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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
Scientific title
A comparison of cerebrovascular compliance measures derived from trans-cranial Doppler and near-infrared imaging in healthy participants
Secondary ID [1] 296835 0
Nil known
Universal Trial Number (UTN)
Trial acronym
CIP (Cerebrovascular Imaging Project)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cerebrovascular health 310738 0
Condition category
Condition code
Neurological 309427 309427 0 0
Studies of the normal brain and nervous system

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
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.

Intervention code [1] 313117 0
Not applicable
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.
Control group
Active

Outcomes
Primary outcome [1] 308382 0
TCD measure of cerebral compliance, calculated using Doppler blood flow velocity and blood pressure data.
Timepoint [1] 308382 0
on the day of measurement, assessed continuously throughout 5 minutes of TCD recording
Primary outcome [2] 308383 0
NiRS measure of cerebral compliance, calculated using NiRS, ECG and blood pressure recordings
Timepoint [2] 308383 0
on the day of measurement, assessed continuously throughout 5 minutes of NiRS recording
Secondary outcome [1] 354817 0
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.
Timepoint [1] 354817 0
Assessed once based on the response to the questionnaire on the scan date

Eligibility
Key inclusion criteria
Healthy

General population who meet our minimum age limit and all exclusion criteria
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Severe head trauma, chronic psychiatric or neurological illness, claustrophobia, have ferromagnetic/metal implants, pregnant women, tinnitus

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Convenience sample
Timing
Prospective
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.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 25113 0
2305 - New Lambton Heights

Funding & Sponsors
Funding source category [1] 301409 0
University
Name [1] 301409 0
University of Newcastle
Address [1] 301409 0
University Dr, Callaghan NSW 2308, Australia
Country [1] 301409 0
Australia
Primary sponsor type
University
Name
University of Newcastle
Address
University Dr, Callaghan NSW 2308, Australia
Country
Australia
Secondary sponsor category [1] 301086 0
None
Name [1] 301086 0
Address [1] 301086 0
Country [1] 301086 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302144 0
The University of Newcastle Human Research Ethics Committee (HREC)
Ethics committee address [1] 302144 0
University Dr, Callaghan NSW 2308, Australia
Ethics committee country [1] 302144 0
Australia
Date submitted for ethics approval [1] 302144 0
01/11/2017
Approval date [1] 302144 0
22/02/2018
Ethics approval number [1] 302144 0
H-2017-0357

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
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 89270 0
Prof Sarah Johnson
Address 89270 0
University of Newcastle, University Dr, Callaghan NSW 2308
Country 89270 0
Australia
Phone 89270 0
+61 2 4921 6028
Fax 89270 0
Email 89270 0
sarah.johnson@newcastle.edu.au
Contact person for public queries
Name 89271 0
Mr Rashid Ghorbani Afkhami
Address 89271 0
University of Newcastle, University Dr, Callaghan NSW 2308
Country 89271 0
Australia
Phone 89271 0
+61 416359024
Fax 89271 0
Email 89271 0
rashid.ghorbaniafkhami@uon.edu.au
Contact person for scientific queries
Name 89272 0
Prof Sarah Johnson
Address 89272 0
University of Newcastle, University Dr, Callaghan NSW 2308
Country 89272 0
Australia
Phone 89272 0
+61 2 4921 6028
Fax 89272 0
Email 89272 0
sarah.johnson@newcastle.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?
All De-identified participant raw data in the form of text files will be shared.
When will data be available (start and end dates)?
Available for 2 years after publication
Available to whom?
researchers who provide a methodologically sound proposal
Available for what types of analyses?
No specific type
How or where can data be obtained?
Access subject to approvals by Principal Investigator
What supporting documents are/will be available?
Informed consent form
Ethical approval
Other
'Other' documents specified
Brief statistical analysis approach plan for the project
Methodological approach
CRF questionnaire
How or where can supporting documents be obtained?
Type [1] 677 0
Ethical approval
Citation [1] 677 0
Link [1] 677 0
Email [1] 677 0
Other [1] 677 0
Type [2] 679 0
Informed consent form
Citation [2] 679 0
Link [2] 679 0
Email [2] 679 0
Other [2] 679 0
Type [3] 1051 0
Other
Citation [3] 1051 0
Link [3] 1051 0
Email [3] 1051 0
Other [3] 1051 0
Methodological approach
Type [4] 1052 0
Other
Citation [4] 1052 0
Link [4] 1052 0
Email [4] 1052 0
Other [4] 1052 0
Brief statistical analysis approach plan for the project
Type [5] 1072 0
Other
Citation [5] 1072 0
Link [5] 1072 0
Email [5] 1072 0
Other [5] 1072 0
CRF Questionnaire
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary