Clinical trial NCT01097967: Sleep Disordered Breathing in Transient Ischemic Attack (TIA)/Ischemic Stroke and Continuous Positive Airway Pressure (CPAP) Treatment Efficacy
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: TIA
Ischemic Stroke
Keywords: Sleep disordered breathing
Continuous Positive Airway Pressure
Sleep apnoea
Markers of atherosclerosis
Lead sponsor: Ospedale Civico, Lugano
Sponsor class: OTHER_GOV
Collaborators: name: Swiss National Science Foundation
name: Schweizerische Herzstiftung
name: ResMed
name: Philips Respironics
First posted: 2010-04-02
Enrollment: 246
Sex: ALL
Minimum age (years): 35
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Occurence of new vascular events or death in stroke survivors (myocardial infarction, stroke, death) assessed by telephone or reported
timeFrame: 24 monts after stroke
Secondary outcomes:
measure: CPAP-Compliance measured by hours of usage
timeFrame: up to 24 months after stroke
measure: 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
timeFrame: up to 12 months after stroke
measure: Blood pressure dipping measured by ambulatory 24h-BP-devices in the acute stroke phase, after 3 months and after 12 months
timeFrame: up to 12 months after stroke
Other outcomes:
Locations:
city: Münster
country: Germany
facility: University Hospital Münster
city: Milan
country: Italy
facility: Dipartimento Neuroscienze, Ospedale Niguarda
state: Lombardia
city: Bellinzona
country: Switzerland
facility: Ospedale San Giovanni
state: Ticino
city: Lugano
country: Switzerland
facility: Neurocenter of Southern Switzerland, Ospedale Civico
state: Ticino
city: Bern
country: Switzerland
facility: Inselspital, Universitätsklinik für Pneumologie
Study officials:
affiliation: Universitätsspital Bern (Inselspital) und Universität Bern
name: Claudio Bassetti, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Neurocentre of Southern Switzerland, Ospedale Civico
name: Carlo Cereda, Capo CLinica
role: STUDY_CHAIR
affiliation: Pneumology, University Hospital, Bern
name: Sebastian Ott, MD
role: STUDY_CHAIR
affiliation: Neurology, Stroke Unit, Ospedale Niguarda, Milan, Italy
name: Lino Nobili, Prof. MD
role: STUDY_CHAIR
affiliation: Neurocentre of Southern Switzerland, Ospedale Civico
name: Mauro Manconi, MD
role: STUDY_CHAIR
affiliation: Universitätsklinik Münster, Zentrum für Schlafmedizin
name: Peter Young, Prof. MD
role: STUDY_CHAIR
References:
citation: 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. doi: 10.1212/wnl.47.5.1167.
citation: Bassetti C, Aldrich MS. Sleep apnea in acute cerebrovascular diseases: final report on 128 patients. Sleep. 1999 Mar 15;22(2):217-23. doi: 10.1093/sleep/22.2.217.
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. doi: 10.1016/S0140-6736(05)71141-7.
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. doi: 10.1161/01.STR.0000208215.49243.c3. Epub 2006 Mar 16.
citation: Martinez-Garcia MA, Soler-Cataluna JJ, Ejarque-Martinez L, Soriano Y, Roman-Sanchez P, Illa FB, Canal JM, Duran-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.
citation: Pace M, Camilo MR, Seiler A, Duss SB, Mathis J, Manconi M, Bassetti CL. Rapid eye movements sleep as a predictor of functional outcome after stroke: a translational study. Sleep. 2018 Oct 1;41(10). doi: 10.1093/sleep/zsy138.
citation: Manconi M, Zavalko I, Cereda C, Pisarenco I, Ott S, Fulda S, Bassetti CL. Longitudinal polysomnographic assessment from acute to subacute phase in infratentorial versus supratentorial stroke. Cerebrovasc Dis. 2014;37(2):85-93. doi: 10.1159/000356323. Epub 2014 Jan 16.
citation: Cereda CW, Petrini L, Azzola A, Ciccone A, Fischer U, Gallino A, Gyorik S, Gugger M, Mattis J, Lavie L, Limoni C, Nobili L, Manconi M, Ott S, Pons M, Bassetti CL. Sleep-disordered breathing in acute ischemic stroke and transient ischemic attack: effects on short- and long-term outcome and efficacy of treatment with continuous positive airways pressure--rationale and design of the SAS CARE study. Int J Stroke. 2012 Oct;7(7):597-603. doi: 10.1111/j.1747-4949.2012.00836.x. Epub 2012 Jul 19.