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

Active, not recruiting

Phase 4 Results N/A

Trial Description

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.

Detailed Description

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.

Conditions

Interventions

  • CPAP Device
    ARM 1: Kind: Experimental
    Label: CPAP in sleepy patients with SDB
    Description: SDB defined as AHI >=20 Sleepy defined as Epworth Sleepiness Score >=10
    ARM 2: Kind: Experimental
    Label: CPAP in non sleepy patients with SDB
    Description: SDB defined as AHI >=20 Sleepy defined as Epworth Sleepiness Score >=10

Trial Design

  • Allocation: Randomized
  • Masking: Open Label
  • Purpose: Prevention
  • Intervention: Parallel Assignment
  • Observation: Cohort
  • Perspective: Prospective

Outcomes

Type Measure Time Frame Safety Issue
Primary Occurence of new vascular events or death in stroke survivors (myocardial infarction, stroke, death) assessed by telephone or reported 24 monts after stroke No
Secondary CPAP-Compliance measured by hours of usage up to 24 months after stroke No
Secondary 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 No
Secondary 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 No

Sponsors