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Study to evaLuate the Effect of trEating obstructive sleeP apnoea on coronary atherosclerosis with Computed Tomography (SLEEP-CT)

Study to evaLuate the Effect of trEating obstructive sleeP apnoea on coronary atherosclerosis with Computed Tomography

Status
Withdrawn
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12618001328268
Acronym
SLEEP-CT
Enrollment
75
Registered
2018-08-07
Start date
2018-09-03
Completion date
2019-08-31
Last updated
2019-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Several factors link OSA and atherosclerosis, including metabolic abnormalities, activation of inflammatory and oxidative pathways, autonomic dysfunction and mechanical factors linked to snoring. However, the relationship between OSA and its treatment with the burden and progression of atherosclerotic plaque has not been systematically investigated. Advances in computed tomography (CT) imaging permit noninvasive high-resolution plaque imaging, enabling characterisation of the factors driving disease progression. This study is an observational study of 75 adults to determine the relationship between OSA and its treatment with plaque burden, composition and progression. Imaging of the coronary arteries will be performed on a CT scanner at a baseline and 12 month follow-up visit. The baseline phase permits evaluation of the relationship between OSA and its severity with the extent, distribution and composition of plaque. The serial phase permits a real-world assessment of the impact of changes in OSA severity on plaque progression.

Interventions

Patients with moderate to severe (bases on a clinically indicated PSG) OSA will participate in this study as defined as either AHI >= 15 and both minimal symptoms (ESS <10 and no self-reported falling asleep accident/near miss accident in the last 6 months) and lack of resistant hypertension OR AHI >=15 and either high symptom load (ESS>10 or self-reported falling asleep accident/near miss accident in the last 6 months) or resistant hypertension (elevated blood pressure despite >3 agents) re

Patients with moderate to severe (bases on a clinically indicated PSG) OSA will participate in this study as defined as either AHI >= 15 and both minimal symptoms (ESS <10 and no self-reported falling asleep accident/near miss accident in the last 6 months) and lack of resistant hypertension OR AHI >=15 and either high symptom load (ESS>10 or self-reported falling asleep accident/near miss accident in the last 6 months) or resistant hypertension (elevated blood pressure despite >3 agents) requiring CPAP Imaging of the coronary arteries will be performed following administration of an intravenous bolus of contrast on a computed tomography (CT) scanner capable of computed tomography coronary angiogram (CTCA) imaging doe by a trained radiographer at the Clinical Research Imaging Centre (CRIC) at baseline (day 1) (within 4 weeks of PSG) and 12 months in patients with coronary artery disease risk factors and symptoms suggestive of sleep apnoea. The CT scan will take about 30 minutes.

Sponsors

South Australian Health and Medical Research Institute (SAHMRI)
Lead SponsorOther

Eligibility

Sex/Gender
All
Age
40 Years to No maximum
Healthy volunteers
No

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) 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 be followed for serial CT evaluation c. Chronic kidney disease (use of dialysis or eGRF <30 mL/min given the need to administer intravenous contrast) d. Severe respiratory disease (severe chronic obstructive pulmonary disease, resting daytime SaO2 <90%) e. New York Heart Association heart failure class III-IV f. Prior coronary artery bypass grafting g. Prior use of CPAP for OSA in the last 12 months h. Central sleep apnea >5 events/hour i. Significant comorbidity with a high likelihood of death in the next 12 months j. Any condition that in the opinion of the responsible physician or investigator renders the participant unsuitable for the study E.g. severe disability; significant memory, perceptual, or behavioural disorder

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026