Sleep Disordered Breathing in Transient Ischemic Attack (TIA)/Ischemic Stroke and Continuous Positive Airway Pressure (CPAP) Treatment Efficacy (SAS-CARE)
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| ClinicalTrials.gov Identifier: NCT01097967 |
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Recruitment Status : Unknown
Verified October 2015 by Prof. Claudio Bassetti, Ospedale Civico, Lugano.
Recruitment status was: Active, not recruiting
First Posted : April 2, 2010
Last Update Posted : October 26, 2015
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| TIA Ischemic Stroke | Other: CPAP | Phase 4 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 246 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Prevention |
| 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 Start Date : | July 2010 |
| Estimated Primary Completion Date : | April 2016 |
| Estimated Study Completion Date : | April 2016 |
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: CPAP in sleepy patients with SDB
SDB defined as AHI >=20 Sleepy defined as Epworth Sleepiness Score >=10
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Other: CPAP |
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No Intervention: no CPAP in non sleepy patients with SDB
SDB defined as AHI >=20 Sleepy defined as Epworth Sleepiness Score >=10
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Active Comparator: CPAP in non sleepy patients with SDB
SDB defined as AHI >=20 Sleepy defined as Epworth Sleepiness Score >=10
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Other: CPAP |
- 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 ]New vascular events will be assessed by regular telephone interviews at 6,12 and 24 months after stroke
- CPAP-Compliance measured by hours of usage [ Time Frame: up to 24 months after stroke ]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.
- 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 ]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).
- 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 ]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).
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| Ages Eligible for Study: | 35 Years to 75 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01097967
| Germany | |
| University Hospital Münster | |
| Münster, Germany | |
| Italy | |
| Dipartimento Neuroscienze, Ospedale Niguarda | |
| Milan, Lombardia, Italy, I-20162 | |
| Switzerland | |
| Ospedale San Giovanni | |
| Bellinzona, Ticino, Switzerland, CH-6500 | |
| Neurocenter of Southern Switzerland, Ospedale Civico | |
| Lugano, Ticino, Switzerland, CH-6900 | |
| Inselspital, Universitätsklinik für Pneumologie | |
| Bern, Switzerland, CH-3010 | |
| Principal Investigator: | Claudio Bassetti, Professor | Universitätsspital Bern (Inselspital) und Universität Bern | |
| Study Chair: | Carlo Cereda, Capo CLinica | Neurocentre of Southern Switzerland, Ospedale Civico | |
| Study Chair: | Sebastian Ott, MD | Pneumology, University Hospital, Bern | |
| Study Chair: | Lino Nobili, Prof. MD | Neurology, Stroke Unit, Ospedale Niguarda, Milan, Italy | |
| Study Chair: | Mauro Manconi, MD | Neurocentre of Southern Switzerland, Ospedale Civico | |
| Study Chair: | Peter Young, Prof. MD | Universitätsklinik Münster, Zentrum für Schlafmedizin |
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Prof. Claudio Bassetti, Dr. med. Claudio Bassetti, Ospedale Civico, Lugano |
| ClinicalTrials.gov Identifier: | NCT01097967 |
| Other Study ID Numbers: |
EOC.NC.10.01 320030-125069/1 ( Other Grant/Funding Number: Swiss National Science Foundation (SNSF) ) |
| First Posted: | April 2, 2010 Key Record Dates |
| Last Update Posted: | October 26, 2015 |
| Last Verified: | October 2015 |
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Sleep disordered breathing Continuous Positive Airway Pressure Sleep apnoea Markers of atherosclerosis |
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Sleep Apnea Syndromes Stroke Ischemic Stroke Cerebral Infarction Ischemia Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Vascular Diseases Cardiovascular Diseases |
Pathologic Processes Brain Infarction Brain Ischemia Infarction Necrosis Respiration Disorders Respiratory Tract Diseases Apnea Sleep Disorders, Intrinsic Dyssomnias Sleep Wake Disorders |