ACTRN12618001327279撤回未知
sing Molecular Plaque Imaging to Ascertain Cardiovascular Risk in Patients with Sleep Apnoea
South Australian Health and Medical Research Institute (SAHMRI)0 个研究点目标入组 50 人开始时间: 2018年8月7日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 撤回
- 发起方
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 40 Years 至 o limit（—）
- 性别
- All
入选标准
- •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
- •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)
排除标准
- •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
研究者
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