Comparison of different techniques and different scanner types for visualization and quantification of aortic blood flow by cardiovascular magnetic resonance
| ISRCTN | ISRCTN37755721 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN37755721 |
| Secondary identifying numbers | 4D Comparison (internal study code) |
- Submission date
- 08/02/2018
- Registration date
- 15/03/2018
- Last edited
- 17/06/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
Background and study aims
Two-dimensional flow imaging in cardiac (heart) MRI is a standard technique and well established. However, it only measures blood flow volumes in one cross-sectional plane of the aorta, so it cannot give information about wall shear stress or maximum velocity. A newly developed sequence for cardiovascular MRI can be used to measure blood flow and its impact on surrounding tissue in three dimensions and over time (i.e. over one cardiac cycle) - the common name for the sequence is therefore 4D-Flow. Blood flow pattern, volume and velocity can all be measured. The wall-shear stress of the aorta (the largest artery) can be examined, showing where the aorta is affected and altered by cardiac pathology (heart disease). Different types of this sequence have been developed, and it can be used at MRI scanners of different field strengths. It is important to know whether there are differences in the results when using different sequences or MRI scanners. The aim of this study is to compare three different sequences and three different field strengths in healthy volunteers, and to compare all 4D-Flow exams to the reference of two-dimensional flow measurement.
Who can participate?
Healthy volunteers, aged over 18
What does the study involve?
Three different sequences and three different field strengths are compared in healthy volunteers. All 4D Flow scans are assessed to measure blood flow in the thoracic aorta, wall shear stress and peak velocity, and are compared with two-dimensional flow measurement.
What are the possible benefits and risks of participating?
Cardiac MRI is considered the gold standard for measuring heart function. Participants may benefit from a thorough, high-level examination of the heart. Results can - upon request - be made available to the participant. Any incidental pathological findings are communicated with the participant as well. Future patients may benefit from a useful diagnostic tool in clinical routine. 4D Flow has been proven to provide additional information in certain pathologies and can help with guiding treatment. Standardization of the technique is crucial for its use in clinical routine. The risk of an MRI exam are generally small (seldom temporary dizziness and light flashes, ending with leaving the MRI scanner). The biggest risk centers around the fact that a magnetic field is induced to gather the images. Therefore, metallic (magnetic) objects are of risk, including objects within the body such as implants. This is a general limitation for the use of MRI and is therefore also applied in this study. People with any kind of implant or metal within or on the body cannot participate.
Where is the study run from?
Charité University Medicine Berlin (Germany)
When is the study starting and how long is it expected to run for?
June 2016 to March 2018
Who is funding the study?
Charité University Medicine Berlin (Germany)
Who is the main contact?
Prof. Jeanette Schulz-Menger
Contact information
Scientific
Charité University Medicine Berlin Campus Buch
Working Group Kardiale MRT Lindenberger Weg 80
Berlin
1325
Germany
 ORCID ID |
0000-0003-3100-1092 |
|---|
Study information
| Study design | Observational feasibility study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Feasibility study |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Impact of field strength (1.5, 3.0 and 7.0 Tesla) and sequence on quantification of aortic flow volumes, peak velocity and wall shear stress using 4D flow MRI |
| Study objectives | Application of different techniques for measurement of haemodynamics in the Aorta ascendens does not have a significant influence on quantitative parameters. |
| Ethics approval(s) | The ethics board of the Charité University Medicine Berlin Campus Mitte: 1. 1.5 Tesla and 3.0 Tesla: 09/11/2012, ref: EA 1/258/12 2. First amendment: 30/05/2014 3. 7.0 Tesla: 25/08/2009, ref: EA 1/054/09 |
| Health condition(s) or problem(s) studied | Healthy volunteers without any known cardiac disease |
| Intervention | This is an observational study comparing three different techniques of visualization of blood flow in the aorta ascendens at three different cardiac MRI scanners with different field strengths (1.5 Tesla, 3.0 Tesla, 7.0 Tesla) in healthy volunteers. It serves at the same time as a feasibility study of this particular technique at 7.0 Tesla cardiac MRI. Three different sequences and three different field strengths (1.5 Tesla, 3.0 Tesla and 7.0 Tesla) are compared in 10 healthy volunteers. All 4D-Flow exams are also compared to the reference of two-dimensional flow measurement. All 4D Flow scans are assessed as follows: blood flow in the thoracic aorta is visualized, forward-, backward- and net- flow is quantified. Wall shear stress and peak velocity are visualized and quantified. In the reference two-dimensional flow measurement forward-, backward- and net-flow is quantified. |
| Intervention type | Other |
| Primary outcome measure | Blood flow volume in the thoracic aorta in each tested MR sequence over one cardiac cycle measured by three-dimensional cardiac magnetic resonance |
| Secondary outcome measures | Velocity of the blood flow and wall shear stress in the ascending aorta in each tested MR sequence over one cardiac cycle measured by three-dimensional cardiac magnetic resonance |
| Overall study start date | 01/06/2016 |
| Completion date | 31/03/2018 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 10 |
| Key inclusion criteria | 1. Age > 18 years 2. Written consent |
| Key exclusion criteria | 1. Any known cardiac disease 2. Contraindication to CMR |
| Date of first enrolment | 01/11/2016 |
| Date of final enrolment | 31/05/2017 |
Locations
Countries of recruitment
- Germany
Study participating centre
Berlin
13125
Germany
Sponsor information
University/education
Working Group Kardiale MRT Lindenberger Weg 80
Berlin
13125
Germany
| Website | http://www.cmr-berlin.org |
|---|---|
"ROR" |
https://ror.org/001w7jn25 |
Funders
Funder type
University/education
Private sector organisation / For-profit companies (industry)
- Alternative name(s)
- Medical School - Charité - University Medicine Berlin
- Location
- Germany
Results and Publications
| Intention to publish date | 12/02/2019 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal, probably within the next year. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are not expected to be made available due to data protection laws in Germany. However, upon request methodology and dataset structure can be shared. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Other publications | Retrospective analysis using study data to compare the results of two different commercially available software packages and their impact on different hemodynamic parameters | 27/09/2024 | 17/06/2025 | Yes | No |
| Results article | 04/08/2020 | 17/06/2025 | Yes | No |
Editorial Notes
17/06/2025: Publication reference added.
