4D Flow Cardiac MRI Sequences
A study testing MR data acquisition in people with Indication, Unlabeled, run by Emanuela Valsangiacomo.
Trial summary
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Indication, Unlabeled
- What is being tested?
- MR data acquisition
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2016to 30 Sep 2018
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
- 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.
Who cannot join
- 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.
- Any contraindication for undergoing a cMRI examination per internal institutional policy of University Children's Hospital Zurich
About this study
Official title: 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.
Read the 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 .
- Conditions
- Indication, Unlabeled
- Being tested
- MR data acquisition
- Keywords
- 4DFlow
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MR data acquisitionDevice
MR data acquisition using CE and non-CE marked pulse sequences.
| Study group | Role | What they receive |
|---|---|---|
| 4DFLOW | Experimental | Acquire MR 4DFLow data. Receives: Device: MR data acquisition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of data processing
Comparison of flow velocities and blood flow measured by 4D flow cMRI pulse sequences against phantom corrected 2D cMRI data.
Measured: Within 72 hours after completion of exam
Secondary outcomes (3)
Image quality
Qualitative grading of 4D flow cMRI anatomical images for image quality using a numerical scale.
Measured: 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.
Measured: 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.
Measured: Within 72 hours after completion of exam
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2019
- Study start1 Oct 2016
- Primary completion30 Sep 2018
- Study completion30 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Indication, UnlabeledStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective, exploratory, non-randomized, interventional study without control group.
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emanuela Valsangiacomo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Emanuela Valsangiacomo, University Children's Hospital, Zurich
- Investigators
- Emanuela Valsangiacomo, Prof. MD, Principal investigator, UChilldrenZurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03986645
- Sponsor's protocol ID
- CIV-16-11-017784
- Acronym
- Eval-4DFlow
- Status last verified
- Jun 2019
- First submitted
- 8 May 2019
- Last updated
- 14 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of 4D Flow Cardiac MRI Sequences - A Prospective Exploratory Study
- ClinicalTrials.gov ID
- NCT03986645
- Acronym / sponsor ID
- Eval-4DFlow / CIV-16-11-017784
- Conditions
- Indication, Unlabeled
- Keywords
- 4DFlow
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Emanuela ValsangiacomoUniversity, hospital or other
- Study start
- 1 Oct 2016 (actual)
- Primary completion
- 30 Sep 2018 (actual)
- Study completion
- 30 Sep 2018 (actual)
- First posted
- 14 Jun 2019 (actual)
- 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.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, exploratory, non-randomized, interventional study without control group.
| Arm | Type | Receives |
|---|---|---|
| 4DFLOW | Experimental | Device: MR data acquisitionAcquire MR 4DFLow data. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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
- Absence of any contraindication to cMRI
Key exclusion criteria (5 listed)
- 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.
- Any contraindication for undergoing a cMRI examination per internal institutional policy of University Children's Hospital Zurich
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 |
|---|---|---|
| MR data acquisitionMR data acquisition using CE and non-CE marked pulse sequences. | Device | 4DFLOW |
Primary outcome
Feasibility of data processing
Time frame: Within 72 hours after completion of exam
Comparison of flow velocities and blood flow measured by 4D flow cMRI pulse sequences against phantom corrected 2D cMRI data.
3 secondary outcomes
Image quality
Time frame: Within 72 hours after completion of exam
Comparability
Time frame: Within 72 hours after completion of exam
Clinical value
Time frame: Within 72 hours after completion of exam
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2019.
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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.
Emanuela Valsangiacomo, Prof. MD principal investigator
UChilldrenZurich
Questions about this trial
What is this clinical trial studying?
A study testing MR data acquisition in people with Indication, Unlabeled, run by Emanuela Valsangiacomo.
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 7 inclusion and 5 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: finished, as of the sponsor's last update on 14 Jun 2019. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Feasibility of data processing (time frame: Within 72 hours after completion of exam). 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 14 Jun 2019.