CTRI/2009/091/000410Other3 期
An 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 and moderate-severe obstructive sleep apnea
Adelaide Institute for Sleep Health0 个研究点目标入组 5,000 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- Other
- 发起方
- 入组人数
- 5,000
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
入选标准
- •Inclusion Criteria
- •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
- •Previous MI â?? with delay of at least 90 days prior to Apnealink assessment; or
- •History of angina with documented coronary artery disease at angiography, defined as either 70 percent or more diameter stenosis of at least one major epicardial artery segment, or More than or equal to 50percent diameter stenosis of the left main coronary artery, or >50percent stenosis in at least two major epicardial arteries. (Clinical event more than or equal 30 days and confirmatory test 7 days or more prior to ApneaLink assessment; or
- •History of angina with documented coronary artery disease at an exercise stress test (ST depression more than or equal 2 mm) and or a positive nuclear perfusion scintigram. Clinical event more than or equal to 30 days and confirmatory test more than or equal 7 days prior to ApneaLink assessment).; or
- •Multi-vessel coronary revascularisation (coronary artery bypass surgery (CABG) and or percutaneous angioplasty (PTCA)) with delay of at least 90 days prior to ApneaLink assessment.
- •b. Cerebrovascular disease
- •Previous stroke (includes definite or presumed cerebral ischaemia/infarction and intracerebral, but not subarachnoid haemorrhage) >=90 days prior to ApneaLink assessment; or minor disabling stroke with minimal residual neurological disability (modified Rankin Score of 0 or 1, able to carry out all usual duties and activitiesâ?? within 7 days of stroke onset) more than or equal 7 days prior to ApneaLink assessment.
- •Previous transient ischaemic event TIA of the brain or retina (standard definition symptoms less than 24 hours), but not of presumed vertebrobasilar system ischemia. The TIA diagnosis must be confirmed by a suitably qualified clinician more than or equal 7 days to less than 1year prior to ApneaLink assessment.
- •3. Patients have moderate-severe OSA (equivalent to apnea plus hypopneas index more than 30 per hour of sleep) as determined by a > 4percent oxygen dip rate > 12/ h on overnight testing using the ApneaLink 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
- •Exclusion Criteria
- •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,
- •co-morbid disease with severe disability or likelihood of death within the next 2 years
- •significant memory, perceptual, or behavioural disorder
- •neurological deficit (eg. limb paresis) preventing self administration of the CPAP mask
- •residence sufficiently remote from the clinic to preclude follow-up clinic visits
- •contraindications to CPAP use such as current pneumothorax
- •2 Any planned coronary or carotid revascularisation procedure in the next 6 months
- •3 Severe respiratory disease defined as
- •severe chronic obstructive pulmonary disease or
- •resting, awake SaO2 less than 90percent by ApneaLink device
- •4 New York Heart Association categories III-IV of heart failure
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 renders the patient
- •unsuitable for the study Eg. Co-morbid disease with severe disability; significant memory,
- •perceptual, or behavioural disorder; lives remote form the study centre
- •2. Any planned coronary or carotid revascularisation procedure in the next 6 months
- •3. Severe respiratory disease defined as
- •.severe chronic obstructive pulmonary disease (FEV1/FVC <70% and FEV1 <50%
- •predicted), or
- •.resting, awake SaO2 < 90% by ApneaLinkTM device
- •4. New York Heart Association (NYHA) categories III-IV of heart failure
- •5. Stroke due to subarachnoid haemorrhage
- •6. Other household member enrolled in SAVE trial or using CPAP
- •7. Prior use of CPAP treatment for OSA
- •8. Increased risk of a sleep-related accident and/or excessive daytime sleepiness, defined by any
- •one of the following:
- •.driver occupation (e.g. truck, taxi)
- •.'fall-asleep' accident or 'near miss' accident in previous 12 months
- •.high (>15) score on the Epworth Sleepiness Scale
- •9. Severe nocturnal desaturation documented on the ApneaLinkTM device, as
- •. >10% overnight recording time with arterial oxygen saturation of <=80%
- •10. Cheyne-Stokes Respiration (CSResp)
- •. CSResp identified on ApneaLinkTM nasal pressure recording by typical crescendodecrescendo
- •pattern of respiration with associated apneas and/or hypopneas in the absence of inspiratory flow limitation.
- •.patients excluded if >50% of nasal pressure ? defined apneas and hypopneas judged to be due to CSResp.
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