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OpenTrials
Completed

NCT Number: NCT03215550

PET-MRI Imaging in Patients With Symptomatic Carotid Artery Stenosis

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.

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Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre for Cardiovascular Science

Edinburgh, EH16 4SB, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CEA

Procedure

Carotid Endarterectomy

18F PET-MRI

Radiation

18F-fluoride Hybrid PET-MRI

Transcranial Doppler

Diagnostic Test

Microembolic Signals detection

Primary outcomes

  1. 18F-fluoride uptake in the culprit plaque in carotid, aortic and intra-cranial vessels.

    Time frame: 2 weeks

    18F-fluoride uptake will be measured by the mean and max Standardised Uptake Values (SUV) derived from the culprit atherosclerotic plaques.

Sponsors and collaborators

Lead sponsor

University of Edinburgh

Other

Registry information

Official study title

Hybrid 18F-fluoride Positron Emission Tomography-Magnetic Resonance Imaging in Patients With Symptomatic Carotid Artery Stenosis

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Jul 12, 2017
Registry last updated
Feb 11, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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