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

Purpose

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.

Condition
TIA Ischemic Stroke

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
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

Resource links provided by NLM:

MedlinePlus related topics: Atherosclerosis Transient Ischemic Attack

U.S. FDA Resources

Further study details as provided by Ospedale Civico, Lugano:

Biospecimen Retention: Samples Without DNA

Plasma, serum

Estimated Enrollment:	1000
Study Start Date:	July 2010
Estimated Study Completion Date:	December 2013
Estimated Primary Completion Date:	October 2011 (Final data collection date for primary outcome measure)

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.

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

Ages Eligible for Study:	35 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Patients with TIA or ischemic stroke consecutively admitted in a Stroke Unit within 2 days from onset of symptoms Patients with TIA/ ischemic stroke within the last 60-90 days or previously screened in the short-term observational study

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01097967

Contacts

Contact: Claudio Bassetti, Prof.	+41 91 811 6257	claudio.bassetti@eoc.ch
Contact: Carlo Cereda, Capo Clinica	+41 91 811 6199	carlo.cereda@eoc.ch

Locations

Italy
Dipartimento Neuroscienze, Ospedale Niguarda	Not yet recruiting
Milan, Lombardia, Italy, I-20162
Principal Investigator: Lino Nobili, Professor
Sub-Investigator: Alfonso Ciccone, Dr. med.
Sub-Investigator: Daria Roccatagliata, Dr. med.
Switzerland
Schlafklinik Barmelweid AG	Recruiting
Barmelweid, Aargau, Switzerland, CH-5017
Contact: Ramin Khatami, MD ramin.khatami@barmelweid.ch
Contact: Katharina Grohme, MD Kathraina.Grohme@barmelweid.ch
Sub-Investigator: Ramin Khatami, Dr. med.
Ospedale San Giovanni	Recruiting
Bellinzona, Ticino, Switzerland, CH-6500
Contact: Sandor Gyoerik-Lora, Dr. med. + 41 91 811 89 27 Sandor.Gyoerik-Lora@eoc.ch
Contact: Maria Pfefferle, Dr. med. + 41 91 811 89 27 Maria.Pfefferle@eoc.ch
Principal Investigator: Sandor Györik, Dr. med.
Sub-Investigator: Augusto Gallino, Dr. med.
Sub-Investigator: Pierluigi Pedrazzi, Dr. med.
Neurocenter of Southern Switzerland, Ospedale Civico	Recruiting
Lugano, Ticino, Switzerland, CH-6900
Contact: Carlo Cereda, MD +41 91 811 6691 carlo.cereda@eoc.ch
Principal Investigator: Claudio Bassetti, Professor
Sub-Investigator: Carlo Cereda, Capo Clinica
Sub-Investigator: Marco Pons, Primario
Inselspital, Universitätsklinik für Pneumologie	Recruiting
Bern, Switzerland, CH-3010
Contact: Sebastian Ott, Dr. med. +41 31 632 34 90 sebastian.ott@insel.ch
Contact: Urs Fischer, Dr. med. +41 31 632 03 64 urs.fischer@insel.ch
Principal Investigator: Sebastian Ott, Dr. med.
Sub-Investigator: Matthias Gugger, Dr. med.
Sub-Investigator: Johannes Mathis, Dr. med.
Sub-Investigator: Heinrich Mattle, Dr. med.
Sub-Investigator: Urs Fischer, Dr. med.
Neurology, Stroke Unit, University Hospital	Recruiting
Zurich, Switzerland, CH-8091
Contact: Andreas Luft, Prof. aluft@jhu.edu
Contact: Juliane Schneider, MD juliane.schneider@usz.ch
Principal Investigator: Andreas Luft, Professor
Sub-Investigator: Juliane Schneider, Dr. med.
Sub-Investigator: Esther Werth, Dr. med.
Sub-Investigator: Christian Baumann, Dr. med.

Sponsors and Collaborators

Ospedale Civico, Lugano

Swiss National Science Foundation

Schweizerische Herzstiftung

ResMed

Philips Respironics

Investigators

Principal Investigator:	Claudio Bassetti, Professor	Neurocentre of Southern Switzerland, Ospedale Civico
Study Chair:	Carlo Cereda, Capo CLinica	Neurocentre of Southern Switzerland, Ospedale Civico
Study Chair:	Andreas Luft, Professor	Neurology, Stroke Unit, University Hospital, Zürich
Study Chair:	Sebastian Ott, Dr. Med.	Pneumology, University Hospital, Bern
Study Chair:	Ramin Khatami, Dr. med.	Schlafklinik Barmelweid, Aarau
Study Chair:	Lino Nobili, Dr. med.	Neurology, Stroke Unit, Ospedale Niguarda, Milan, Italy

More Information

Additional Information:

Click here to see more information about our hospital This link exits the ClinicalTrials.gov site

Swiss Nationa Foundation provides finacial support for the study This link exits the ClinicalTrials.gov site

provides financial support for the study This link exits the ClinicalTrials.gov site

Publications:

Bassetti C, Aldrich M, Chervin R, Quint D. Sleep apnea in the acute phase of TIA and Stroke. Neurology 1996;47:1167-73.

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

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.

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.

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. Epub 2009 Apr 30.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Cereda CW, Petrini L, Azzola A, Ciccone A, Fischer U, Gallino A, Györik 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.

Responsible Party:	Claudio Bassetti, Professor Dr., Neurocentre of Southern Switzerland, Ospedale Civico
ClinicalTrials.gov Identifier:	NCT01097967 History of Changes
Other Study ID Numbers:	EOC.NC.10.01, 320030-125069/1
Study First Received:	April 1, 2010
Last Updated:	May 31, 2011
Health Authority:	Switzerland: Ethikkomission

Keywords provided by Ospedale Civico, Lugano:

Sleep disordered breathing
Continuous Positive Airway Pressure
Sleep apnoea
Markers of atherosclerosis

Additional relevant MeSH terms:

Respiratory Aspiration
Ischemic Attack, Transient
Ischemia
Sleep Apnea Syndromes
Stroke
Cerebral Infarction
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Brain Ischemia
Cerebrovascular Disorders

Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Apnea
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Brain Infarction

ClinicalTrials.gov processed this record on May 23, 2013

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