NCT03215563|Completed
PET-MRI Imaging in Patients With Acute Neurovascular Syndrome
Hybrid 18F-Fluoride Positron Emission Tomography-Magnetic Resonance Imaging in Patients With Acute Acute Neurovascular Syndrome
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Hybrid 18F-Fluoride Positron Emission Tomography-Magnetic Resonance Imaging in Patients With Acute Acute Neurovascular Syndrome
Sponsor study identifier
observational
80
1 country
1
Study Start
October 12, 2017
Actual (reported)Primary Completion
January 10, 2020
Actual (reported)Study Completion
January 10, 2020
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 10, 2020
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 14, 2017
Actual (reported)July 12, 2017
Actual (reported)October 12, 2017
Actual (reported)January 10, 2020
Actual (reported)January 10, 2020
Actual (reported)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.
2 weeks
Patients with carotid artery stenosis who either do not meet surgical criteria (\< 50% by NASCET criteria for men, \<70% for women), or meet criteria but do not undergo surgery (surgery declined or not offered) and are currently treated with OMT. This cohort will be recruited from the acute TIA clinics and Vascular Laboratory logbooks at Edinburgh Royal Infirmary and Western General Hospital.
Patients with an atherosclerotic disease in the aortic arch including origins of its major branches other than the internal carotid artery treated with OMT. Patients with a cardiac source of embolism will be excluded from the study. This group will be recruited from the acute TIA clinics and inpatients at Edinburgh Royal Infirmary and Western General Hospital.
18F-fluoride Hybrid PET-MRI
Microembolic Signals detection
Two cohorts of 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.
Centre for Cardiovascular Science
Edinburgh, EH16 4SB, United Kingdom
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.
80 participants (actual enrollment reported by the registry).
First Submitted
June 14, 2017
First Posted
July 12, 2017
Study Start
October 12, 2017
Actual (reported)Impact of Verticalization on Intracranial Hemodynamics Assessed in Transcranial Doppler at the Acute Phase of Cerebral Infarction
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Primary Completion
January 10, 2020
Actual (reported)Study Completion
January 10, 2020
Actual (reported)Last Updated
February 11, 2020
Record last verified: 2020-02
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Source: ClinicalTrials.gov.
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