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

Ischemic Stroke Clinical Trial

— SAS-CARE  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01097967
• Other study ID #: EOC.NC.10.01
• Secondary ID: 320030-125069/1
• Status: Active, not recruiting
• Phase: Phase 4
• First received: April 1, 2010
• Last updated: October 23, 2015
• Start date: July 2010
• Est. completion date: April 2016

Study information

• Verified date: October 2015
• Source: Ospedale Civico, Lugano
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkomission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 246
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Ischemia
• Ischemic Attack, Transient
• Ischemic Stroke
• Stroke
• TIA

Intervention

Other:
• CPAP

Locations

Country	Name	City	State
Germany	University Hospital Münster	Münster
Italy	Dipartimento Neuroscienze, Ospedale Niguarda	Milan	Lombardia
Switzerland	Ospedale San Giovanni	Bellinzona	Ticino
Switzerland	Inselspital, Universitätsklinik für Pneumologie	Bern
Switzerland	Neurocenter of Southern Switzerland, Ospedale Civico	Lugano	Ticino

Sponsors (5)

Lead Sponsor	Collaborator
Prof. Claudio Bassetti	Philips Respironics, ResMed, Schweizerische Herzstiftung, Swiss National Science Foundation

Countries where clinical trial is conducted

Germany,  Italy,  Switzerland, 

References & Publications (5)

Bassetti C, Aldrich MS, Chervin RD, Quint D. Sleep apnea in patients with transient ischemic attack and stroke: a prospective study of 59 patients. Neurology. 1996 Nov;47(5):1167-73. — View Citation

Bassetti C, Aldrich MS. Sleep apnea in acute cerebrovascular diseases: final report on 128 patients. Sleep. 1999 Mar 15;22(2):217-23. — View Citation

Bassetti CL, Milanova M, Gugger M. Sleep-disordered breathing and acute ischemic stroke: diagnosis, risk factors, treatment, evolution, and long-term clinical outcome. Stroke. 2006 Apr;37(4):967-72. Epub 2006 Mar 16. — View Citation

Marin JM, Carrizo SJ, Vicente E, Agusti AG. Long-term cardiovascular outcomes in men with obstructive sleep apnoea-hypopnoea with or without treatment with continuous positive airway pressure: an observational study. Lancet. 2005 Mar 19-25;365(9464):1046-53. — View Citation

Martínez-García MA, Soler-Cataluña JJ, Ejarque-Martínez L, Soriano Y, Román-Sánchez P, Illa FB, Canal JM, Durán-Cantolla J. Continuous positive airway pressure treatment reduces mortality in patients with ischemic stroke and obstructive sleep apnea: a 5-year follow-up study. Am J Respir Crit Care Med. 2009 Jul 1;180(1):36-41. doi: 10.1164/rccm.200808-1341OC. Epub 2009 Apr 30. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	24 monts after stroke	No
Secondary	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.	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	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).	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	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).	up to 12 months after stroke	No

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