The current study aims to establish age-dependent and sex-specific normal values for novel imaging biomarkers using 4D flow MRI and CFD.
ID
Source
Brief title
Condition
- Aneurysms and artery dissections
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Description and quantification of regional hemodynamic parameters, blood flow
patterns, mechanical and structural properties of the aortic vessel wall and
transmural blood pressure in the aorta.
Secondary outcome
N/A
Background summary
The link between aortic aneurysm formation and the risk of acute complications
(rupture or dissection) has been well-described. Clinical management of
aneurysms is aimed at prevention of these complications by regular evaluation
of the maximum aortic diameter. Prophylactic aortic surgery is recommended when
aortic size exceeds diameter thresholds as defined in current clinical
guidelines. However, the value of aortic size as predictor for acute aortic
events is debated, as most dissection patients exhibit diameters below the
cut-offs for preventative aortic surgery. Using 4-dimensional flow magnetic
resonance imaging (4D flow MRI) and computational fluid dynamics (CFD)
modelling, the current study aims to describe new imaging biomarkers (e.g.
hemodynamical flow mapping, vessel wall mapping, and transmural blood pressure
mapping), which can improve the identification of patients at risk for aortic
dissection and rupture at an early stage.
Study objective
The current study aims to establish age-dependent and sex-specific normal
values for novel imaging biomarkers using 4D flow MRI and CFD.
Study design
This study is a multicentre observational study conducted at the Maastricht
University Medical Center (MUMC+) and Leiden University Medical Center (LUMC).
Study burden and risks
This is an observational study which has no therapeutic consequences. Flow MRI
scan protocols are routinely used in clinical practice and thus
non-experimental. Participants are not subject to ionizing radiation. No
contrast agent will be administered during the 4D flow MRI scans. Study results
will improve understanding of aneurysm formation and the occurrence of acute
natural complications. This data may provide for a better selection of patients
who will benefit from pre-emptive aortic surgery, and * eventually * to a
decrease in the incidence of potentially fatal aortic dissection and rupture.
P. Debyelaan 25
Maastricht 6229HX
NL
P. Debyelaan 25
Maastricht 6229HX
NL
Listed location countries
Age
Inclusion criteria
Age > 18 years old and <70 years old.
Mentally competent.
Informed written consent.
Exclusion criteria
Atrial fibrillation or tachycardia >100 bpm.
Hypertension (>140/90mmHg
Known aortic disease (aorta aneurysma, connective tissue disease, dissection,
or prior aortic surgery.
Chest pain suggestive for symptomatic aneurysm or acute aortic syndrome.
Contra-indication for MRI-examination
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL69521.068.19 |