Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001682134
Ethics application status
Approved
Date submitted
21/11/2019
Date registered
2/12/2019
Date last updated
2/12/2019
Date data sharing statement initially provided
2/12/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Assessing cerebrovascular function using magnetic resonance imaging: A pilot study
Scientific title
Assessing cerebrovascular function in healthy individuals with MRI: A pilot study
Secondary ID [1] 299946 0
None
Universal Trial Number (UTN)
U1111-1241-3720
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dementia 315286 0
Condition category
Condition code
Neurological 313585 313585 0 0
Studies of the normal brain and nervous system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
MRI Safety Screening Form and Health Screening Questionnaire
Delivered by a trained investigator. Delivered face-to-face.
Delivered once. Takes 5-10 min to complete this paper form.

Measurement of cerebral blood flow and cerebral metabolic rate for oxygen using MRI
Assessed under baseline/resting conditions, and during neurovacular coupling and CO2 reactivity testing described below.
Delivered by a trained radiologist and investigator team. Delivered face-to-face.

Neurovascular coupling test in MRI scanner
Participants will view a black/white flickering radial checkerboard visual stimulus alternated with a neutral grey screen baseline.
Delivered by a trained radiologist and investigator team. Delivered face-to-face.
Delivered as 5 x ~30s exposures, separated by ~30 s.
Procedure conducted on a single occasion.

Cerebrovascular CO2 reactivity
Participants alternate between breathing room air and a premixed gas mixture with a mildly elevated partial pressure of CO2 (5% CO2, 21% O2, balance N2) via a Douglas bag (~2 min).
Delivered by a trained radiologist and investigator team. Delivered face-to-face.
Procedure conducted on a single occasion.

Cardiac MRI
Conventional ECG-gated retrospective cine cardiac MRI acquisitions will be acquired parallel and perpendicular to the cardiac long-axis.
Delivered by a trained radiologist and investigator team. Delivered face-to-face.
Delivered once. Takes ~15-20 min to complete.
Intervention code [1] 316139 0
Diagnosis / Prognosis
Comparator / control treatment
No control group. This is a pilot study which serves to help develop post-aquisition analysis methods.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 322039 0
Neurovascular coupling as assessed using a MRI scan.
Timepoint [1] 322039 0
Single timepoint of acquisition (i.e., at experimental session)
Secondary outcome [1] 377130 0
Cerebrovascular CO2 reactivity as assessed with a MRI scan.
Timepoint [1] 377130 0
Single timepoint of acquisition

Eligibility
Key inclusion criteria
• Healthy individuals
• Not taking any prescription or over-the-counter medications (other than oral contraceptive pill)
• Men and women
• Aged over 18 years
• Body mass index less than 30 kg/m2 (i.e. kilograms divided by height in metres squared)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
• Body mass index less than 18 kg/m2 (i.e. kilograms divided by height in metres squared)
• Smokers
• Alcohol intake > 28 units/week
• Users of recreational drugs
• Cardiovascular disease (e.g., coronary heart disease, hypertension)
• Significant arrhythmias (e.g., atrial fibrillation, previous VT / significant ventricular ectopy)
• Severe respiratory disease (e.g., chronic obstructive pulmonary disease)
• Metabolic disease (e.g., type II diabetes)
• Cancer
• Connective tissue or inflammatory disease
• Neurological or cerebrovascular disease
• Infection or pyrexial illness
• Thyroid disorders
• Hepatic or renal impairment
• Outside the stated age range
• Current pregnancy
• Underlying medical conditions, which in the opinion of the Investigator place the participant at unacceptably high risk for participating in the study
• Inability to fully or appropriately provide consent (e.g., language issue, reading capability)

Study design
Purpose of the study
Educational / counselling / training
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
Not yet recruiting
Date of first participant enrolment
Anticipated
2/12/2019
Actual
Date of last participant enrolment
Anticipated
6/07/2020
Actual
Date of last data collection
Anticipated
31/07/2020
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment outside Australia
Country [1] 22134 0
New Zealand
State/province [1] 22134 0
Auckland

Funding & Sponsors
Funding source category [1] 304334 0
University
Name [1] 304334 0
University of Auckland
Country [1] 304334 0
New Zealand
Primary sponsor type
University
Name
University of Auckland
Address
The University of Auckland
Office of Research Strategy and Integrity
Email: [email protected]
Private Bag 92019, Auckland 1142
Country
New Zealand
Secondary sponsor category [1] 304581 0
None
Name [1] 304581 0
Address [1] 304581 0
Country [1] 304581 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304785 0
Central Health and Disability Ethics Committee
Ethics committee address [1] 304785 0
Ethics committee country [1] 304785 0
New Zealand
Date submitted for ethics approval [1] 304785 0
10/10/2019
Approval date [1] 304785 0
08/11/2019
Ethics approval number [1] 304785 0
19/CEN/178

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 98194 0
A/Prof James P Fisher
Address 98194 0
Faculty of Medical and Health Sciences,
Department of Physiology,
University of Auckland | 85 Park Road, Grafton, Auckland 1023
Country 98194 0
New Zealand
Phone 98194 0
+64 09 373 7599
Fax 98194 0
Email 98194 0
[email protected]
Contact person for public queries
Name 98195 0
James P Fisher
Address 98195 0
Faculty of Medical and Health Sciences,
Department of Physiology,
University of Auckland | 85 Park Road, Grafton, Auckland 1023
Country 98195 0
New Zealand
Phone 98195 0
+64 09 373 7599
Fax 98195 0
Email 98195 0
[email protected]
Contact person for scientific queries
Name 98196 0
James P Fisher
Address 98196 0
Faculty of Medical and Health Sciences,
Department of Physiology,
University of Auckland | 85 Park Road, Grafton, Auckland 1023
Country 98196 0
New Zealand
Phone 98196 0
+64 09 373 7599
Fax 98196 0
Email 98196 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.