PET-MRI Imaging in Patients With Symptomatic Carotid Artery Stenosis
Hybrid 18F-fluoride Positron Emission Tomography-Magnetic Resonance Imaging in Patients With Symptomatic Carotid Artery Stenosis
1 other identifier
observational
20
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Oct 2017
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 14, 2017
CompletedFirst Posted
Study publicly available on registry
July 12, 2017
CompletedStudy Start
First participant enrolled
October 12, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 10, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
January 10, 2020
CompletedFebruary 11, 2020
February 1, 2020
2.2 years
June 14, 2017
February 10, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
Carotid Endarterectomy
Patients who are scheduled to undergo carotid endarterectomy for symptomatic carotid artery stenosis (≥50% by NASCET criteria for men, ≥70% for women) who are above 40 years of age.
Interventions
Eligibility Criteria
Patients with evidence of an acute stroke, transient ischaemic attack or amaurosis fugax will be recruited as early as possible, but within 14 days of symptom onset. All patients will undergo careful clinical evaluation including carotid Doppler ultrasound assessment and magnetic resonance imaging of the brain. This cohort will be identified at the point they are referred to a vascular surgeon at Edinburgh Royal Infirmary.
You may qualify if:
- Patients with carotid artery stenosis (\>50% for men and \>70% for women, by NASCET criteria) above 40 years of age.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Centre for Cardiovascular Science
Edinburgh, EH16 4SB, United Kingdom
Related Publications (1)
Kaczynski J, Sellers S, Seidman MA, Syed M, Dennis M, Mcnaught G, Jansen M, Semple SI, Alcaide-Corral C, Tavares AAS, MacGillivray T, Debono S, Forsythe R, Tambyraja A, Slomka PJ, Leipsic J, Dweck MR, Whiteley W, Wardlaw J, van Beek EJR, Newby DE, Williams MC. 18F-NaF PET/MRI for Detection of Carotid Atheroma in Acute Neurovascular Syndrome. Radiology. 2022 Oct;305(1):137-148. doi: 10.1148/radiol.212283. Epub 2022 Jun 7.
PMID: 35670715DERIVED
Biospecimen
At the time of carotid endarterectomy, which is an established surgical intervention aimed at reducing the future risk of stroke in symptomatic patients, tissue will be collected, and lesion integrity and geometry will be preserved as much as possible. Specimens will be photographed in detail to permit subsequent assessment by independent and blinded reviewers. The excised tissue will be aligned and labelled to permit orientation in the carotid artery axis before undertaking 7.4 T magnetic resonance spectroscopy. Subsequently, carotid plaque will be snap frozen in liquid nitrogen. Cellular content, macrophage infiltration, apoptosis, and calcification-associated molecules within the plaques will be assessed by RNA analysis, immunohistochemistry and immunofluorescence using a variety of validated markers.
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 14, 2017
First Posted
July 12, 2017
Study Start
October 12, 2017
Primary Completion
January 10, 2020
Study Completion
January 10, 2020
Last Updated
February 11, 2020
Record last verified: 2020-02
Data Sharing
- IPD Sharing
- Will not share