sing Molecular Plaque Imaging to Ascertain Cardiovascular Risk in Patients with Sleep Apnoea

Not Applicable

Withdrawn

• Conditions: Atherosclerotic Cardiovascular Disease; Sleep Apnoea; Cardiovascular - Coronary heart disease; Respiratory - Sleep apnoea

• Registration Number: ACTRN12618001327279
• Lead Sponsor: South Australian Health and Medical Research Institute (SAHMRI)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-08-07
• Last Update Posted: 22 July 2019

Recruitment & Eligibility

• Status: Withdrawn
• Sex: All
• Target Recruitment: 50

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)

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

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
ascertain the presence of inflammatory activity of atherosclerotic plaque in atherosclerotic cardiovascular disease patients with OSA. <br><br>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. [baseline]

Secondary Outcome Measures

Name	Time	Method
ascertain the extent of inflammatory activity of atherosclerotic plaque in atherosclerotic cardiovascular disease patients with OSA <br><br>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. [baseline]