PRedictOrs, PHEnotypes and Timing of Obstructive Sleep Apnea in Acute Coronary Syndrome (PROPHET-ACS)
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Evolution of Obstructive Sleep Apnea severity in Acute Coronary Syndrome
研究概览
简要总结
Obstructive Sleep Apnea (OSA) is a well-known disorder of upper airways collapse during sleep time leading to oxygen desaturation and sleep fragmentation. Despite being increasingly recognized as cardiovascular risk, the effect of OSA on clinical outcomes after Acute Coronary Syndrome (ACS) is not fully defined. Also, OSA syndrome is highly prevalent in ACS and may be related to the deterioration of cardiac function resulting in worsening of the severity of sleep apnea or the intermittent hypoxia could be cardio-protective via the ischemic preconditioning event. Serial sleep studies have shown the progressive reduction of the Apnea / Hypopnea Index (AHI) from the admission in Coronary Care Unit (CCU) to 6 weeks, 12 weeks and 6-month follow up, making necessary to re-assess the severity of OSA after discharge. Therefore, further research in this field is necessary to screen and predict those ACS patients who may experience a change in their AHI index over time.
详细描述
Obstructive Sleep Apnea (OSA) is a well-known disorder of upper airways collapse during sleep time leading to oxygen desaturation, sleep fragmentation, tissue suffering and hypercapnia. The repeated airways collapse leads to a fall of blood saturation levels during sleep time and it is linked to daytime sleepiness, road traffic accidents, cognitive deficits, depression, myocardial infarction, pulmonary hypertension and stroke.
Despite being increasingly recognized as a major cardiovascular risk, the effect of OSA on clinical outcomes after Coronary Artery Disease (CAD) is not fully defined. The presentation of Acute Coronary Syndrome (ACS) can be unstable angina, non-ST Elevation Myocardial Infarction (NSTEMI) or ST-Elevation Myocardial Infarction (STEMI). Sleep apnea prevalence in the context of acute coronary syndromes (ACS) is sizeable, varying from 36.9%-82% when polysomnography is executed briefly after admission in Cardiovascular Care Unit (CCU). The high prevalence of OSA in ACS may be related to the deterioration of cardiac function resulting in worsening of the severity of sleep apnea. In converse, OSA has also been proposed as a protective factor in CAD. The intermittent hypoxia related to OSA could have a cardio-protective role during acute ACS via the phenomenon of "ischemic preconditioning", showing that in acute MI patients higher AHI was associated with lower peak troponin-T levels in partially and fully adjusted models.
Furthermore, the improvement of cardiac outcomes at the follow-up post-discharge seems to positively influence the severity of OSA. In particular, serial sleep studies have interestingly shown a progressive reduction of the AHI at 6 weeks, 12 weeks and 6-month follow up, making necessary to re-assess the severity of OSA after discharge. Therefore, further research in this field is necessary to screen and predict those ACS patients with a diagnosis of OSA made at admission in CCU who may experience a change in their AHI index over time, in order to identify those with a potential unfavourable prognosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with a diagnosis of ACS (STEMI or NSTEMI) admitted to CCU of our institution within 72 hours from Myocardial Infarct (MI)
- •Age between 18 and 85 years old
排除标准
- •Previous diagnosis of OSA or ongoing CPAP treatment
- •Chronic/Home Oxygen therapy
- •Cardiogenic shock
- •Heart failure exacerbation
- •use of mechanical ventilation
- •Active use of benzodiazepines
- •Pregnancy or breastfeeding
- •Unable to sign the informed consent
研究组 & 干预措施
Patients with Acute Coronary Syndrome (ACS)
Patients admitted to a Coronary Care Unit (CCU) with a new diagnosis of ST Elevation Myocardial Infarction (STEMI) or Non ST Elevation Myocardial Infarction (NSTEMI). Patients are eligible within 72 hours from the admission in CCU. All patients admitted to CCU are going to perform the following procedures/exams as standard clinical practice: coronary angiogram, blood samples, echocardiogram, 24-hour Holter EKG Monitoring. The experimental arm will also perform a polygraphy during CCU stay, a bioelectrical impedance and will complete baseline questionnaires assessing daytime sleepiness such as Epworth Sleepiness Scale (ESS), STOP-BANG and Mallampati score. After the discharge from CCU, patients that had a diagnosis of Obstructive Sleep Apnea Syndrome are going to complete a follow up visit in 90 days undergoing a new polygraphy, bioelectrical impedance, questionnaires (ESS, STOP-BANG and Mallampati Score), echocardiogram.
干预措施: Polygraphy (Diagnostic Test)
结局指标
主要结局
Evolution of Obstructive Sleep Apnea severity in Acute Coronary Syndrome
时间窗: Baseline, 90 days
Change of Obstructive Sleep Apnea (OSA) severity from baseline to 90 days in patients affected by an Acute Coronary Syndrome (ACS). Within 72 hours from admission, patients will perform a polygraphy and the Apnea / Hypopnea Index (AHI) will be determined. OSA syndrome is defined by AHI more than 5.0 per hour and can be mild (AHI between 5.0 and 15), moderate (AHI between 15.0 and 30.0) or severe (AHI more than 30.0). When a diagnosis of OSA is confirmed, the patient will have a follow up visit with a new polygraphy and AHI will be defined again. Patients are not going to receive any treatment for the sleep-disorder breathing between baseline and 90-day. The difference between AHI baseline and AHI of the follow-up will define the evolution of OSA severity and will show an improved, stable or worsened sleep-disorder.
次要结局
- Predictors of spontaneous reduction of Obstructive Sleep Apnea severity - ESS(Baseline, 90 days)
- Blood samples characteristics(Baseline)
- Bioelectrical impedance characteristics(Baseline, 90 days)
- Predictors of spontaneous reduction of Obstructive Sleep Apnea severity - Coronary(Baseline)
- Predictors of spontaneous reduction of Obstructive Sleep Apnea severity - Echocardiography(Baseline, 90 days)
- Predictors of spontaneous reduction of Obstructive Sleep Apnea severity - STOP-BANG(Baseline, 90 days)
- Culprit vessel(Baseline)
- Predictors of spontaneous reduction of Obstructive Sleep Apnea severity - EKG Holter(Baseline)
- Predictors of spontaneous reduction of Obstructive Sleep Apnea severity - Bioelectrical impedance(Baseline, 90 days)
- Prevalence of Obstructive Sleep Apnea (OSA)(Baseline, 90 days)
- Evolution of Central Sleep Apnea (CSA)(Baseline, 90 days)
- Predictors of spontaneous reduction of Obstructive Sleep Apnea severity - Serological domain(Baseline)
- Prevalence of Central Sleep Apnea (CSA)(Baseline, 90 days)
- Evaluation of Systolic Pulmonary Artery Pressure (SPAP)(Baseline, 90 days)
- 24 hours-EKG Holter baseline characteristics(Baseline)
- Predictors of spontaneous reduction of Obstructive Sleep Apnea severity - Mallampati Score(Baseline)
- Evolution of Obstructive Sleep Apnea Syndrome(Baseline, 90 days)
- Evolution of daytime sleepiness(Baseline, 90 days)
- Baseline screening of Obstructive Sleep Apnea(Baseline, 90 days)
- Evaluation of Ejection Fraction(Baseline, 90 days)
- Evaluation of daytime sleepiness(Baseline, 90 days)
- Baseline prediction of Obstructive Sleep Apnea(Baseline)
- Evolution of Systolic Pulmonary Artery Pressure (SPAP)(Baseline, 90 days)
- Evolution of Ejection Fraction(Baseline, 90 days)
- Polysomnographic characteristics(Baseline, 90 days)