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Trial registered on ANZCTR
Registration number
ACTRN12619000144112
Ethics application status
Approved
Date submitted
8/01/2019
Date registered
30/01/2019
Date last updated
13/03/2019
Date data sharing statement initially provided
30/01/2019
Date results information initially provided
13/03/2019
Type of registration
Retrospectively registered
Titles & IDs
Public title
Investigating brain health using non-invasive imaging
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Scientific title
A comparison of cerebrovascular compliance measures derived from trans-cranial Doppler and near-infrared imaging in healthy participants
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Secondary ID [1]
296835
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Nil known
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Universal Trial Number (UTN)
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Trial acronym
CIP (Cerebrovascular Imaging Project)
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Cerebrovascular health
310738
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Condition category
Condition code
Neurological
309427
309427
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0
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Studies of the normal brain and nervous system
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Intervention/exposure
Study type
Observational
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Patient registry
False
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Observed – Cerebrovascular blood flow and peripheral blood pressure and ECG waves. Two observation methods of Cerebrovascular blood flow over two days of observation. Transcranial Doppler (TCD) and Near-infrared spectroscopy (NiRS)
In the first imaging session, all subjects will undergo 60 minutes of NiRS imaging.
After the setup process, the NiRS data will be collected during 5 minutes of resting state of sitting position. During NIRS recordings subjects will wear a non-invasive chest strap containing an EquivitalTM EQ02 LifeMonitor to monitor respiration, heart beat.
After the NIRS session, subjects will be asked to answer a questionnaire about their daily activity and their height and weight will be measured to assess their cardiorespiratory fitness.
In the second imaging session, the transcranial Doppler device will be used to measure blood flow in middle cerebral arteries. Once a steady-state cerebral blood flow velocity is achieved, a 5-minute beat-to-beat recording will be obtained with blood pressure measured 3 times during this interval.
The two imaging sessions will be carried out on 2 consecutive days. For each subject, the NiRS imaging will take place at Hunter medical research institute imaging centre for a total of one hour. The TCD imaging will take place at the Clinical Nutrition Research Centre at the University of Newcastle’s Callaghan campus for one hour.
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Intervention code [1]
313117
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Not applicable
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Comparator / control treatment
Doppler will be the comparator test as sophisticated compliance estimators have already been developed for ultrasound blood flow velocity measurements and TCD is regarded as the ground truth for compliance estimation.
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Control group
Active
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Outcomes
Primary outcome [1]
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TCD measure of cerebral compliance, calculated using Doppler blood flow velocity and blood pressure data.
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Assessment method [1]
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Timepoint [1]
308382
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on the day of measurement, assessed continuously throughout 5 minutes of TCD recording
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Primary outcome [2]
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NiRS measure of cerebral compliance, calculated using NiRS, ECG and blood pressure recordings
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Assessment method [2]
308383
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Timepoint [2]
308383
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on the day of measurement, assessed continuously throughout 5 minutes of NiRS recording
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Secondary outcome [1]
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Cardiorespiratory fitness (CRF) measure will be calculated using the Jurca's Questionnaire, which asks for the participant's level of physical activity and uses weight, height and gender information to estimate CRF.
The method and the questionnaire are developed by Jurca et.al. in "Assessing Cardiorespiratory Fitness Without Performing Exercise Testing" published in the American Journal of Preventive Medicine.
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Assessment method [1]
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Timepoint [1]
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Assessed once based on the response to the questionnaire on the scan date
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Eligibility
Key inclusion criteria
Healthy
General population who meet our minimum age limit and all exclusion criteria
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
Severe head trauma, chronic psychiatric or neurological illness, claustrophobia, have ferromagnetic/metal implants, pregnant women, tinnitus
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Study design
Purpose
Natural history
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Duration
Cross-sectional
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Selection
Convenience sample
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Timing
Prospective
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Statistical methods / analysis
Our primary measure will be a comparison of NIRS and TCD. Published comparisons of NIRS and TCD on blood flow related measures show correlation with effect sizes, r, reported between 0.49 and 0.62. Given an expected effect size at the average of r=0.55, the number of samples required to achieve significance at the p=0.01 level is n=34. Even at the lowest correlation coefficient, r= 0.49, n=30 is sufficient to obtain significance at the p=0.05 level.
To buffer against any other dropouts we will recruit n=35 participants.
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
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Actual
10/07/2018
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Date of last participant enrolment
Anticipated
1/03/2019
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Actual
5/03/2019
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Date of last data collection
Anticipated
15/03/2019
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Actual
13/03/2019
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Sample size
Target
35
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Accrual to date
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Final
38
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment postcode(s) [1]
25113
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2305 - New Lambton Heights
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Funding & Sponsors
Funding source category [1]
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University
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Name [1]
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University of Newcastle
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Address [1]
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University Dr, Callaghan NSW 2308, Australia
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Country [1]
301409
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Australia
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Primary sponsor type
University
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Name
University of Newcastle
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Address
University Dr, Callaghan NSW 2308, Australia
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
301086
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Address [1]
301086
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Country [1]
301086
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
302144
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The University of Newcastle Human Research Ethics Committee (HREC)
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Ethics committee address [1]
302144
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University Dr, Callaghan NSW 2308, Australia
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Ethics committee country [1]
302144
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Australia
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Date submitted for ethics approval [1]
302144
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01/11/2017
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Approval date [1]
302144
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22/02/2018
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Ethics approval number [1]
302144
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H-2017-0357
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Summary
Brief summary
The primary purpose of our study is to compare Near-infrared spectroscopy and Transcranial Doppler in terms of measuring cerebrovascular elasticity. Our hypothesis is that NiRS results will have a significant correlation with TCD-derived elasticity measurements
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Prof Sarah Johnson
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Address
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University of Newcastle, University Dr, Callaghan NSW 2308
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Country
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Australia
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Phone
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+61 2 4921 6028
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Mr Rashid Ghorbani Afkhami
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Address
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University of Newcastle, University Dr, Callaghan NSW 2308
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Country
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Australia
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Phone
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+61 416359024
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Fax
89271
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Email
89271
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[email protected]
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Contact person for scientific queries
Name
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Prof Sarah Johnson
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Address
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University of Newcastle, University Dr, Callaghan NSW 2308
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Country
89272
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Australia
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Phone
89272
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+61 2 4921 6028
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Fax
89272
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Email
89272
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
All De-identified participant raw data in the form of text files will be shared.
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When will data be available (start and end dates)?
Available for 2 years after publication
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Available to whom?
researchers who provide a methodologically sound proposal
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Available for what types of analyses?
No specific type
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How or where can data be obtained?
Access subject to approvals by Principal Investigator
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What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
677
Ethical approval
376553-(Uploaded-10-12-2018-13-27-30)-Study-related document.pdf
679
Informed consent form
376553-(Uploaded-10-12-2018-13-28-07)-Study-related document.pdf
1051
Other
Methodological approach
376553-(Uploaded-14-01-2019-15-01-33)-Study-related document.pdf
1052
Other
Brief statistical analysis approach plan for the p...
[
More Details
]
376553-(Uploaded-14-01-2019-15-04-54)-Study-related document.pdf
1072
Other
CRF Questionnaire
376553-(Uploaded-16-01-2019-11-03-39)-Study-related document.pdf
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
Source
Title
Year of Publication
DOI
Dimensions AI
Indexing cerebrovascular health using near-infrared spectroscopy
2021
https://doi.org/10.1038/s41598-021-94348-5
Dimensions AI
Indexing Cerebrovascular Health Using Transcranial Doppler Ultrasound
2021
https://doi.org/10.1016/j.ultrasmedbio.2020.12.022
N.B. These documents automatically identified may not have been verified by the study sponsor.
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