To study the feasiblity of cardiac MRI at 3T and the potential benefits of the intravascular contrast agent gadofosveset for studying and quantifiaction of heart function and -perfusion.
ID
Source
Brief title
Condition
- Heart failures
- Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
differences in objective and subjective MRI-image parameters between 1.5T and
3T (artefacts, signal-to-maise ratio, signal and contrast before, during and
after administration of contrast agent, subjective image quality, location and
extent of contrast agent uptake in the wall of the left ventricle).
Secondary outcome
not applicable
Background summary
Non-invasive diagnosis of cardiovascular diseases is strongly emerging.
Intra-arterial digital subtraction angiography used to be the standard of
reference for many clinical indications, but nowadays newer techniques like
echo-doppler, computer tomography (CT) and magnetic resonance imaging (MRI) are
more widely used. The latter, MRI, is currently considered to be the standard
of reference for studying heart function and size of myocardial infarctions.
Untill now, most cardiac MR studies have been performed at 1.5T MRI scanners.
Recently, 3T MRI scanners have become clinically available. At high field
strengths higher spatial resolution and shorter scan duration can be achieved.
Additionally, better visualization of myocardial perfusion might be obtained at
3T because of altered relaxivity of contrast agents at this field strength.
A major disadvantage of 3T MRI scanners is a the occurence of artefacts due to
magnetic field inhomogeneities. However, a recent study demonstrated a
beneficial effect of intravascular contrast agents: artefacts were reduced at
3T when using the intravascular agent gadomer-17. In our study we will use
Gadofosveset, an intravascular albumin binding contrast agent (reversible
binding). It has a longer intravascular half life and a higher relaxivity
compared to other, extravascular contrast agents. This results in higher signal
intensity, even when using a relatively low dose of the contrast agent.
Study objective
To study the feasiblity of cardiac MRI at 3T and the potential benefits of the
intravascular contrast agent gadofosveset for studying and quantifiaction of
heart function and -perfusion.
Study design
In this pilot study cardiac MRI at 1.5T and 3T will be compared. At 1.5T the
current clinical protocol will be used to detect wall motion disturbances,
abnormalities in perfusion and myocardial infarction. Within several weeks
after the first MRI, a similar study will be performed at 3T, but with adjusted
acquisition parameters compensating for higher field strength. Additionally,
wall motion sequences will be performed after administration of the contrast
agent gadofosveset.
Study burden and risks
MRI is a diagnostic tool with minimal burden for the patient. The use of
contrast agents is associated with minimal risks. However, side effects of MR
contrast agents are rare and, if they occur, they can generally be treated
well. In previous trials with Gadofosveset, this agent has demonstrated to be
useful and safe.
Peter Debijelaan 25
6229HX, Maastricht
NL
Peter Debijelaan 25
6229HX, Maastricht
NL
Listed location countries
Age
Inclusion criteria
scheduled cardiac MRI for suspected ischemic heart disease
age: > 18 years en < 90 years
informed consent
Exclusion criteria
severe cardiac rhythm disturbances
hemodynamic unstable
contra-indications for contrast-enhanced MRI: absolute: pacemaker, pacemakerwires, implanted hearing aid, cerebral vascular clips. Relative contra-indications: neurostimulator, insulinpump, metal corpora aliena, claustrophobic patients, pregnancy, previous reaction on MR contrast agents
age: <18 years en > 90 years
Design
Recruitment
Medical products/devices used
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 |
---|---|
EudraCT | EUCTR2006-004583-32-NL |
CCMO | NL14167.068.06 |