Plain English Summary
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
Trial website
Contact information
Type
Scientific
Primary contact
Prof Jeanette Schulz-Menger
ORCID ID
http://orcid.org/0000-0003-3100-1092
Contact details
Charité University Medicine Berlin Campus Buch
Working Group Kardiale MRT Lindenberger Weg 80
Berlin
1325
Germany
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
4D Comparison (internal study code)
Study information
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
Acronym
Study hypothesis
Application of different techniques for measurement of haemodynamics in the Aorta ascendens does not have a significant influence on quantitative parameters.
Ethics approval
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
Study design
Observational feasibility study
Primary study design
Observational
Secondary study design
Feasibility study
Trial setting
Hospitals
Trial type
Diagnostic
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
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
Phase
Drug names
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 trial start date
01/06/2016
Overall trial end date
31/03/2018
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Age > 18 years
2. Written consent
Participant type
Healthy volunteer
Age group
Adult
Gender
Both
Target number of participants
10
Participant exclusion criteria
1. Any known cardiac disease
2. Contraindication to CMR
Recruitment start date
01/11/2016
Recruitment end date
31/05/2017
Locations
Countries of recruitment
Germany
Trial participating centre
Working Group on Cardiovascular Magnetic Resonance, Experimental and Clinical Research Center a joint cooperation between the Charité University Medicine Berlin and the Max-Delbrueck Center for Molecular Medicine, and HELIOS Klinikum Berlin Buch, Department of Cardiology and Nephrology, Berlin, Germany
Lindenberger Weg 80
Berlin
13125
Sponsor information
Organisation
Charité University Medicine Berlin
Sponsor details
Working Group Kardiale MRT Lindenberger Weg 80
Berlin
13125
Germany
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
Charité – Universitätsmedizin Berlin
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
corporate
Location
Germany
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer-reviewed journal, probably within the next year.
IPD sharing statement
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.
Intention to publish date
12/02/2019
Participant level data
Not expected to be available
Basic results (scientific)
Publication list