Changes in aortic blood flow over several years in patients with diseases of the aortic valve measured by cardiac MRI
| ISRCTN | ISRCTN17935517 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17935517 |
| Secondary identifying numbers | 4D FU (internal study code) |
- Submission date
- 04/07/2018
- Registration date
- 07/08/2018
- Last edited
- 21/09/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
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
aortic valve.
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
Berlin
Germany
13125
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
stephanie.funk@charite.de
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 longitudinal single-center study over the time of up to 7 years |
|---|---|
| Primary study design | Observational |
| Secondary study design | Longitudinal study |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | 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 |
| Study objectives | 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. |
| Ethics approval(s) | Charité University of Berlin, 27/07/2011, EA1/183/11 |
| Health condition(s) or problem(s) studied | Patients with tricuspid aortic valve or bicuspid aortic valve, with or without stenosis. |
| Intervention | 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. |
| Intervention type | Procedure/Surgery |
| 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 2. Volumes 3. Wall shear stress |
| Secondary outcome measures | N/A |
| Overall study start date | 12/11/2009 |
| Completion date | 31/05/2018 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 70 |
| Key inclusion criteria | 1. Over 18 years of age 2. Written consent 3. Known aortic stenosis and/or bicuspid aortic valve |
| Key exclusion criteria | 1. Claustrophobia 2. Contraindications to CMR, including implants or metallic objects 3. Pregnant |
| Date of first enrolment | 27/07/2011 |
| Date of final enrolment | 01/05/2018 |
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
Not defined
No information available
Results and Publications
| Intention to publish date | 31/05/2019 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Published in a high-ranking peer-reviewed journal |
| IPD sharing plan | 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. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 14/02/2023 | 21/09/2023 | Yes | No |
Editorial Notes
21/09/2023: Publication reference added.
