- To detect carotid and aortic plaque morphology and long term plaque behaviour in patients with cerebral and cardiac end-organ damage (NSTEMI / STEMI and TIA / CVA) with 1.5T MRI-derived virtual histology and relation to biomarkers.- To correlateā¦
ID
Source
Brief title
Condition
- Coronary artery disorders
- Central nervous system vascular disorders
- Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- Comparison MRI based virtual histology of atherosclerotic plaques between
patient groups and plaque behaviour over time.
Secondary outcome
- Correlation between CEA specimen and MRI based virtual histology of carotid
plaque.
- Relation of biomarkers to plaque morphology and longitudinal behavior
- Feasibility testing of new high field MRI-sequences for
high-spatial-resolution vessel wall imaging of the aorta, carotid artery and
coronary arteries.
Background summary
- Acute coronary and cerebral vascular syndromes are caused by thrombus
formation in moderately stenosed arteries at the site of a ruptured or eroded
fibrous cap. Different atherosclerotic plaque morphology is suggested in
non-ST-elevation myocardial infarction (NSTEMI) versus ST-elevation myocardial
infarction (STEMI) and for Transient Ischemic Attack (TIA) versus Cerebro
Vascular Accident (CVA). It has also been suggested that TIA related plaques
show prolonged plaque instability compared to CVA related plaques. However,
these observations are based on limited data and validation to histological
specimen is scarce.
- Although, NSTEMI / STEMI and TIA / CVA have different end organs (heart and
brain respectively) comparable plaque morphology in coronary artery, aorta and
carotid artery and behaviour over time has been suggested.
- Magnetic Resonance Imaging (MRI) based virtual histology has the potential to
investigate the atherosclerosis in different larger vascular territories (i.e.
aorta, carotid) and to determine cerebral end organ damage in a non-invasive
fashion.
- Magnetic Resonance Imaging (MRI) based virtual histology at 1,5 Tesla is not
sufficient to determine plaque morphology in smaller vascular territories.
However, high field MRI (3T and 7T) bears the potential to assess plaque
morphology in smaller vascular territories such as the coronary arteries. This
enables further exploration of coronary atherosclerotic plaques and the
relation between plaques in different territories and end organs.
Study objective
- To detect carotid and aortic plaque morphology and long term plaque behaviour
in patients with cerebral and cardiac end-organ damage (NSTEMI / STEMI and TIA
/ CVA) with 1.5T MRI-derived virtual histology and relation to biomarkers.
- To correlate MRI atherosclerotic plaque virtual histology to histologic
specimen obtained in subgroup of patients undergoing CEA.
- To investigate plaque morphology and relation to cerebral end organ damage.
- To develop new high field MRI-sequences for high-spatial-resolution vessel
wall imaging of the aorta, carotid artery and coronary arteries to further
explore the relation between plaques in different territories and their end
organs.
Study design
- MRI vessel wall aortic arch, carotid arteries, and MRI cerebrum at baseline
and follow up (1 year).
- Histological assessment of Carotid End Arterectomy (CEA) specimen in subgroup
of patients undergoing CEA and correlation to MRI virtual histology.
- Baseline and follow up levels of biomarkers.
- Development of high field vessel wall imaging sequences
Study burden and risks
- When exclusion criteria are fulfilled the MRI is not harmful.
- For the patient there is no direct benefit related to participation.
Postbus 9600
2300 RC Leiden
NL
Postbus 9600
2300 RC Leiden
NL
Listed location countries
Age
Inclusion criteria
Patients with recent ( < 2 weeks) Cerebro Vascular Accident (CVA), Transient Ischemic Attack, ST-elevation Myocardial Infarction (STEMI), Non-ST-elevation Myocardial Infarction (NSTEMI)
Exclusion criteria
Contradication for MRI or Gadolinium based contrast agent
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 | NL31244.058.10 |