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Examining the difference between stroke patients and asymptomatic patients with carotid atherosclerosis

Assessment of Carotid Atherosclerotic plaques in stroke patients and asymptomatic patients using FMISO-PET Scans

Status
Terminated
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12619001021167
Enrollment
2
Registered
2019-07-16
Start date
2019-08-01
Completion date
2021-02-12
Last updated
2021-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Atherosclerotic plaques are a major contributor to ischaemic strokes. While magnetic resonance imaging (MRI), duplex ultrasonography, computer tomography (CT) and angiographic investigations can detect atherosclerosis, there is currently no method to accurately determine which plaques are most likely to cause clinical events, or alternatively, which plaques are stable. Identifying “vulnerable” plaques, irrespective of the degree of stenosis, is therefore a key aim of vascular researchers. It is suggested that vulnerable plaques have a higher degree of hypoxia than asymptomatic plaques. FMISO is a tracer known to accumulated in hypoxic regions. The proposed project is a pilot study that aims to utilize FMISO for carotid artery imaging to determine whether it can distinguish between vulnerable and stable plaques This study will recruit patients at Royal North Shore Hospital who have had previous stroke and undertake FMISO PET scans of their carotid arteries. It will compare them to PET images from patients who have plaque but who have not had ischaemic events in order to ascertain whether positive PET scans correlate with symptomatic plaques compared to negative controls who have no history of TIA.

Interventions

FMISO PET/CT scan of head and neck (30 minute scan). 250 MBq of FMISO is given intravenously 90 minutes before the scan by the medical radiation scientist. MRI scan of head and neck (40 minutes) with intravenous contrast (gadolinium) given at time of scan by the radiolographer All participants will have both scans unless there is a specific contraindication. There is no set duration between scans and they can take place on different days however, for patients who have had stroke (the symptomati

FMISO PET/CT scan of head and neck (30 minute scan). 250 MBq of FMISO is given intravenously 90 minutes before the scan by the medical radiation scientist. MRI scan of head and neck (40 minutes) with intravenous contrast (gadolinium) given at time of scan by the radiolographer All participants will have both scans unless there is a specific contraindication. There is no set duration between scans and they can take place on different days however, for patients who have had stroke (the symptomatic arm), the aim is to undertake both scans within 14 days of the initial event.

Sponsors

Royal North Shore Hospital
Lead SponsorHospital

Study design

Allocation
Non-randomised trial
Primary purpose
Diagnosis

Eligibility

Sex/Gender
All
Age
50 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Male or female patients > 50 years of age; AND 2. Carotid plaque unilaterally or bilaterally resulting in internal carotid artery stenosis >50% on duplex ultrasonography AND 3. Either a) A Previous stroke or transient ischaemic attack (TIA) in the vascular territory of all affected internal carotid arteries OR b) Previous stroke or transient ischaemic attack in the vascular territory of the one affected internal carotid artery OR c) No previous stroke or transient ischaemic attack in the vascular territory of any internal carotid arteries

Exclusion criteria

1. Pregnancy or breast-feeding; 2. Inability to lie in a supine position on the PET scanning bed for 15 minutes; 3. Subjects who required sedation for their baseline clinical PET/CT scan; 4. Renal failure requiring haemo- or peritoneal dialysis; 5. Substance abuse, medical, psychological or social conditions that in the opinion of the investigator may interfere with the patient’s participation in the study or evaluation of the study results; 6. Atrial fibrillation or known cardiogenic cause of stroke 7. Recent vascular surgery or intervention surgery

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026