Stroke Clinical Trial
Official title:
Hybrid 18F-fluoride Positron Emission Tomography-Magnetic Resonance Imaging in Patients With Symptomatic Carotid Artery Stenosis
NCT number | NCT03215550 |
Other study ID # | AC17046 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | October 12, 2017 |
Est. completion date | January 10, 2020 |
Verified date | February 2020 |
Source | University of Edinburgh |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Ischaemic stroke is a major cause of death and disability worldwide. In patients with recent stroke, the 18F-fluoride positron emission tomography-computed tomography highlights high-risk culprit carotid plaque and is more discriminatory than 18F-fluorodeoxyglucose. Using hybrid positron emission tomography-magnetic resonance imaging investigators propose to build upon these findings by prospectively assessing 18F-fluoride uptake in a broad range of patients with acute transient ischaemic attack or ischaemic stroke. Investigators will specifically examine the association of 18F-fluoride uptake with multiparametric magnetic resonance imaging assessments of atherosclerotic plaque, especially the role of thrombus and lipid. Finally, using transcranial Doppler and diffusion-weighted magnetic resonance brain imaging, an assessment of the functional consequences of 18F-fluoride-positive atherosclerotic plaque will be performed. If successful, this technique has a number of valuable translational applications including the better selection of patients for carotid intervention.
Status | Completed |
Enrollment | 20 |
Est. completion date | January 10, 2020 |
Est. primary completion date | January 10, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years and older |
Eligibility |
Inclusion Criteria: • Patients with carotid artery stenosis (>50% for men and >70% for women, by NASCET criteria) above 40 years of age. Exclusion Criteria: - Patients with new stroke and a modified Rankin score >3 - Chronic kidney disease with an estimated Glomerular Filtration Rate (eGFR) of <30 ml/min/1.73 m2 - Atrial fibrillation - Pregnant women - Prior ipsilateral carotid intervention - Prior neck radiotherapy - Inability to tolerate the supine position - Participation in the study would result in delay to surgery - Psychiatric illness/social situations that would limit compliance with study requirements - History of allergic reaction attributed to 18F-fluoride - History of allergic reaction to gadolinium contrast media - Metal implants and devices including pacemakers and defibrillators |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Centre for Cardiovascular Science | Edinburgh |
Lead Sponsor | Collaborator |
---|---|
University of Edinburgh |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 18F-fluoride uptake in the culprit plaque in carotid, aortic and intra-cranial vessels. | 18F-fluoride uptake will be measured by the mean and max Standardised Uptake Values (SUV) derived from the culprit atherosclerotic plaques. | 2 weeks |
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