An observational study in Atherosclerosis, Stroke and Transient Ischemic Attack, sponsored by University of Cambridge. Completed at 1 site in United Kingdom. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2016-08-24.
Sponsored by University of Cambridge · Observational
This VISION study aims to investigate the role of inflammation in atherosclerosis using 68Ga- DOTATATE PET, and to validate 68Ga-DOTATATE PET imaging for the detection and quantification of vascular inflammation in the aorta, coronary and carotid arteries. This study will test the hypothesis that in subjects undergoing carotid endarterectomy for symptomatic plaques, there will be a positive correlation between carotid artery 68Ga-DOTATATE PET signal and the underlying degree of carotid inflammation measured by immunohistochemical analysis.
Clinical events in atherosclerosis are largely driven by inflammation. Molecular imaging of atherosclerosis can potentially identify high-risk lesions, help guide treatment and illuminate the underlying biology of the disease. 18F-fluorodeoxyglucose (18F-FDG) PET is the gold-standard nuclear molecular imaging technique with well-established roles in atherosclerosis imaging. However, the arterial 18F-FDG signal is non-specific, although it is related to increased macrophage activity with contributions from hypoxia and angiogenesis. Coronary artery imaging with 18F-FDG is particularly difficult, mainly due to high background myocardial cell 18F-FDG uptake, which obscures interpretation of the coronary signal. Efforts to suppress myocardial 18F-FDG uptake with dietary manipulation are challenging for patients and have limited efficacy.
PET tracers currently used in cancer imaging, such as 68Ga-DOTATATE, are potentially more specific for inflammation and also lack myocardial muscle uptake. 68Ga-DOTATATE might therefore be better suited than 18F-FDG for imaging inflammation, particularly within the coronary arteries. The VISION study is a prospective, observational study designed to investigate the biology of plaque inflammation in atherosclerosis, using PET imaging with the somatostatin receptor ligand 68Ga-DOTATATE. 50 subjects with atherosclerosis will undergo sequential PET/CT imaging with 68Ga-DOTATATE and 18F-FDG, along with contrast angiography of the carotid and coronary arteries. Autoradiography and immunohistochemistry of excised carotid plaques will be used to validate the imaging data. If successful, 68Ga-DOTATATE imaging will offer a cheaper, more specific non-invasive measure of inflammation than 18F- FDG, particularly in the coronary arteries. This opens up the possibility of better risk stratification for patients with atherosclerosis and could provide a non-invasive platform to test the effects of novel anti-atherosclerosis drugs.
293 studies on the registry are indexed under Ischemic Attack, Transient; 64 are open to participants now.
This study's enrollment of 42 is below the median of 333 across 120 observational studies indexed under Ischemic Attack, Transient.
Browse Ischemic Attack, Transient studies →University of Cambridge is the lead sponsor of 112 studies on the registry; 23 are open to participants now.
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The study will recruit participants with recent transient ischaemic attack or stroke due to carotid artery disease, from which they have made a good functional recovery. A proportion of these patients will undergo carotid endarterectmy as part of clinical management. We will also recruit participants with asymptomatic carotid atheroma, and those with stable coronary artery disease or recent acute coronary syndrome.
Exclusion Criteria:
Participants with symptomatic or asymptomatic carotid artery plaques
Participants with stable coronary artery disease or recent acute coronary syndrome
Correlation of 68Ga-DOTATATE PET signal to carotid plaque inflammation
This primary outcome measure is correlation between carotid artery 68Ga-DOTATATE PET signal (TBR) and the underlying degree of carotid inflammation, measured by CD68 immunohistochemistry, in patients undergoing carotid endarterectomy.
Time frame: Baseline
Comparison of 68Ga-DOTATATE signal between symptomatic and asymptomatic carotid plaques
Time frame: Baseline (<1 month from event)
Correlation of carotid artery and coronary artery 68Ga-DOTATATE uptake
Time frame: Baseline
Correlation of Framingham Cardiovascular Risk Scores to arterial 68Ga-DOTATATE uptake
Time frame: Baseline
Correlation between carotid artery 68Ga-DOTATATE autoradiographic signal and degree of carotid inflammation, measured by CD68 immunohistochemistry
Time frame: Baseline
Comparison of myocardial 68Ga-DOTATATE and 18F-FDG uptake
Time frame: Baseline (2 scans within 1 week)
This study is completed, as verified in Aug 2016. You cannot join it, but the record below documents what was studied.
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University of Cambridge