ANZCTR - Registration

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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

Trial registered on ANZCTR

Registration number

ACTRN12617001210369

Ethics application status

Approved

Date submitted

15/08/2017

Date registered

18/08/2017

Date last updated

5/04/2023

Date data sharing statement initially provided

5/04/2023

Type of registration

Prospectively registered

Titles & IDs

Public title

Does cerebral perfusion impact on cognitive function following intervention for carotid artery stenosis?

Scientific title

Does cerebral perfusion impact on cognitive function following intervention for carotid artery stenosis?

Secondary ID [1]

Nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

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

carotid artery stenosis

cognition

Condition category

Condition code

Cardiovascular

Diseases of the vasculature and circulation including the lymphatic system

Mental Health

Studies of normal psychology, cognitive function and behaviour

Intervention/exposure

Study type

Observational

Patient registry

False

Target follow-up duration

Target follow-up type

Description of intervention(s) / exposure

Cerebral perfusion (as measured by cerebral blood flow on transcranial doppler, cerebral oximetry on near-infrared spectroscopy, and magnetic resonance imaging with arterial spin labelling protocols and diffusion weighted imaging), and cognitive function (as measured by CogState, DKEFS Verbal Fluency test, and Stroop test) will be measured pre-intervention/1 week post-intervention/4 weeks post-intervention/3 months post-intervention in patients who undergo either carotid endarterectomy for high-grade carotid artery stenoses for stroke risk reduction (under current algorithms and evidence for carotid intervention). Cerebrovascular reserve as per Ringelstein calculations will also be measured pre-intervention/4 weeks post-intervention/3 months post-intervention using hypocapnic (baseline minus 6mmHg EtCO2), room air, 3% CO2 inhalation, and 6% CO2 inhalation.

Intervention code [1]

Not applicable

Comparator / control treatment

Healthy age and education matched subjects with or without out high-grade carotid stenoses will undergo the above listed measurements at 4 time points equivalent to those undergoing carotid intervention - baseline measurement (equivalent to pre-intervention), 1-2 weeks post-baseline (equivalent to 1 week post-intervention), 4-6 weeks post-baseline (equivalent to 4 weeks post-intervention), and 3-4 months post-baseline (equivalent to 3 months post-intervention).

Control group

Active

Outcomes

Primary outcome [1]

Cognitive function as measured by CogState battery, DKEFS Verbal Fluency test, Stroop test; measured as a composite.

Timepoint [1]

Pre-intervention (approx 1 week pre), 1 week post-intervention, 4 weeks post-intervention, 3 months post-intervention

Primary outcome [2]

Cerebral perfusion as measured by MRI arterial spin labelled protocol

Timepoint [2]

Pre-intervention (approx 1 week pre), 1 week post-intervention

Primary outcome [3]

Cerebrovascular reactivity as measured by transcranial doppler of middle cerebral artery flows, with four stimuli (hypocapnic ie baseline minus 6mmHg EtCO2, baseline at room air, 3% CO2, 6% CO2), calculated as per Ringelstein's equation.

Timepoint [3]

Pre-intervention (approx 1 week pre), 1 week post-intervention, 4 weeks post-intervention, 3 months post-intervention

Secondary outcome [1]

Quality of life as measured by WHO-QOL questionnaire

Timepoint [1]

Pre-intervention, 1 week post-intervention, 4 weeks post-intervention, 3 months post-intervention.

Secondary outcome [2]

Mood as measured by POMS-A questionnaire, administered immediately prior to cognitive testing

Timepoint [2]

Pre-intervention, 1 week post-intervention, 4 weeks post-intervention, 3 months post-intervention.

Eligibility

Key inclusion criteria

Patients 45-89 years of age planned for carotid endarterectomy or carotid artery stenting of high-grade carotid stenoses for stroke risk reduction.
Healthy control group: 45-89 years of age, age and education matched volunteers/spouses.

Minimum age

45 Years

Maximum age

89 Years

Sex

Both males and females

Can healthy volunteers participate?

Yes

Key exclusion criteria

Non-English speaking
Functional impairment impeding physical ability to participate in cognitive testing
Diagnosed dementia
Haemorrhagic stroke
Stroke post-operatively
On neuro-modulating drugs

Study design

Purpose

Natural history

Duration

Longitudinal

Selection

Defined population

Timing

Prospective

Statistical methods / analysis

Generalised linear mixed model

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

18/08/2017

Actual

18/08/2017

Date of last participant enrolment

Anticipated

31/10/2019

Actual

31/10/2019

Date of last data collection

Anticipated

31/01/2020

Actual

10/01/2020

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Recruitment hospital [1]

Sir Charles Gairdner Hospital - Nedlands

Recruitment hospital [2]

St John of God Hospital, Subiaco - Subiaco

Recruitment hospital [3]

Mount Hospital - Perth

Recruitment postcode(s) [1]

6009 - Nedlands

Recruitment postcode(s) [2]

6008 - Subiaco

Recruitment postcode(s) [3]

6000 - Perth

Funding & Sponsors

Funding source category [1]

Other Collaborative groups

Name [1]

Heart Research Institute

Address [1]

Harry Perkins Institute of Medical Research Level 2, QQ block, Queen Elizabeth II Medical Campus 6 Verdun Street Nedlands WA 6009

Country [1]

Australia

Funding source category [2]

Hospital

Name [2]

Sir Charles Gairdner Hospital

Address [2]

Hospital Avenue Nedlands WA 6009

Country [2]

Australia

Funding source category [3]

University

Name [3]

School of Science (Exercise and Sports Science), University of Western Australia

Address [3]

35 Stirling Highway Crawley WA 6009

Country [3]

Australia

Funding source category [4]

Commercial sector/Industry

Name [4]

WL Gore & Associates

Address [4]

Suite 1 13a Narabang Way Belrose, NSW 2085

Country [4]

Australia

Funding source category [5]

Commercial sector/Industry

Name [5]

Boston Scientific

Address [5]

Building 1, L6 Connect Corporate Centre, 191 O’Riordan Street, Mascot, NSW 2020

Country [5]

Australia

Funding source category [6]

Commercial sector/Industry

Name [6]

Abbott Medical

Address [6]

Abbott Vascular 299 Lane Cove Road Macquarie Park, NSW 2113

Country [6]

Australia

Funding source category [7]

University

Name [7]

Curtin University

Address [7]

Kent Street, Bentley, Perth, Western Australia 6102

Country [7]

Australia

Primary sponsor type

Individual

Name

Dr Shirley Jansen

Address

Dept of Vascular and Endovascular Surgery
Sir Charles Gairdner Hospital
Hospital Avenue
Nedlands, Perth
WA 6009

Country

Australia

Secondary sponsor category [1]

Individual

Name [1]

Dr Chi Ho Ricky Kwok

Address [1]

Dept of Vascular and Endovascular Surgery Sir Charles Gairdner Hospital Hospital Avenue Nedlands, Perth WA 6009

Country [1]

Australia

Secondary sponsor category [2]

Individual

Name [2]

Winthrop Professor Daniel Green

Address [2]

School of Science (Exercise and Sports Science) University of Western Australia (M408) 35 Stirling Highway Crawley, Perth Western Australia 6009

Country [2]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Human Research Ethics Committee, Sir Charles Gairdner Hospital

Ethics committee address [1]

Sir Charles Gairdner Hospital
Level 2, A Block, Hospital Avenue, NEDLANDS WA 6009

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

30/11/2014

Approval date [1]

11/02/2015

Ethics approval number [1]

RGS0000001708

Summary

Brief summary

The link between carotid artery disease and stroke is well defined in severe carotid artery stenosis. The link between carotid artery disease, cerebral perfusion, and cognitive function, is less well characterised, particularly in the absence of clinical stroke. Characterising the relationship between carotid stenosis, cerebral perfusion, and cognitive function is relevant to 1). understanding the role of carotid intervention in improving cerebral perfusion and cognitive function and, thereby, dementia prevention; 2). reconsidering the threshold for intervention in those patients who are judged ‘asymptomatic’ by current criteria (whereby indications for intervention are based on stroke risk reduction); and 3). examining whether the two distinct forms of intervention for carotid stenosis (carotid endarterectomy and carotid artery stenting) have different impacts on cognitive function. Alongside our study of the impact of intervention for carotid stenosis and cognition, we will also examine relationships between changes in cognition and quality of life. If improvement in cerebral perfusion and cognitive function in patients treated for asymptomatic carotid artery stenosis can be demonstrated, this would impact significantly on decision making and treatment for these patients with respect to the prevention of cognitive decline.

The overarching aim of this research is to determine whether changes in cognitive function occur in older adults following intervention for carotid artery stenosis.

The primary objectives are to investigate whether:
1) carotid endarterectomy (CEA) improves cognitive function in patients with symptomatic and asymptomatic carotid artery stenosis,
2) changes in cognitive function following CEA are related to changes in cerebral blood flow and cerebrovascular reserve (CVR) in patients with symptomatic and asymptomatic carotid artery stenosis,
4) changes in cognitive function following CEA are related to findings on MRI, and specifically, on arterial spin-labelled cerebral perfusion imaging,
5) changes in cognitive function following CEA are independent of changes in mood scores,
6) changes in cognitive function following CEA are related to changes in quality of life.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Chi Ho Ricky Kwok

Address

Dept of Vascular and Endovascular Surgery Sir Charles Gairdner Hospital Hospital Ave Nedlands WA 6009

Country

Australia

Phone

+61 8 6457 3333

Fax

+61 8 6457 2298

[email protected]

Contact person for public queries

Name

Ricky Kwok

Address

Dept of Vascular and Endovascular Surgery Sir Charles Gairdner Hospital Hospital Ave Nedlands WA 6009

Country

Australia

Phone

+61 8 6457 3333

Fax

+61 8 6457 2298

[email protected]

Contact person for scientific queries

Name

Ricky Kwok

Address

Dept of Vascular and Endovascular Surgery Sir Charles Gairdner Hospital Hospital Ave Nedlands WA 6009

Country

Australia

Phone

+61 8 6457 3333

Fax

+61 8 6457 2298

[email protected]

Data sharing statement

Will the study consider sharing individual participant data?

Yes

Will there be any conditions when requesting access to individual participant data?

Persons/groups eligible to request access:
• Upon request with a sound proposal, as determined by primary sponsor

Conditions for requesting access:
• -

What individual participant data might be shared?

• deidentified cognitive and perfusion data

What types of analyses could be done with individual participant data?

• To achieve aims of approved proposal

When can requests for individual participant data be made (start and end dates)?

From:
From publication until Jan 2027.

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?

• Request initially via email [email protected]

Are there extra considerations when requesting access to individual participant data?

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.

Trial Review

Documents added manually

Documents added automatically