The aims of the study are the following:1. to study the prevalence of coronary and aortic atherosclerosis assessed using 3 Tesla MRI 2. to study rate of change in coronary and aortic atherosclerosis measurements assessed using 3 Tesla MR imaging3.…
ID
Source
Brief title
Condition
- Coronary artery disorders
- Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1 .Prevalence and distribution of coronary and aortic atherosclerosis
The prevalence of atherosclerosis is defined as the total number of
atherosclerotic lesions in the coronary arteries and aorta on the baseline 3T
MRI scan.
2. Progression (rate of changes) in coronary and aortic atherosclerosis
Progression in atherosclerosis can express itself as an increase in the total
number of atherosclerotic lesions, geometric measures or the proportion of the
vessel wall area occupied by various plaque components. In this study all three
variables of atherosclerosis will be used to assess the progression of
atherosclerosis.
3. Coronary and aortic atherosclerosis to predict future events
The baseline MRI scan will be used to predict future events. With respect to
future events, information will be collected concerning non fatal and fatal
vascular disease with clear definition.
Secondary outcome
-
Background summary
Despite considerable progress over last decades, cardiovascular disease remains
the leading cause of morbidity and mortality worldwide with the most serious
outcome being myocardial infarction, stroke and death. Magnetic Resonance
Imaging (MRI) is one of the imaging techniques that can detect atherosclerotic
lesions that are present years before a symptomatic cardiovascular events
occurs. Yet, little is known about the prevalence and distribution of aortic
and coronary atherosclerosis in patients with symptoms of non-coronary origin.
Furthermore, before the use in clinic practice the incremental predictive value
of coronary and aortic 3 Tesla MRI in predicting future cardiovascular events
over current used methods to assess risk has to be established.
Study objective
The aims of the study are the following:
1. to study the prevalence of coronary and aortic atherosclerosis assessed
using 3 Tesla MRI
2. to study rate of change in coronary and aortic atherosclerosis measurements
assessed using 3 Tesla MR imaging
3. to study the ability of coronary and aortic atherosclerosis to predict
future events on top of established risk prediction models
Study design
The study is designed as a single center cohort study with a cross-sectional
and a longitudinal part with repeated MRI scans and event follow up. The MRI
scans will be performed on a 3 Tesla MRI with a state of the art MRI protocol.
In 24 months all patients will undergo four MRI scan of the coronary arteries
and the aorta. The baseline MRI scan will be used to assess the prevalence and
distribution of atherosclerosis. The baseline MRI scan combined with the
clinical follow-up will determine the predictive value of the various
MRI-derived plaque volumes. The MRI scans at 6, 12 and 24 months will be used
to study the rate of changes in coronary and aortic MRI-derived plaque
volumes.
Study burden and risks
Magnetic Resonance Imaging has the advantage of not using and is able to image
atherosclerotic plaque components. For any risks associated with the use of
contrast (gadolinium) all necessary precaution will be taken (see E7/E9). In
two years, all patients will undergo four MRI scans of the coronary arteries
and aorta. This extent of burden and the minimal risks of participation is
justified given the importance of improved diagnosis in patients with
atherosclerosis and the possibility of improved diagnosis and treatment in the
future.
Heidelberglaan 100
Utrecht 3508 AA
NL
Heidelberglaan 100
Utrecht 3508 AA
NL
Listed location countries
Age
Inclusion criteria
- 18 years or older
- Patients with coronary artery disease, Transient Ischemic Attack (TIA), minor ischemic stroke, abdominal aortic aneurysm, peripheral arterial disease, presenting with symptoms suggestive of an acute coronary syndrome (ACS) and asymptomatic patients with an increased cardiovascular risk.
Exclusion criteria
- pregnancy or possible pregnancy
- documented allergic reaction to godalinium
- patients with impaired renal fuction (GFR < 30ml/min/1.73m2)
- impossibility to undergo MRI (determined by using the standard contradictions 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 | NL31637.041.11 |