StrokeNCT03215550
PET-MRI Imaging in Patients With Symptomatic Carotid Artery Stenosis
An observational study of Stroke and Carotid Stenosis, run by University of Edinburgh at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Stroke, Carotid Stenosis
- What is being tested?
- CEA, 18F PET-MRI and Transcranial Doppler
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 12 Oct 2017to 10 Jan 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Patients with carotid artery stenosis (>50% for men and >70% for women, by NASCET criteria) above 40 years of age.
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Centre for Cardiovascular Science
Edinburgh, EH16 4SB
About this study
Official title: Hybrid 18F-fluoride Positron Emission Tomography-Magnetic Resonance 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.
Read the 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.
- Conditions
- Stroke, Carotid Stenosis
- Being tested
- CEA, 18F PET-MRI, Transcranial Doppler
- Keywords
- atherosclerosis, imaging
- Medical subject headings
- Stroke, Carotid Stenosis, Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CEAProcedure or surgery
Carotid Endarterectomy
18F PET-MRIRadiation
18F-fluoride Hybrid PET-MRI
Transcranial DopplerDiagnostic test
Microembolic Signals detection
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: CEA; Radiation: 18F PET-MRI; Diagnostic Test: Transcranial Doppler |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2017
- Study start12 Oct 2017
- Primary completion10 Jan 2020
- Study completion10 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by University of EdinburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Edinburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03215550
- Sponsor's protocol ID
- AC17046
- Status last verified
- Feb 2020
- First submitted
- 14 Jun 2017
- Last updated
- 11 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35670715
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hybrid 18F-fluoride Positron Emission Tomography-Magnetic Resonance Imaging in Patients With Symptomatic Carotid Artery Stenosis
- ClinicalTrials.gov ID
- NCT03215550
- Acronym / sponsor ID
- AC17046
- Conditions
- Stroke, Carotid Stenosis
- Keywords
- atherosclerosis, imaging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of EdinburghUniversity, hospital or other
- Study start
- 12 Oct 2017 (actual)
- Primary completion
- 10 Jan 2020 (actual)
- Study completion
- 10 Jan 2020 (actual)
- First posted
- 12 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Carotid Endarterectomy | – | Procedure: CEA, Radiation: 18F PET-MRI, Diagnostic Test: Transcranial DopplerPatients 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. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Patients with carotid artery stenosis (>50% for men and >70% for women, by NASCET criteria) above 40 years of age.
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CEACarotid Endarterectomy | Procedure or surgery | Carotid Endarterectomy |
| 18F PET-MRI18F-fluoride Hybrid PET-MRI | Radiation | Carotid Endarterectomy |
| Transcranial DopplerMicroembolic Signals detection | Diagnostic test | Carotid Endarterectomy |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2020.
- Derived from this study: PubMed 35670715Kaczynski 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke and Carotid Stenosis, run by University of Edinburgh at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
18F-fluoride uptake in the culprit plaque in carotid, aortic and intra-cranial vessels. (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03215550, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2020.