Sleep Disordered Breathing in Transient Ischemic Attack (TIA)/Ischemic Stroke and Continuous Positive Airway Pressure (CPAP) Treatment Efficacy (SAS-CARE)
2015년 10월 23일 업데이트: Prof. Claudio Bassetti
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
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.
연구 개요
상세 설명
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.
연구 유형
중재적
등록 (실제)
246
단계
- 4단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Münster, 독일
- University Hospital Münster
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Bern, 스위스, CH-3010
- Inselspital, Universitätsklinik für Pneumologie
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Ticino
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Bellinzona, Ticino, 스위스, CH-6500
- Ospedale San Giovanni
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Lugano, Ticino, 스위스, CH-6900
- Neurocenter of Southern Switzerland, Ospedale Civico
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Lombardia
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Milan, Lombardia, 이탈리아, I-20162
- Dipartimento Neuroscienze, Ospedale Niguarda
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
35년 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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활성 비교기: CPAP in sleepy patients with SDB
SDB defined as AHI >=20 Sleepy defined as Epworth Sleepiness Score >=10
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간섭 없음: no CPAP in non sleepy patients with SDB
SDB defined as AHI >=20 Sleepy defined as Epworth Sleepiness Score >=10
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활성 비교기: CPAP in non sleepy patients with SDB
SDB defined as AHI >=20 Sleepy defined as Epworth Sleepiness Score >=10
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Occurence of new vascular events or death in stroke survivors (myocardial infarction, stroke, death) assessed by telephone or reported
기간: 24 monts after stroke
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New vascular events will be assessed by regular telephone interviews at 6,12 and 24 months after stroke
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24 monts after stroke
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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CPAP-Compliance measured by hours of usage
기간: up to 24 months after stroke
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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.
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up to 24 months after stroke
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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
기간: up to 12 months after stroke
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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).
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up to 12 months after stroke
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Blood pressure dipping measured by ambulatory 24h-BP-devices in the acute stroke phase, after 3 months and after 12 months
기간: up to 12 months after stroke
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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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up to 12 months after stroke
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Claudio Bassetti, Professor, Universitätsspital Bern (Inselspital) und Universität Bern
- 연구 의자: Carlo Cereda, Capo CLinica, Neurocentre of Southern Switzerland, Ospedale Civico
- 연구 의자: Sebastian Ott, MD, Pneumology, University Hospital, Bern
- 연구 의자: Lino Nobili, Prof. MD, Neurology, Stroke Unit, Ospedale Niguarda, Milan, Italy
- 연구 의자: Mauro Manconi, MD, Neurocentre of Southern Switzerland, Ospedale Civico
- 연구 의자: Peter Young, Prof. MD, Universitätsklinik Münster, Zentrum für Schlafmedizin
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
2010년 7월 1일
기본 완료 (예상)
2016년 4월 1일
연구 완료 (예상)
2016년 4월 1일
연구 등록 날짜
최초 제출
2010년 4월 1일
QC 기준을 충족하는 최초 제출
2010년 4월 1일
처음 게시됨 (추정)
2010년 4월 2일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2015년 10월 26일
QC 기준을 충족하는 마지막 업데이트 제출
2015년 10월 23일
마지막으로 확인됨
2015년 10월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- EOC.NC.10.01
- 320030-125069/1 (기타 보조금/기금 번호: Swiss National Science Foundation (SNSF))
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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