Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001327279
Ethics application status
Approved
Date submitted
29/06/2018
Date registered
7/08/2018
Date last updated
10/07/2019
Date data sharing statement initially provided
26/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Using Molecular Plaque Imaging to Ascertain Cardiovascular Risk in Patients with Sleep Apnoea
Scientific title
Using Molecular Plaque Imaging to Ascertain Cardiovascular Risk in Patients with Sleep Apnoea
Secondary ID [1] 295327 0
None
Universal Trial Number (UTN)
Trial acronym
SLEEP-PLAQUE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atherosclerotic Cardiovascular Disease 308526 0
Sleep Apnoea 308527 0
Condition category
Condition code
Cardiovascular 307495 307495 0 0
Coronary heart disease
Respiratory 307496 307496 0 0
Sleep apnoea

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Patients with moderate to severe (based on a clinically indicated PSG) OSA: (AHI greater than 15) and either high symptom load (ESS greater than 10 or self-reported falling asleep accident/near miss accident in the last 6 months) or resistant hypertension (elevated BP despite at least 3 agents) requiring CPAP will participate in this study. A PET-CT will be performed following intravenous administration of 18F-fluorodeoxyglucose (FDG) on the PET-CT scanner at the Clinical Research Imaging Centre (CRIC), which is capable of vascular imaging of the aorta and carotid arteries. Patients will be asked not to participate in any vigorous exercise 24 hours prior to study, and to fast between 6 and 8 hours before being scanned. Blood glucose will be checked by finger-stick measurement before 18F-FDG injections. Patients with a pre-scan glucose level not within 2.5-10mmol/L will be excluded from the study. 18F-FDG (5 MBq/kg) will be injected intravenously, and patients will rest for 90 minutes prior to scan. Scan will take about 60 minutes.
Intervention code [1] 312077 0
Not applicable
Comparator / control treatment
Patients with mild (based on a clinically indicated PSG) OSA (AHI less than 15) not requiring CPAP and both minimal symptoms (ESS less than 10 and no self-reported falling asleep accident/near miss accident in the last 6 months) and lack of resistant hypertension

Control group
Active

Outcomes
Primary outcome [1] 306468 0
ascertain the presence of inflammatory activity of atherosclerotic plaque in atherosclerotic cardiovascular disease patients with OSA.

Arterial FDG uptake will be measured using target-to- background ratio (TBR) calculations of the carotid arteries and thoracic aorta. TBRmean and TBRmax scores will be calculated for all ROIs (regions of interest) to make quantitative assessments of plaque inflammation in the carotid arteries and descending thoracic aorta.
Timepoint [1] 306468 0
baseline
Secondary outcome [1] 350311 0
ascertain the extent of inflammatory activity of atherosclerotic plaque in atherosclerotic cardiovascular disease patients with OSA

Arterial FDG uptake will be measured using target-to- background ratio (TBR) calculations of the carotid arteries and thoracic aorta. TBRmean and TBRmax scores will be calculated for all ROIs (regions of interest) to make quantitative assessments of plaque inflammation in the carotid arteries and descending thoracic aorta.
Timepoint [1] 350311 0
baseline

Eligibility
Key inclusion criteria
a. Able to provide written, informed consent
b. Age greater than or equal to 40 years of age
c. Evidence of established atherosclerotic cardiovascular disease
As evident by
i. History of myocardial infarction
ii. acute coronary syndrome
iii. arterial revascularization
OR
Risk Factor (One Required)
i. Cigarette smoking current?
ii. Hypertension (BP greater than or equal to 140/90 mm Hg or current use of antihypertensive medication)?
iii. Diabetes mellitus
iv. Low HDL cholesterol (men less than 1.0 mmol/l; women less than 1.3 mmol/l)
v. Family history of premature CHD (in first-degree male relative less than 55 years of age; in first-degree female relative less than 65 years of age
vi. Age (men: 50 years or older; women: 55 years or older)?
vii. hs-CRP greater than or equal to 2 mg/L
d. OSA diagnosed by polysomnography (PSG) with diagnosis that fits one of the two options below
I. AHI greater than 15 and either high symptom load (ESS greater than 10 or self-reported falling asleep accident/near miss accident in the last 6 months) or resistant hypertension (elevated BP despite at least 3 agents) requiring CPAP
II. AHI less than 15 not requiring CPAP and both minimal symptoms (ESS less than 10 and no self-reported falling asleep accident/near miss accident in the last 6 months) and lack of resistant hypertension
e. Treated with a stable dose of statin therapy for 4 weeks or more (dose can be zero)
Minimum age
40 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
a. Inability to provide written, informed consent
b. Unwilling to undergo PET-CT imaging
c. Treated with chronic anti-inflammatory agents (immunosuppressants, oral corticosteroids)
d. Chronic kidney disease (use of dialysis or eGRF <50 mL/min)
e. Subjects with uncontrolled diabetes defined as HbA1c > 13 % in the last 3 months
f. insulin treatment for diabetes mellitus
g. Systemic inflammatory or autoimmune disease
h. Prior aortic or carotid surgery
i. Prior use of CPAP for OSA in the last 12 months
j. Female participants cannot be pregnant or breast-feeding

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Arterial FDG uptake will be measured using target-to- background ratio (TBR) calculations along the axial segments of the carotid arteries and thoracic aorta. TBRmean and TBRmax scores will be calculated for all ROIs (regions of interest) to make quantitative assessments of plaque inflammation in the carotid arteries and descending thoracic aorta. The sample size of 25 patients in each group will enable us to calculate the sample size for further study. Continuous variables will be reported as mean ± SD and categorical variables as counts and percentages.

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Other reasons/comments
Other reasons
There will be no staff to continue with the study once student finishes PhD.
Date of first participant enrolment
Anticipated
8/12/2018
Actual
Date of last participant enrolment
Anticipated
31/08/2019
Actual
Date of last data collection
Anticipated
31/08/2019
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 11242 0
South Australian Health and Medical Research Institute (SAHMRI) - Adelaide
Recruitment postcode(s) [1] 23115 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 299920 0
Other
Name [1] 299920 0
South Australian Health and Medical Research Institute (SAHMRI)
Country [1] 299920 0
Australia
Primary sponsor type
Other
Name
South Australian Health and Medical Research Institute (SAHMRI)
Address
North Terrace
Adelaide, SA 5000
Country
Australia
Secondary sponsor category [1] 299288 0
None
Name [1] 299288 0
Address [1] 299288 0
Country [1] 299288 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300789 0
Bellberry Limited
Ethics committee address [1] 300789 0
129 Glen Osmond Road
Eastwood SA, 5063
Ethics committee country [1] 300789 0
Australia
Date submitted for ethics approval [1] 300789 0
03/08/2018
Approval date [1] 300789 0
22/10/2018
Ethics approval number [1] 300789 0
Application No: 2018-05-368

Summary
Brief summary
Increasing evidence suggests that sleep apnoea is an important factor driving CVD risk. Beyond worsening blood pressure and diabetes, sleep apnoea has direct adverse effects on blood vessels. In this study, we propose to employ a molecular imaging approach to investigate the impact of OSA on plaque activity. This study is a cross-sectional, observational study with the objective to ascertain the presence and extent of inflammatory activity of atherosclerotic plaque in patients with sleep apnoea. We will enroll 50 adults with obstructive sleep apnoea (OSA), 25 with mild OSA and 25 with moderate to severe OSA commencing continuous positive airways pressure (CPAP) therapy with either established atherosclerotic cardiovascular disease (ASCVD) or risk factors for ASCVD. A combined computed tomography (CT) and positron emission tomography (PET) scan will be performed following intravenous administration of is 18F-fluorodeoxyglucose (18F-FDG) which will enable measurement of inflammatory plaque activity. The findings will provide important information that may lead to the development of an important new marker to monitor reductions in CVD risk in sleep apnoea.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 49642 0
Ms Jordan Andrews
Address 49642 0
South Australia Health and Medical Research Institute
North Terrace
Adelaide, SA 5000
Country 49642 0
Australia
Phone 49642 0
+61 8 8128 4503
Fax 49642 0
Email 49642 0
[email protected]
Contact person for public queries
Name 49643 0
Ms Jordan Andrews
Address 49643 0
South Australia Health and Medical Research Institute
North Terrace
Adelaide, SA 5000
Country 49643 0
Australia
Phone 49643 0
+61 8 8128 4503
Fax 49643 0
Email 49643 0
[email protected]
Contact person for scientific queries
Name 49644 0
Ms Jordan Andrews
Address 49644 0
South Australia Health and Medical Research Institute
North Terrace
Adelaide, SA 5000
Country 49644 0
Australia
Phone 49644 0
+61 8 8128 4503
Fax 49644 0
Email 49644 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
This is a student project at a single centre, not a large clinical trial. The approved ethics application does not include IPD sharing.


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.