Ischemic Stroke Clinical Trial
Official title:
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
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.
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.
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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