Analysis of blood flow in the aorta and heart structure in heart and blood vessels diseases using magnetic resonance imaging
| ISRCTN | ISRCTN14567789 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14567789 |
| Secondary identifying numbers | CIV-18-01-022805 |
- Submission date
- 13/04/2023
- Registration date
- 31/05/2023
- Last edited
- 13/05/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
Background and study aims
In patients with heart and blood vessel diseases, changes occur in the way blood flows through the aorta (the main artery) and the structure of the heart. These changes are important because they affect the overall function of the heart and the delivery of oxygenated blood to the body. When people have heart and blood vessel diseases, the aorta may have blockages or blood clots, which can reduce blood flow. This means that organs and tissues may not receive enough oxygen and nutrients. Additionally, the structure of the heart can become abnormal, leading to problems with pumping blood effectively. These issues contribute to the progression of cardiovascular diseases.
A 7T MRI (Magnetic Resonance Imaging) machine is a powerful medical imaging device that uses a strong magnetic field to create detailed pictures of the inside of the body. It provides higher resolution and more accurate images compared to lower strength MRI machines, aiding in better diagnosis and treatment planning.
The study aims to assess blood flow in the aorta and heart structure in patients with heart and blood vessel diseases using 7T MRI.
Who can participate?
Adult patients with heart diseases: aortic valve pathologies, hypertrophic heart disease with obstruction and patients with hypertension.
What does the study involve?
7T MRI scan of the heart and aorta for 60 minutes.
What are the possible benefits and risks of participating?
Benefits: New insight into diseases and interaction of the pathology with heart function and tissue can be obtained in higher resolution and reduction of the measuring time
Risks: Dizziness, hot or cold feeling, seeing flashes, muscle contractions, nausea.
Where is the study run from?
Charité - Universitätsmedizin Berlin (Germany)
When is the study starting and how long is it expected to run for?
January 2018 to May 2024
Who is funding the study?
Charité - Universitätsmedizin Berlin (Germany)
Who is the main contact?
Univ.-Pro.Dr.med Jeanette Schulz-Menger
jeanette.schulz-menger@charite.de
Contact information
Scientific
Lindenberger Weg 80
Berlin
13125
Germany
| Phone | +49 (0)30 450 540611 |
|---|---|
| elias.daud@charite.de |
Study information
| Study design | Monocentric observational cross-sectional cohort study non-randomized open study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cross sectional study |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | No participant information sheet available |
| Scientific title | Assessment of the interaction between myocardial structure and hemodynamics in the ascending aorta in cardiovascular diseases with alteration of the outflow tract and the aortic valve using ultra-high-field magnetic resonance imaging |
| Study objectives | Non-invasive analysis of hemodynamics in the ascending aorta and left ventricular outflow tract (LVOT) in cardiovascular diseases using 7T MRI. |
| Ethics approval(s) | Approved 09/07/2018, Landesamt fuer Gesundheit und Soziales Ethik Kommission des Landes Berlin (Fehrberliner Platz 1, 10707 Berlin, Germany; +49 30902291226; Elen.eisenstadt@lageso.berline.de), ref: CIV-18-01-022805 |
| Health condition(s) or problem(s) studied | Cardiovascular diseases: aortic valve pathologies (aortic stenosis/insufficiency), hypertrophic cardiomyopathy, muscle dystrophy, heart failure with preserved ejection fraction (HFpEF), hypertension, inflammation, connective tissue disease |
| Intervention | Observational study: ultra-high-field magnetic resonance imaging 7T. The hemodynamics in the aorta as well as in the LVOT can be measured using 4D flow MRI. In addition, cardiovascular MRI (CMR) in 7T also allows the detection of microstructural changes due to the increased temporal resolution. |
| Intervention type | Other |
| Primary outcome measure | Evaluation of the hemodynamics in the left ventricular outflow tract area using 4D MRI on the 7T MRI: 1. Flow Volumes (forward and reverse flow in ml) 2. Wall shear forces in N/m² 3. Blood flow velocities in m/s |
| Secondary outcome measures | There are no secondary outcome measures |
| Overall study start date | 24/01/2018 |
| Completion date | 01/05/2024 |
Eligibility
| Participant type(s) | Mixed |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 150 |
| Total final enrolment | 150 |
| Key inclusion criteria | Healthy volunteers: 1. Aged at least 18 years Patients 1. Presence of one of the following pathologies: aortic valve pathology, hypertension, hypertrophic cardiomyopathy with narrowing of the LVOT 2. Informed consent 3. Legal capacity 4. Aged at least 18 years |
| Key exclusion criteria | 1. Claustrophobia 2. Any implants (e.g. pacemaker, ICD, clips, joint prostheses, >1 coronary stent) 3. Age under 18 years 4. Pregnancy, lactation 5. Rejection by patients 6. Large tattoos on the upper body (relative contraindication; individual decision together with the participant) 7. Not capable of consent 8. Placement in an institution by official or court order 9. Dependence on the investigator, trial site or sponsor |
| Date of first enrolment | 01/05/2019 |
| Date of final enrolment | 01/05/2024 |
Locations
Countries of recruitment
- Germany
Study participating centre
Berlin
13125
Germany
Sponsor information
Hospital/treatment centre
Chariteplatz 1
Berlin
10117
Germany
| Phone | +49 (0)30 450 50 |
|---|---|
| jeanette.schulz-menger@charite.de | |
| Website | https://www.charite.de/en/ |
"ROR" |
https://ror.org/001w7jn25 |
Funders
Funder type
Hospital/treatment centre
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 | 01/05/2026 |
|---|---|
| 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 |
| IPD sharing plan | Core data can be requested upon reasonable request from the principal investigator. The datasets generated during and/or analysed during the current study are not expected to be made available due to German data protection laws. |
Editorial Notes
13/05/2024: Total final enrolment added.
07/05/2024: The intention to publish date was changed from 01/05/2025 to 01/05/2026.
09/05/2023: Trial's existence confirmed by Landesamt fuer Gesundheit und Soziales Ethik Kommission des Landes Berlin.
