ACTRN12608000409370已完成3 期
SAVE (Sleep Apnea cardioVascular Endpoints) studyAn international, multi-centre, open, parallel group, prospective, randomised, controlled trial to determine the effectiveness of treatment with continuous positive airways pressure (CPAP) in addition to standard care in reducing cardiovascular (CV) morbidity and mortality in patients with co-existing CV disease and moderate-severe obstructive sleep apnea (OSA).
Respironics Sleep and Respiratory Research Foundation0 个研究点目标入组 2,500 人开始时间: 2008年8月20日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 2,500
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Prevention
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 45 Years 至 75 Years（—）
- 性别
- All
入选标准
- •1. Males and females, any race, and aged between 45 and 75 years
- •2. Evidence of established coronary or cerebrovascular disease as evident by;
- •(a) Coronary artery disease.
- •i. Previous MI (greater than or equal to 90 days prior to ApneaLinkTM assessment); or
- •ii. Stable angina or unstable angina (Clinical event greater than or equal to 30 days and confirmatory test equal to or greater than 7 days prior to ApneaLinkTM assessment) defined as either greater than or equal to 70% diameter stenosis of at least one major epicardial artery segment, or greater than or equal to 50% diameter stenosis of the left main coronary artery, or greater than 50% stenosis in at least two major epicardial arteries, or positive stress test (ST depression greater than or equal to 2 mm or a positive nuclear perfusion scintigram); or
- •iii. Multi-vessel percutaneous angioplasty (PTCA) and/or stent greater than or equal to 90 days prior to ApneaLinkTM assessment; or
- •iv. Multi-vessel coronary artery bypass surgery (CABG) greater than 1 year prior to ApneaLinkTM assessment
- •(b) Cerebrovascular disease
- •i. Previous stroke (includes definite or presumed cerebral ischaemia/infarction and intracerebral but not subarachnoid haemorrhage) greater than or equal to 90 days prior to ApneaLinkTM assessment; or or minor disabling stroke with minimal residual neurological disability (modified Rankin Score of ‘0 equal to no symptoms’ or ‘1 equal to No significant disability despite symptoms, able to carry out all usual duties and activities’ within 7 days of stroke onset) greater than or equal to 7 days prior to ApneaLinkTM assessment; or
- •ii. Previous transient ischaemic event (TIA) of the brain or retina (symptoms less than 24 hours) but not of presumed vertebrobasilar system ischemia. The TIA diagnosis must be confirmed by a suitably qualified clinician (greater than or equal to 7 days but less than 1 year prior to ApneaLinkTM assessment)
- •3. Patients have moderate-severe OSA (equivalent to apnea plus hypopneas index [AHI] greater than 30 per hour of sleep) as determined by a greater than 4% oxygen dip rate greater than 12/ h on overnight testing using the ApneaLinkTM device and confirmed by the SAVE corelab in Adelaide upon receipt of the ApneaLink data; and
- •4. Patients are able and willing to give appropriate informed consent
排除标准
- •Patients will be excluded from entry if ANY of the criteria listed below are met:
- •1. Any condition that in the opinion of the responsible physician or investigator makes the potential participant unsuitable for the study. For example,
- •i. co-morbid disease with severe disability or likelihood of death
- •ii. significant memory, perceptual, or behavioural disorder
- •iii. neurological deficit (eg. limb paresis) preventing self administration of the CPAP mask
- •iv. contraindication to CPAP use e.g. pneumothoraxv residence sufficiently remote from the clinic to preclude follow-up clinic visits
- •2. Any planned coronary or carotid revascularisation procedure in the next 6 months
- •3. Severe respiratory disease defined as
- •i. severe chronic obstructive pulmonary disease (FEV1/FVC greater than 70% and FEV1 less than 50% predicted), or
- •ii. resting, awake SaO2 less than 90% by ApneaLinkTM device
- •4. New York Heart Association (NYHA) categories III-IV of heart failure
- •5. Other household member enrolled in SAVE trial or using CPAP
- •6. Prior use of CPAP treatment for OSA
- •7. Increased risk of a sleep-related accident and/or excessive daytime sleepiness, defined by any one of the following:
- •i. driver occupation (eg truck, taxi)
- •ii. ‘fall-asleep’ accident or ‘near miss’ accident in previous 12 months
- •iii. high (greater than 15) score on the Epworth Sleepiness Scale
- •8. Severe nocturnal desaturation documented on the ApneaLinkTM device as i. greater than 10% overnight recording time with arterial oxygen saturation of less than 80%
- •9. Cheyne-Stokes Respiration (CSResp)
- •i. CSResp identified on ApneaLinkTM nasal pressure recording by typical crescendo-decrescendo pattern of respiration with associated apneas and/or hypopneas in the absence of inspiratory flow limitation.
- •ii. patients excluded if greater than 50% of nasal pressure – defined apneas and hypopneas judged to be due to CSResp.
研究者
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