optimization of a new 3 Tesla Magnetic Resonance Imaging protocol for imaging of the aortic vessel wall in order to enhance the identification of individuals at highest risk of developing clinically manifest atherosclerosis
ID
Source
Brief title
Condition
- Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1) inter scan reproducibility, in comparison to existing methods
2) acquisition time in comparison to current scanning protocol
3) comparability of vascular wall images using previously performed CT scan as
the reference standard
Secondary outcome
NA
Background summary
The relevance of the proposed study lies in the optimization of a new 3 Tesla
Magnetic Resonance Imaging protocol to visualize the aortic vessel wall
Study objective
optimization of a new 3 Tesla Magnetic Resonance Imaging protocol for imaging
of the aortic vessel wall in order to enhance the identification of individuals
at highest risk of developing clinically manifest atherosclerosis
Study design
cross-sectional study
Study burden and risks
We believe the benefits of the study will outweigh the risks and burden. The
procedures performed are safe, without (long term) side effects and do no harm
to the subject. The burden for the participants is little: only two times (at
baseline and 4 weeks thereafter), participants will undergo an MR imaging
examination. The most important potential risk is the administration of
contrast agent. However, the gadolinium chelate gadobutrol (Gadovist) belongs
to the safest class of MRI contrast agent. In fact it is the standard contrast
agent used for MRI examinations in the clinical setting. As such, it is
administered to thousands of patients every year in our hospital. Not only is
the frequency of side effects of Gadovist very low, if a side effect occurs, it
is easy to treat, therefore health risks are minimal. In addition, if subjects
are known to be allergic to contrast agents or have severe renal impairments,
they are excluded from participation. Moreover, using MRI has several
advantages: it is a safe procedure; does not use radiation and is suitable for
repeated measurement without side effects; and is well-suited to assess
various stages of atherosclerosis in a reproducible manner. Furthermore, MRI is
able to distinguish between various components of atherosclerotic lesions
(lipid core, thin caps, intra plaque hemorrhage) and atherosclerosis can
already be assessed at a young age. The insights gained from this study may
pave the way to enhance the identification of individuals at highest risk of
developing clinically manifest atherosclerosis by using an appropriate,
time-efficient MRI protocol.
Heidelberglaan 100
Utrecht 3584 CX
NL
Heidelberglaan 100
Utrecht 3584 CX
NL
Listed location countries
Age
Inclusion criteria
- male or female
- volunteers
- 18 years or older
- Undergone cardiac triggered CT scan on which the aorta is visualized
- At least 1 plaque present in the aorta (defined as: luminal protrusion of > 1 mm
in radial thickness);The maximum acceptable time interval between the performed CT-scanning and the MRI scan that will be performed for this study is at theis utmost 6 weeks.
Exclusion criteria
- pregnancy
- documented allergic reaction to gadolinium
- renal function below normal (GFR < 60ml/min)
- impossibility to undergo MRI (determined by using the standard contraindications for MR imaging as used for clinical purposes)
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 | NL49505.041.14 |