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PET-MRI Imaging in Patients With Symptomatic Carotid Artery Stenosis

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ClinicalTrials.gov Identifier: NCT03215550
Recruitment Status : Completed
First Posted : July 12, 2017
Last Update Posted : February 11, 2020
Sponsor:
Information provided by (Responsible Party):
University of Edinburgh

Tracking Information
First Submitted Date June 14, 2017
First Posted Date July 12, 2017
Last Update Posted Date February 11, 2020
Actual Study Start Date October 12, 2017
Actual Primary Completion Date January 10, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 10, 2017)
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title PET-MRI Imaging in Patients With Symptomatic Carotid Artery Stenosis
Official Title Hybrid 18F-fluoride Positron Emission Tomography-Magnetic Resonance Imaging in Patients With Symptomatic Carotid Artery Stenosis
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
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.
Sampling Method Non-Probability Sample
Study Population 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.
Condition
  • Stroke
  • Carotid Stenosis
Intervention
  • Procedure: CEA
    Carotid Endarterectomy
  • Radiation: 18F PET-MRI
    18F-fluoride Hybrid PET-MRI
  • Diagnostic Test: Transcranial Doppler
    Microembolic Signals detection
Study Groups/Cohorts 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:
  • Procedure: CEA
  • Radiation: 18F PET-MRI
  • Diagnostic Test: Transcranial Doppler
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: February 10, 2020)
20
Original Estimated Enrollment
 (submitted: July 10, 2017)
40
Actual Study Completion Date January 10, 2020
Actual Primary Completion Date January 10, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 40 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number NCT03215550
Other Study ID Numbers AC17046
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party University of Edinburgh
Study Sponsor University of Edinburgh
Collaborators Not Provided
Investigators Not Provided
PRS Account University of Edinburgh
Verification Date February 2020