Atherosclerosis Clinical Trial
Official title:
Morphological and Serological Criteria of Plaque Vulnerability: Risk Assessment for Symptomatic and Asymptomatic Carotid Artery Stenosis
The aim of this study is to investigate the association of sonographic and histological features of the plaque among each other and with biomarkers of cardiovascular risk. The predictive value of these factors concerning the long-term clinical outcome after carotid endarterectomy will also be assessed. This may help to improve the identification of patients with carotid artery stenosis who will benefit most from carotid endarterectomy. The investigators major hypothesis is that the morphology of carotid plaques is associated with objectifiable sonographic parameters, in particular with the greyscale median. Second, the investigators hypothesize that sonographic and histological plaque morphology are associated with certain biomarkers of cardiovascular risk. Identification of 'vulnerable plaques' on the basis of a peripheral blood draw and a sonographic investigation may enable the treating physician to focus resources on patients who will benefit most form therapeutic interventions for primary prevention of ischemic stroke.
The indication for revascularization of carotid artery stenoses is typically based on the
degree of stenosis and the presence of symptoms. Recent evidence suggests that the risk of
embolization from an atherosclerotic plaque may be associated with plaque density as
assessed sonographically by determination of the greyscale median. Also, an association of
serum proteins vascular endothelial growth factor (VEGF), hypoxia inducible factor (HIF) and
pigment epithelium-derived factor (PEDF), matrix metalloproteinases 2, 8 and 9 with unstable
plaques has been reported.
The VUCAP study will include patients undergoing carotid endarterectomy for symptomatic or
asymptomatic carotid artery disease. Sonographic and serological markers of plaque
vulnerability will be compared with histological features of the plaque and clinical
presentation (symptomatic vs. asymptomatic). Preoperatively, the greyscale median of the
plaque is assessed. Histomorphological investigation of the carotid plaques will be
performed. Serological investigations will include markers of inflammation,
thrombo-modulatory factors, lipid fractions and other parameters that have been associated
with unstable plaques.
The aim of the present study is to assess the ability of pigment epithelium-derived factor
(PEDF), vascular endothelial growth factor (VEGF), hypoxia-induced factor 1 alpha (HIF 1-α),
matrix metalloproteinases 2, 8 and 9 to differentiate between vulnerable and stable carotid
artery plaques. Identification of 'vulnerable plaques' on the basis of a peripheral blood
draw and a sonographic investigation may enable the treating physician to focus resources on
patients who will benefit most form therapeutic interventions for primary prevention of
ischemic stroke.
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Observational Model: Case-Only, Time Perspective: Prospective
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