PET-MRI Imaging in Patients With Acute Neurovascular Syndrome

NCT03215563 | Completed

• 1 other identifier: AC17058
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; Carotid Stenosis

Keywords

atherosclerosis, imaging

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Carotid

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.

Radiation: 18F PET-MRI; Diagnostic Test: Transcranial Doppler

Non Carotid

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.

Radiation: 18F PET-MRI; Diagnostic Test: Transcranial Doppler

Interventions

18F PET-MRI RADIATION

18F-fluoride Hybrid PET-MRI

Carotid; Non Carotid

Transcranial Doppler DIAGNOSTIC_TEST

Microembolic Signals detection

Carotid; Non Carotid

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• Patients above 40 years of age with carotid artery stenosis that do not achieve criteria for CEA (\<50% for men, \<70% for women, by NASCET criteria) or the patient has declined CEA.
• Patients above 40 years of age with atherosclerotic disease of aortic arch and its branches.

You may not qualify if:

• 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 or devices including pacemakers and defibrillators

Sponsors & Collaborators

• University of Edinburgh: lead

Study Sites (1)

Centre for Cardiovascular Science

Edinburgh, EH16 4SB, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 35670715 DERIVED

MeSH Terms

Conditions

Stroke; Carotid Stenosis; Atherosclerosis

Interventions

Ultrasonography, Doppler, Transcranial

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Carotid Artery Diseases; Arterial Occlusive Diseases; Arteriosclerosis

Intervention Hierarchy (Ancestors)

Echoencephalography; Neuroradiography; Neuroimaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Radiography; Ultrasonography; Ultrasonography, Doppler; Diagnostic Techniques, Neurological; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2017
• First Posted: July 12, 2017
• Study Start: October 12, 2017
• Primary Completion: January 10, 2020
• Study Completion: January 10, 2020
• Last Updated: February 11, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)