Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000896370
Ethics application status
Approved
Date submitted
8/06/2017
Date registered
19/06/2017
Date last updated
16/05/2019
Date data sharing statement initially provided
16/05/2019
Date results provided
16/05/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Assessment of neurovascular function and cognition in adult patients with complex congenital heart disease
Scientific title
Assessment of neurovascular function and cognition in adult patients with complex congenital heart disease
Secondary ID [1] 292154 0
Nil known
Universal Trial Number (UTN)
U1111-1197-6721
Trial acronym
CoCo Heart Disease
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart disease 303593 0
Condition category
Condition code
Cardiovascular 303003 303003 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The study will examine cerebrovascular and cognitive function in patients with complex congenital heart disease and age-gender matched controls, using transcranial Doppler (TCD) ultrasound. The procedure will take up to 3 hours and will be performed by Dr Rachel Wong, the study coordinator, in week one. There is only one visit in this study.
Volunteers will be required to attend the Clinical Nutrition Research Centre (CNRC) for screening. If they are eligible, data collection for our outcome assessments will continue at the same visit.
Anthropometric measurements of height, weight and waist circumference will be obtained before clinic blood pressure is assessed to determine compliance with the study’s blood pressure criteria.
Participants will then be fitted with a headpiece supporting an ultrasound probe on each temporal region. An investigator will adjust the probes until a measurable blood flow signal is obtained in each middle cerebral artery (MCA). If the investigator is unable to obtain a blood flow signal in both MCAs, the participant will be excluded from the study. Otherwise, the participant will be assessed. The ultrasound will continuously record the changes in blood flow velocities in the MCA during a cognitive test battery.
After the cognitive test, the investigator will adjust the ultrasound probes to locate the posterior cerebral arteries [either the posterior cerebral arteries (PCA) or the basilar artery (BA)] on either side of the temporal window. Once a suitable blood flow signal is located, participant will be asked to open and close their eyes as guided by the investigator. Participants will not be excluded if blood flow signals from the posterior arteries are not found.
A walking test will be administered as the last assessment.
Intervention code [1] 298299 0
Not applicable
Comparator / control treatment
Healthy age-gender matched controls with no history of heart disease.
There is no intervention, observation only.
Control group
Active

Outcomes
Primary outcome [1] 302376 0
Cerebrovascular responsiveness (CVR) to cognitive testing at the level of the middle cerebral artery (MCA).
Using TCD ultrasound, changes in blood flow velocity in the MCA during cognitive testing will be measured.
Timepoint [1] 302376 0
Week 1, one visit only.
Secondary outcome [1] 335770 0
CVR to photic stimulation.
CVR to photic stimulation (neurovascular coupling) at the level of the posterior cerebral artery (PCA; posterior circulation) will be assessed using TCD ultrasound.
We will measure the increase in blood flow in the posterior cerebral artery (PCA) in response to photic stimulation. Blood flow velocities will be recorded continuously during two continuous cycles of 20-sec of checkered board stimulus, followed by 20-sec of eyes shut. This will be repeated after a 5-min interval.
Timepoint [1] 335770 0
Week 1, one visit only.
Secondary outcome [2] 335771 0
Basal cerebrovascular hemodynamics.
Transcranial doppler (TCD) ultrasound will be used to assess the cerebrovascular hemodynamics in the MCA and PCA.
Timepoint [2] 335771 0
Week 1, one visit only.
Secondary outcome [3] 335772 0
Cognitive performance.
Composite outcome: The testing battery will consist of the National Institute of Health (NIH) Toolbox battery of cognitive function, and additional testing of executive function (Trail Making Task) and working memory (N-back Test and Spatial Span Test).
Timepoint [3] 335772 0
Week 1, one visit only.
Secondary outcome [4] 335773 0
Gait speed.
Gait speed will be measured using the 4-metre walk test. Participants will be asked to walk at their normal walking speed in an open hallway, marked at a distance of 4 metres. Trials will be timed with a stop watch.
Timepoint [4] 335773 0
Week 1, one visit only.
Secondary outcome [5] 336072 0
Gait speed.
Gait speed will be measured using the 20-metre walk test. Participants will be asked to walk at their normal walking speed in an open hallway, marked at a distance of 20 metres. Trials will be timed with a stop watch.
Timepoint [5] 336072 0
Week 1. one visit only.

Eligibility
Key inclusion criteria
Adult patients with complex congenital heart disease, having measurable ultrasound signal on both sides of the head. Control participants should be healthy and without heart disease.
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Unable to obtain a measurable signal in both left and right MCA
History of cerebrovascular events, including transient ischemic attack.
Uncontrolled hypertension (>160/100mmHg) (measured at the visit to CNRC)
Pregnant women and people highly dependent on medical care.

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Case control
Timing
Prospective
Statistical methods / analysis
Participant characteristics (body mass index, waist circumference, clinic BP, medication use, history of sleep apnoea or myocardial infarction) will be used as covariates. Age and gender may be added as covariates if they are significantly correlated with the outcome measures. Echocardiography and cross sectional imaging (CT/MRI aorta), where available, will be assessed.
Participant characteristics will be used as covariates if they are significantly correlated with the outcome measures. A two-sample t-test will be used to compare the group differences in outcome measures. Linear regressions will determine if there are relationships between gait speed and cerebrovascular function and cognitive performance. Where appropriate, Bonferroni adjustments will be made to allow for multiple comparisons.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/07/2017
Actual
7/08/2017
Date of last participant enrolment
Anticipated
31/07/2018
Actual
4/05/2018
Date of last data collection
Anticipated
31/07/2018
Actual
4/05/2018
Sample size
Target
30
Accrual to date
Final
24
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 8317 0
John Hunter Hospital - New Lambton
Recruitment postcode(s) [1] 16381 0
2305 - New Lambton

Funding & Sponsors
Funding source category [1] 296689 0
Charities/Societies/Foundations
Name [1] 296689 0
John Hunter Hospital Charitable Trust
Country [1] 296689 0
Australia
Primary sponsor type
Individual
Name
Dr Nicholas Collins
Address
Nicholas Collins
Staff Specialist Cardiologist
John Hunter Hospital
Lookout Road.
New Lambton 2305 NSW
Country
Australia
Secondary sponsor category [1] 295648 0
Individual
Name [1] 295648 0
Dr Rachel Wong
Address [1] 295648 0
Clinical Nutrition Research Centre
University of Newcastle
School of Biomedical Sciences & Pharmacy
Medical Sciences Building, MS 514
Callaghan, NSW 2308
Country [1] 295648 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297914 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 297914 0
Ethics committee country [1] 297914 0
Australia
Date submitted for ethics approval [1] 297914 0
03/04/2017
Approval date [1] 297914 0
22/05/2017
Ethics approval number [1] 297914 0
17/04/12/4.01
Ethics committee name [2] 297915 0
University of Newcastle Human Research Ethics Committee
Ethics committee address [2] 297915 0
Ethics committee country [2] 297915 0
Australia
Date submitted for ethics approval [2] 297915 0
25/05/2017
Approval date [2] 297915 0
Ethics approval number [2] 297915 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 1781 1781 0 0
/AnzctrAttachments/373098-1704124.01 Ongoing Approval Single-site LeadHREC.pdf (Ethics approval)
Attachments [2] 1782 1782 0 0
/AnzctrAttachments/373098-CoCo Heart Disease Protocol (V1.1) RW final.docx (Protocol)
Attachments [3] 1783 1783 0 0
/AnzctrAttachments/373098-CoCo Heart Disease (information_sheet) version 1.1 RW final.docx (Participant information/consent)

Contacts
Principal investigator
Name 75450 0
Dr Nicholas Collins
Address 75450 0
Staff Specialist Cardiologist
John Hunter Hospital
c/- 58 Cleary Street
Hamilton NSW 2303
Country 75450 0
Australia
Phone 75450 0
+61 411 987 025
Fax 75450 0
Email 75450 0
Nicholas.Collins@hnehealth.nsw.gov.au
Contact person for public queries
Name 75451 0
Nicholas Collins
Address 75451 0
Staff Specialist Cardiologist
John Hunter Hospital
c/- 58 Cleary Street
Hamilton NSW 2303
Country 75451 0
Australia
Phone 75451 0
+61 411 987 025
Fax 75451 0
Email 75451 0
Nicholas.Collins@hnehealth.nsw.gov.au
Contact person for scientific queries
Name 75452 0
Rachel Wong
Address 75452 0
Clinical Nutrition Research Centre
University of Newcastle
School of Biomedical Sciences & Pharmacy
Medical Sciences Building, MS 514
Callaghan NSW 2308
Country 75452 0
Australia
Phone 75452 0
+61 2 4921 6408
Fax 75452 0
Email 75452 0
Rachel.Wong@newcastle.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
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.