PET-MRI Imaging in Patients With Symptomatic Carotid Artery Stenosis

Sponsor

University of Edinburgh (Other)

Overall Status

Completed

CT.gov ID

NCT03215550

Collaborator

(none)

Enrollment

Location

26.9

Actual Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Stroke Carotid Stenosis	Procedure: CEA Radiation: 18F PET-MRI Diagnostic Test: Transcranial Doppler

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 Design

Study Type:

Observational

Actual Enrollment :

20 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Oct 12, 2017

Actual Primary Completion Date :

Jan 10, 2020

Actual Study Completion Date :

Jan 10, 2020

Arms and Interventions

Arm	Intervention/Treatment
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.	Procedure: CEA Carotid Endarterectomy Radiation: 18F PET-MRI 18F-fluoride Hybrid PET-MRI Diagnostic Test: Transcranial Doppler Microembolic Signals detection

Arm

Intervention/Treatment

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.

Procedure: CEA

Carotid Endarterectomy

Radiation: 18F PET-MRI

18F-fluoride Hybrid PET-MRI

Diagnostic Test: Transcranial Doppler

Microembolic Signals detection

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centre for Cardiovascular Science	Edinburgh		United Kingdom	EH16 4SB

Sponsors and Collaborators

University of Edinburgh

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Edinburgh

ClinicalTrials.gov Identifier:

NCT03215550

Other Study ID Numbers:

AC17046

First Posted:

Jul 12, 2017

Last Update Posted:

Feb 11, 2020

Last Verified:

Feb 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by University of Edinburgh

atherosclerosis, imaging

Additional relevant MeSH terms:

Carotid Stenosis

Constriction, Pathologic

Study Results

No Results Posted as of Feb 11, 2020