Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001021167
Ethics application status
Approved
Date submitted
23/04/2019
Date registered
16/07/2019
Date last updated
13/07/2021
Date data sharing statement initially provided
16/07/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Examining the difference between stroke patients and asymptomatic patients with carotid atherosclerosis
Scientific title
Assessment of Carotid Atherosclerotic plaques in stroke patients and asymptomatic patients using FMISO-PET Scans
Secondary ID [1] 298028 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 312482 0
Carotid atherosclerosis 312483 0
Condition category
Condition code
Stroke 311028 311028 0 0
Ischaemic
Cardiovascular 311825 311825 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 314259 0
Diagnosis / Prognosis
Comparator / control treatment
Patients who have carotid atherosclerosis but have not had any strokes or transient ischaemic attacks
Control group
Active

Outcomes
Primary outcome [1] 319830 0
FMISO uptake in carotid arteries
Timepoint [1] 319830 0
For those who have had an ischaemic event, the PET scan will take place 2-14 days after ischaemic event. The scan can occur on different day to the MRI scan and there is no time limit between scans provided both are completed within 14 days to the ischaemic event.

The FMISO uptake is assessed in both patients arms (both those who have and those who have not had an ischaemic event)
Secondary outcome [1] 371818 0
MRI black blood sequence
Timepoint [1] 371818 0
For those who have had an ischaemic event, the MRI scan will take place 2-14 days after ischaemic event. The scan can occur on different day to the PET scan and there is no time limit between scans provided both are completed within 14 days to the ischaemic event.

The MRI scan is assessed in both patients arms (both those who have and those who have not had an ischaemic event)
Secondary outcome [2] 371819 0
MRI 4D flow in carotid arteries
Timepoint [2] 371819 0
The MRI blood flow in carotids will take place at the same time as the MRI black blood sequence scan

Eligibility
Key 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
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
No data analysis planned
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
Actual
1/08/2019
Date of last participant enrolment
Anticipated
1/12/2021
Actual
12/02/2021
Date of last data collection
Anticipated
1/12/2021
Actual
12/02/2021
Sample size
Target
20
Accrual to date
Final
2
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 13646 0
Royal North Shore Hospital - St Leonards
Recruitment postcode(s) [1] 26322 0
2065 - St Leonards

Funding & Sponsors
Funding source category [1] 302557 0
Charities/Societies/Foundations
Name [1] 302557 0
Heart Research Australia
Country [1] 302557 0
Australia
Funding source category [2] 302559 0
University
Name [2] 302559 0
The University of Sydney Medical School Foundation
Country [2] 302559 0
Australia
Primary sponsor type
Hospital
Name
Royal North Shore Hospital
Address
Level 13, Research Office
Kolling Building, Royal North Shore Hospital
Pacific Highway
St Leonards NSW 2065
Country
Australia
Secondary sponsor category [1] 303208 0
None
Name [1] 303208 0
N/A
Address [1] 303208 0
N/A
Country [1] 303208 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303201 0
Northern Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 303201 0
Level 13, Research Office, Kolling Building, Royal North Shore Hospital
Pacific Highway
St Leonards
NSW 2065
Ethics committee country [1] 303201 0
Australia
Date submitted for ethics approval [1] 303201 0
Approval date [1] 303201 0
09/12/2016
Ethics approval number [1] 303201 0
RESP/16/216

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 92834 0
Dr Paul Bonnitcha
Address 92834 0
Level 12, Kolling Institute,
Royal North Shore Hospital,
St Leonards, NSW, 2065
Country 92834 0
Australia
Phone 92834 0
+61 2 99267111
Fax 92834 0
Email 92834 0
[email protected]
Contact person for public queries
Name 92835 0
Dr Paul Bonnitcha
Address 92835 0
Level 12, Kolling Institute,
Royal North Shore Hospital,
St Leonards, NSW, 2065
Country 92835 0
Australia
Phone 92835 0
+61 2 99267111
Fax 92835 0
Email 92835 0
[email protected]
Contact person for scientific queries
Name 92836 0
Dr Paul Bonnitcha
Address 92836 0
Level 12, Kolling Institute,
Royal North Shore Hospital,
St Leonards, NSW, 2065
Country 92836 0
Australia
Phone 92836 0
+61 2 99267111
Fax 92836 0
Email 92836 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Processed scan results from the study (PET and MRI) and the corresponding de-identified patients
When will data be available (start and end dates)?
Data will be available from the 9th December 2021 until the 9th of December 2031
Available to whom?
Individuals will be able to access the deidentified research data on request to the principal investigator
Available for what types of analyses?
No restriction
How or where can data be obtained?
By contacting the principal investigator on [email protected]


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.