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: humanethics@auckland.ac.nz
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
Health and Disability Ethics Committees
Ministry of Health
133 Molesworth Street
PO Box 5013
Wellington
6011
0800 4 ETHICS
hdecs@health.govt.nz
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
The brain has a high metabolic rate and it is therefore important that local blood flow is closely matched to brain cell activation and metabolism (neurovascular coupling), and that brain blood flow increases to limit build up of metabolic waste products, such as carbon dioxide (cerebrovascular CO2 reactivity). The aim of this project is to conduct pilot studies to establish state-of-the-art methods for assessing neurovascular coupling and cerebrovascular CO2 reactivity within the Centre for Advanced Magnetic Resonance Imaging (CAMRI) at the University of Auckland. These studies will provide a foundation for future work investigating cerebrovascular dysfunction in clinical populations.
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
jp.fisher@auckland.ac.nz
Contact person for public queries
Name 98195 0
A/Prof 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
jp.fisher@auckland.ac.nz
Contact person for scientific queries
Name 98196 0
A/Prof 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
jp.fisher@auckland.ac.nz

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.