Plain English Summary
Background and study aims
4D flow is a newly developed MRI scanner that allows blood flow to be visualized and quantified. This means that blood flow pattern, volumes, velocity (aortic hemodynamics) can be examined, along with wall shear stress, which shows whether the aorta is affected by cardiac disease.
Aortic stenosis, where the opening of the aortic valve is constricted, and bicuspid valves, are
both forms of aortic valve disease. This can lead to altered blood flow patterns and increased
wall shear stress. This study aims to investigate the changes in aortic blood flow and wall shear
stress over time in patients with aortic valve diseases.
Who can participate?
Patients over 18 years of age with either a tricuspid aortic valve with stenosis or a bicuspid
What does the study involve?
Each patient receives two cardiovascular MRI examinations. The first is after inclusion in the
study and the second is 4-7 years later.
What are the possible benefits and risks of participating?
A benefit to patients is a thorough, high-level examination of the heart. Clinically relevant information on the disease can be made available to the participant upon request and the participant will be made aware of any incidental pathological findings.
The possible risk to patients is the use of a magnetic field to collect the images, which means
that any metallic (magnetic) objects, along with objects within the body (such as implants) are
of risk. Additionally, there is a small risk of temporary dizziness and light flashes whilst leaving
the MRI scanner.
Where is the study run from?
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
Lindenberger Weg 80
When is the study starting and how long is it expected to run for?
The study started in November 2009 and will run until May 2018.
Who is funding the study?
Working Group Kardiale MRT of the Charité University Medicine Berlin.
Who is the main contact?
Professor Jeanette Schulz-Menger
Prof Jeanette Schulz-Menger
Charité University Medicine Berlin Campus Buch Working Group Kardiale MRT Lindenberger Weg 80
4D FU (internal study code)
Longitudinal evaluation of aortic hemodynamics in patients with aortic stenosis and patients with bicuspid aortic valve using 4D flow in cardiovascular magnetic resonance imaging - A follow up investigation
4D flow MRI can show changes of aortic flow patterns and additional hemodynamic parameters such as wall shear stress in patients with aortic valve pathologies over time. The pattern of aortic blood flow turbulences, and extent and degree of the wall shear stress can predict development or progress of changes in the ascending aorta.
Charité University of Berlin, 27/07/2011, EA1/183/11
Observational longitudinal single-center study over the time of up to 7 years
Primary study design
Secondary study design
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Patients with tricuspid aortic valve or bicuspid aortic valve, with or without stenosis.
Two cardiac magnetic resonance examinations were performed per patient to acquire images displaying the aortic flow. Each patient received one examination after inclusion in the study and one 4 to 7 years later. The examination took approximately 1 hour and was performed using 3 Tesla Siemens Verio Scanner and was without application of contrast agent or any other drug. A physician specialising in cardiac MRI was present during the whole time of the examination.
Primary outcome measure
Images of the aorta and aortic flow were acquired using 4D flow MRI at the beginning of the study and 4-7 years following this. These images were analysed for the following and the results from each time point compared:
1. Flow patterns
3. Wall shear stress
Secondary outcome measures
Overall trial start date
Overall trial end date
Reason abandoned (if study stopped)
Participant inclusion criteria
1. Over 18 years of age
2. Written consent
3. Known aortic stenosis and/or bicuspid aortic valve
Target number of participants
Participant exclusion criteria
2. Contraindications to CMR, including implants or metallic objects
Recruitment start date
Recruitment end date
Countries of recruitment
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
Charité University Medicine Berlin
Working Group Kardiale MRT Lindenberger Weg 80
Charité University Medicine Berlin - Working Group Kardiale MRT
Funding Body Type
Funding Body Subtype
Results and Publications
Publication and dissemination plan
Published in a high-ranking peer-reviewed journal
IPD sharing statement: The datasets generated during and/or analysed during the current study are not expected to be made available due to reasons of data protection laws in Germany. However, upon request methodology and data set structure can be shared.
Intention to publish date
Participant level data
Not expected to be available
Basic results (scientific)