PET-MRI Imaging in Patients With Symptomatic Carotid Artery Stenosis

Completed

• Conditions: Carotid Stenosis; Stroke
• Interventions: Procedure: CEA; Radiation: 18F PET-MRI; Diagnostic Test: Transcranial Doppler

• Registration Number: NCT03215550
• Lead Sponsor: University of Edinburgh

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.

Detailed Description

The ability to identify the culprit carotid plaque represents a key goal in carotid artery imaging. Although an array of non-invasive imaging techniques can detect a wide spectrum of complementary high-risk characteristics, no single modality can reliably identify vulnerable plaques associated with future stroke development. Substantial histological data suggests that specific plaque components identify patients at high-risk for future ipsilateral stroke and cardiovascular events. This implies that investigators need to look beyond the traditional paradigm where the basis for carotid endarterectomy were formulated by an invasive imaging modality that provided no information on the arterial wall composition. Alternative imaging strategies are therefore required targeting not only in vivo carotid morphology but also plaque biology and disease activity. This is fundamental to optimal risk-stratification and appropriate selection of patients for high-risk vascular intervention. One new approach is to use non-invasive molecular imaging targeted at plaque biology using hybrid systems such as positron emission tomography-magnetic resonance imaging.

Study Timeline

• Study First Submitted: 2017-06-14
• Study First Submitted QC: 2017-07-10
• Study First Posted: 2017-07-12
• Study Start: 2017-10-12
• Primary Completion: 2020-01-10
• Study Completion: 2020-01-10
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-10
• Last Update Posted: 2020-02-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Carotid Endarterectomy	CEA	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.
Carotid Endarterectomy	18F PET-MRI	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.
Carotid Endarterectomy	Transcranial Doppler	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.

Primary Outcome Measures

Name	Time	Method
18F-fluoride uptake in the culprit plaque in carotid, aortic and intra-cranial vessels.	2 weeks	18F-fluoride uptake will be measured by the mean and max Standardised Uptake Values (SUV) derived from the culprit atherosclerotic plaques.

Trial Locations

Locations (1)

Centre for Cardiovascular Science; 🇬🇧 Edinburgh, United Kingdom