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

Prof. Claudio Bassetti

Status and phase: Unknown; Phase 4

Conditions: TIA; Ischemic Stroke

Treatments: Other: CPAP

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01097967

320030-125069/1 (Other Grant/Funding Number)

EOC.NC.10.01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 246 patients

Sex: All

Ages: 35 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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246 participants in 3 patient groups

CPAP in sleepy patients with SDB

Active Comparator group

Description:

SDB defined as AHI \>=20 Sleepy defined as Epworth Sleepiness Score \>=10

Treatment:

Other: CPAP

no CPAP in non sleepy patients with SDB

No Intervention group

Description:

SDB defined as AHI \>=20 Sleepy defined as Epworth Sleepiness Score \>=10

CPAP in non sleepy patients with SDB

Active Comparator group

Description:

SDB defined as AHI \>=20 Sleepy defined as Epworth Sleepiness Score \>=10

Treatment:

Other: CPAP