ANZCTR - Registration

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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]

Nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Stroke

Carotid atherosclerosis

Condition category

Condition code

Stroke

Ischaemic

Cardiovascular

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]

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]

FMISO uptake in carotid arteries

Timepoint [1]

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]

MRI black blood sequence

Timepoint [1]

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]

MRI 4D flow in carotid arteries

Timepoint [2]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW

Recruitment hospital [1]

Royal North Shore Hospital - St Leonards

Recruitment postcode(s) [1]

2065 - St Leonards

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Heart Research Australia

Address [1]

Level 4, Building 35
Royal North Shore Hospital
St Leonards
NSW 2065 · Australia

Country [1]

Australia

Funding source category [2]

University

Name [2]

The University of Sydney Medical School Foundation

Address [2]

Faculty of Medicine and Health
Rm 210, Edward Ford Building A27
The University of Sydney
NSW 2006

Country [2]

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]

None

Name [1]

N/A

Address [1]

N/A

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Northern Sydney Local Health District Human Research Ethics Committee

Ethics committee address [1]

 Level 13, Research Office, Kolling Building, Royal North Shore Hospital
 Pacific Highway
 St Leonards
 NSW 2065

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

09/12/2016

Ethics approval number [1]

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

Dr Paul Bonnitcha

Address

Level 12, Kolling Institute,
Royal North Shore Hospital,
St Leonards, NSW, 2065

Country

Australia

Phone

+61 2 99267111

Fax

paul.bonnitcha@sydney.edu.au

Contact person for public queries

Name

Paul Bonnitcha

Address

Level 12, Kolling Institute,
Royal North Shore Hospital,
St Leonards, NSW, 2065

Country

Australia

Phone

+61 2 99267111

Fax

paul.bonnitcha@sydney.edu.au

Contact person for scientific queries

Name

Paul Bonnitcha

Address

Level 12, Kolling Institute,
Royal North Shore Hospital,
St Leonards, NSW, 2065

Country

Australia

Phone

+61 2 99267111

Fax

paul.bonnitcha@sydney.edu.au

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 paul.bonnitcha@sydney.edu.au

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.

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