Overview

This trial is active, not recruiting.

Conditions tia, ischemic stroke
Treatment cpap
Phase phase 4
Sponsor Prof. Claudio Bassetti
Collaborator Swiss National Science Foundation
Start date July 2010
End date April 2016
Trial size 246 participants
Trial identifier NCT01097967, 320030-125069/1, EOC.NC.10.01

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose prevention
Arm
(Active Comparator)
SDB defined as AHI >=20 Sleepy defined as Epworth Sleepiness Score >=10
cpap
(No Intervention)
SDB defined as AHI >=20 Sleepy defined as Epworth Sleepiness Score >=10
(Active Comparator)
SDB defined as AHI >=20 Sleepy defined as Epworth Sleepiness Score >=10
cpap

Primary Outcomes

Measure
Occurence of new vascular events or death in stroke survivors (myocardial infarction, stroke, death) assessed by telephone or reported
time frame: 24 monts after stroke

Secondary Outcomes

Measure
CPAP-Compliance measured by hours of usage
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
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
time frame: up to 12 months after stroke

Eligibility Criteria

Male or female participants from 35 years up to 75 years old.

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

Additional Information

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
Principal investigator Claudio Bassetti, Professor
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2015.
Information provided to ClinicalTrials.gov by Ospedale Civico, Lugano.