Sleep Disordered Breathing in Transient Ischemic Attack (TIA)/Ischemic Stroke and Continuous Positive Airway Pressure (CPAP) Treatment Efficacy

Prof. Claudio Bassetti246 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Eligibility

Sex: ALLMin age: 35 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * ≥ 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 Exclusion Criteria: * 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

Locations (5)

University Hospital Münster

Münster, Germany

Dipartimento Neuroscienze, Ospedale Niguarda

Milan, Lombardy, Italy

Inselspital, Universitätsklinik für Pneumologie

Bern, Canton of Bern, Switzerland

Ospedale San Giovanni

Bellinzona, Canton Ticino, Switzerland

Neurocenter of Southern Switzerland, Ospedale Civico

Lugano, Canton Ticino, Switzerland

Outcomes

Primary Outcomes

Occurence of new vascular events or death in stroke survivors (myocardial infarction, stroke, death) assessed by telephone or reported

New vascular events will be assessed by regular telephone interviews at 6,12 and 24 months after stroke

Time frame: 24 monts after stroke

Secondary Outcomes

CPAP-Compliance measured by hours of usage

Compliance is monitored for the use of the CPAP by the pulmonary specialist at the patients' routine visits 2-3, 4-6 weeks, 3-6 months, 12 and 24 months after randomisation. The hours ofuse are registered by a chip inserted in the device. Good compliance is, if the device was used \> 10 hours per day. Satisfactory compliance is defined for a use of the CPAP for at least 4 hours per night during at least 70% of the nights. Insufficient compliance is defined as \< 4 hours per night or less than 70% of nights.

Time frame: 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

Mean systolic and diastolic BP values, minimal and maximum values will be calculated for each patient for each period of time \[after stroke: whole measuring period, (36 h) first night, second day, and second night after stroke; 3 months after stroke: whole period (24 h), day, night\]. In addition same measurements will be made 12 months after stroke The occurrence of dippers will be registered at baseline (after stroke) and at 3 months. A dipper is defined, if the mean pressure at night is diminished more than 10% (compared to day data). An inverse-dipper is defined if more than 10% augmentation of night pressure will be registered. A deep-deeper is defined the mean pressure at night is diminished more than 20% (compared to day data).

Time frame: up to 12 months after stroke

Blood pressure dipping measured by ambulatory 24h-BP-devices in the acute stroke phase, after 3 months and after 12 months

The occurrence of dippers will be registered at baseline (after stroke) and at 3 months and 12 months after stroke. A dipper is defined, if the mean pressure at night is diminished more than 10% (compared to day data). An inverse-dipper is defined if more than 10% augmentation of night pressure will be registered. A deep-deeper is defined the mean pressure at night is diminished more than 20% (compared to day data).