Sleep Disordered Breathing in TIA/Ischemic Stroke: Effects on Short- and Long-term Outcome and CPAP Treatment Efficacy: an Open, Observational, Clinical, Multicentre Trial With a Randomized Arm
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 246
- 试验地点
- 9
- 主要终点
- Occurence of new vascular events or death in stroke survivors (myocardial infarction, stroke, death) assessed by telephone or reported
研究概览
简要总结
The study aims to observe the short term effect (3-month) of sleep disordered breathing (SDB) on cardiovascular parameters, heart rate variability, endothelial function and surrogate markers of atherosclerosis after acute cerebrovascular events (ACE). The long-term effect (6-24-month) of Continuous Positive Airway Pressure (CPAP) on clinical vascular outcome, cardiovascular parameters, evolution of surrogate of atherosclerosis heart rate variability and endothelial function after ACE is observed over 24 months. A preventive effect of CPAP therapy on cerebro-vascular events in patients with moderate-severe obstructive SDB without sleepiness after ictus or transient ischaemic attack will be evaluated.
详细描述
Sleep disordered breathing is an independent risk factor for cardiovascular morbidity and mortality and is frequent in patients with acute cerebrovascular events. In this study the investigators observe the association between sleep disordered breathing, hypertension, stroke and the evolution of blood markers for atherosclerosis as well as the efficacy of Continuous Positive Airway Pressure treatment in patients with acute or subacute cerebrovascular events.
Sleep disordered breathing is an independent risk factor for cardiovascular morbidity and mortality and is frequent in patients with acute cerebrovascular events. In this study the investigators observe the association between sleep disordered breathing, hypertension, stroke and the evolution of blood markers for atherosclerosis as well as the efficacy of Continuous Positive Airway Pressure treatment in patients with acute or subacute cerebrovascular events.
The SAS CARE 1 study is planned to verify whether or not sleep disordered breathing has a detrimental 3 months effect on cardiovascular functions and markers after acute cerebrovascular events. The SAS CARE 2 study is designed to address whether or not the treatment of sleep disordered breathing with CPAP reduces the combined rate of mortality, stroke, cardiovascular events (myocardial infarction/revascularisation/instable angina/ hospitalisation for heart insufficiency) over a 24 months period in patients after acute cerebrovascular events.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥ 35 years old and < 75 years old
- •with clinical diagnosis of TIA or ischemic stroke
- •admitted in a Stroke Unit within 2 days from onset of symptoms
- •or with TIA or ischemic stroke within the last 60-90 days
- •signed Informed Consent
排除标准
- •with unstable clinical situation (cardio-respiratory or life-threatening medical conditions)
- •currently on CPAP or on CPAP during the last 3 months before stroke
- •with non-ischemic events (intracerebral/subarachnoid haemorrhage)
- •Patients with coma/stupor
- •with borderline obstructive SDB (AHI 10-19)
- •with any condition that interferes with the acceptance of CPAP treatment
结局指标
主要结局
Occurence of new vascular events or death in stroke survivors (myocardial infarction, stroke, death) assessed by telephone or reported
时间窗: 24 monts after stroke
New vascular events will be assessed by regular telephone interviews at 6,12 and 24 months after stroke
次要结局
- Blood pressure dipping measured by ambulatory 24h-BP-devices in the acute stroke phase, after 3 months and after 12 months(up to 12 months after stroke)
- CPAP-Compliance measured by hours of usage(up to 24 months after stroke)
- Blood pressure profile (systolic mean, diastolic mean, max, min: general, day, night) measured in mmHg for every patient by ambulatory 24h-BP-devices in the acute stroke phase, after 3 months and after 12 months(up to 12 months after stroke)
研究者
Prof. Claudio Bassetti
Dr. med. Claudio Bassetti
Ospedale Civico, Lugano