Impact of Sleep Apnea Syndrome in the Evolution of Acute Coronary Syndrome. Effect of Intervention With Continuous Positive Airway Pressure (CPAP). A Prospective Randomized Study. ISAACC Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,864
- 试验地点
- 2
- 主要终点
- Rate of cardiovascular events in patients with acute coronary syndrome and co-occurring sleep apnea.
研究概览
简要总结
OSA may be a modifiable risk factor for cardiovascular disease due to its association with hypertension, stroke, heart attack and sudden death. The standard therapy for symptomatic OSA is continuous positive airway pressure (CPAP). CPAP has been shown to effectively reduce snoring, obstructive episodes and daytime sleepiness and to modestly reduce blood pressure and other risk factors for cardiovascular disease. The overall aim of ISAACC is to determine if CPAP can reduce the risk of heart attack, stroke or heart failure for people with OSA admitted in a hospital for an acute coronary syndrome.
Overall objective:
To assess the impact of obstructive sleep apnea (OSA) and its treatment on the clinical evolution of patients with acute coronary syndrome (ACS).
Primary objectives:
- To determine if continuous positive airway pressure (CPAP) treatment will reduce the rate of cardiovascular events (cardiovascular (CV) death, non-fatal events (acute myocardial infarction (AMI), non-fatal stroke, hospital admission for heart failure, and new hospitalizations) for unstable angina or transient ischaemic attack (TIA)) in patients with ACS and co-occurring sleep apnea.
Secondary objectives:
- Determine the prevalence of OSA in patients who have suffered an episode of ACS.
- Other secondary objectives will include the effects of CPAP on:
- To evaluate a composite of CV death, myocardial infarction (MI) and ischaemic stroke.
- Components of primary composite endpoints
- Re-vascularization procedures
- To evaluate all-cause death
- To evaluate new onset, ECG-confirmed atrial fibrillation or other arrhythmias
- To evaluate newly diagnosed diabetes mellitus, according to standard definitions
- To evaluate OSA symptoms (Epworth Sleepiness Scale (ESS))
- To evaluate quality of life in patients with ACS (Test EuroQol (EQ-5D).
- To establish the relationship between the severity and phenotype of patients with OSA and clinical outcomes of ACS.
- To establish the relationship between CPAP compliance and CV events incidence.
- To identify biological risk markers that allow us to establish the most important mechanisms involved in cardiovascular complications in these patients.
- To conduct a cost-effectiveness analysis of the diagnosis and CPAP treatment of patients with ACS who have obstructive sleep apnea.
详细描述
Methods:
Study design: multi-centre, open label, parallel, prospective, randomised, controlled trial.
Patients: We will include consecutive patients with an ACS diagnosis evaluated in participating Coronary Care Unit.
Study sites: IRB Lleida (Lleida), Hospital Son Dureta (Palma de Mallorca), Hospital Clínic (Barcelona), Hospital Germans Tries i Pujol (Barcelona), Hospital de Bellvitge (Barcelona), Hospital Sant Pau (Barcelona), Hospital Txagorritxu (Vitoria), Hospital de Cruces (Bilbao), Hospital San Pedro de Alcántara (Cáceres), Hospital Parc Taulí (Barcelona) and Hospital de Guadalajara (Guadalajara), Hospital de Vallecas (Madrid), Hospital de Yagüe (Burgos), Hospital de Requena (Valencia), Hospital San Juan, (Alicante), Hospital Central de Asturias (Oviedo).
Duration of the study: 3 years. Methodology: During a hospital stay we will assess the degree of daytime sleepiness (Epworth Scale) in patients treated at the Coronary Care Unit with a diagnosis of ACS. The results of this evaluation will define the inclusion of the patient in the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women over 18 years old.
- •Patients admitted for documented symptoms of ACS with or without T segment elevation and have an hospital stay between 24h and 72 h in the moment to perform polygraphy .
- •Patients with and Epworth Sleep Scale score ≤ 10 (patients without excessive daytime sleepiness).
- •Written informed consent signed.
排除标准
- •Previous CPAP treatment for OSA diagnosis
- •Psycho-physical inability to complete questionnaires.
- •Presence of any previously diagnosed sleep disorders: narcolepsy, insomnia, chronic sleep deprivation, regular use of hypnotic or sedative medications and restless leg syndrome
- •Patients with > 50% of central apneas or the presence of Cheyne-Stokes Respiration (CSResp)
- •Patients with chronic diseases: neoplasia, renal failure (GFR<30 ml/min), severe chronic obstructive pulmonary disease, chronic depression and other very limiting chronic diseases.
- •A medical history that may interfere with the study objectives or, in the opinion of the investigator, compromise the conclusions.
- •Any medical factor, social or geographical, that may jeopardize patient compliance.(e.g., alcohol consumption (more 80 gr/day in men and more than 60 gr / day in women), no fixed address, disorientation, or a history of non-compliance).
- •Any process, cardiovascular or otherwise, that limits life expectancy to less than one year.
- •Patients in cardiogenic shock who have poor expectations for short-term outcomes.
研究组 & 干预措施
Lifestyle
Standard care for OSA: lifestyle, and sleep hygiene counselling
干预措施: Standard care (Other)
Continuous positive airway pressure CPAP
CPAP treatment every night plus standard care for OSA: lifestyle, and sleep hygiene counselling
干预措施: Standard care (Other)
Continuous positive airway pressure CPAP
CPAP treatment every night plus standard care for OSA: lifestyle, and sleep hygiene counselling
干预措施: continuous positive airway pressure (Device)
Reference
This group will be followed according to cardiovascular protocols and will be evaluated as a reference group.
结局指标
主要结局
Rate of cardiovascular events in patients with acute coronary syndrome and co-occurring sleep apnea.
时间窗: 12 month after the inclusion of the last patient
Cardiovascular events are: cardiovascular death, non-fatal AMI, non-fatal stroke, hospital admission for heart failure, and new hospitalization for unstable angina or TIA.
次要结局
- Prevalence of OSA in patients who have suffered an episode of ACS.(24 month (inclusion period))
- Composite of major CV events(12 month after the inclusion of the last patient)
- Components of primary composite endpoints separately.(12 month after the inclusion of the last patient)
- Number of re-vascularization procedures.(12 month after the inclusion of the last patient)
- All-cause mortality.(12 month after the inclusion of the last patient)
- New onset of ECG-confirmed atrial fibrillation or other arrhythmias.(12 month after the inclusion of the last patient)
- Newly diagnosed diabetes mellitus, according to standard definitions.(12 month after the inclusion of the last patient)
- Epworth Sleepiness Scale (ESS) and Test EuroQol (EQ-5D).(12 month after the inclusion of the last patient)
- Severity and phenotype of patients with OSA and clinical outcomes of ACS.(12 month after the inclusion of the last patient)
- CPAP compliance and CV events incidence.(12 month after the inclusion of the last patient)
- Biological risk markers related to mechanisms involved in cardiovascular complications in these patients.(12 month after the inclusion of the last patient)
- Cost-effectiveness analysis (Qualys) of the diagnosis and CPAP treatment of patients with ACS who have obstructive sleep apnea.(12 month after the inclusion of the last patient)
研究者
Ferran Barbe
MD
Sociedad Española de Neumología y Cirugía Torácica