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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Ospedale Civico, Lugano
Sponsor:
Collaborators:
Swiss National Science Foundation
Schweizerische Herzstiftung
ResMed
Philips Respironics
Information provided by:
Ospedale Civico, Lugano
ClinicalTrials.gov Identifier:
NCT01097967
First received: April 1, 2010
Last updated: May 19, 2014
Last verified: April 2014
  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:


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 2015
Estimated Primary Completion Date: December 2015 (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.

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 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:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 19, 2014
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:
Cerebral Infarction
Ischemia
Ischemic Attack, Transient
Respiratory Aspiration
Stroke
Brain Diseases
Brain Infarction
Brain Ischemia
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Nervous System Diseases
Pathologic Processes
Respiration Disorders
Respiratory Tract Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 20, 2014