PRedictOrs, PHEnotypes and Timing of Obstructive Sleep Apnea in Acute Coronary Syndrome
Keywords
Abstract
Description
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.
Dates
Last Verified: | 07/31/2019 |
First Submitted: | 06/23/2019 |
Estimated Enrollment Submitted: | 06/25/2019 |
First Posted: | 06/30/2019 |
Last Update Submitted: | 08/08/2019 |
Last Update Posted: | 08/12/2019 |
Actual Study Start Date: | 06/14/2019 |
Estimated Primary Completion Date: | 09/14/2019 |
Estimated Study Completion Date: | 12/14/2019 |
Condition or disease
Intervention/treatment
Diagnostic Test: Patients with Acute Coronary Syndrome (ACS)
Phase
Arm Groups
Arm | Intervention/treatment |
---|---|
Experimental: 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. | Diagnostic Test: Patients with Acute Coronary Syndrome (ACS) Patients will perform polygraphy during the CCU stay (baseline) and, if found to have a diagnosis of Obstructive Sleep Apnea (OSA) syndrome, will complete the study with a follow-up visit at 90-day (follow-up). Diagnosis of OSA syndrome will require an Apnea / Hypopnea Index (AHI) more than 5 events per hour. |
Eligibility Criteria
Ages Eligible for Study | 18 Years To 18 Years |
Sexes Eligible for Study | All |
Accepts Healthy Volunteers | Yes |
Criteria | Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
Outcome
Primary Outcome Measures
1. Evolution of Obstructive Sleep Apnea severity in Acute Coronary Syndrome [Baseline, 90 days]
Secondary Outcome Measures
1. Predictors of spontaneous reduction of Obstructive Sleep Apnea severity - Coronary [Baseline]
2. Predictors of spontaneous reduction of Obstructive Sleep Apnea severity - Echocardiography [Baseline, 90 days]
3. Predictors of spontaneous reduction of Obstructive Sleep Apnea severity - EKG Holter [Baseline]
4. Predictors of spontaneous reduction of Obstructive Sleep Apnea severity - Bioelectrical impedance [Baseline, 90 days]
5. Predictors of spontaneous reduction of Obstructive Sleep Apnea severity - ESS [Baseline, 90 days]
6. Predictors of spontaneous reduction of Obstructive Sleep Apnea severity - STOP-BANG [Baseline, 90 days]
7. Predictors of spontaneous reduction of Obstructive Sleep Apnea severity - Mallampati Score [Baseline]
8. Predictors of spontaneous reduction of Obstructive Sleep Apnea severity - Serological domain [Baseline]
9. Prevalence of Obstructive Sleep Apnea (OSA) [Baseline, 90 days]
10. Evolution of Obstructive Sleep Apnea Syndrome [Baseline, 90 days]
11. Prevalence of Central Sleep Apnea (CSA) [Baseline, 90 days]
12. Evolution of Central Sleep Apnea (CSA) [Baseline, 90 days]
13. Culprit vessel [Baseline]
14. Blood samples characteristics [Baseline]
15. Bioelectrical impedance characteristics [Baseline, 90 days]
16. Evaluation of Ejection Fraction [Baseline, 90 days]
17. Evaluation of Systolic Pulmonary Artery Pressure (SPAP) [Baseline, 90 days]
18. Evolution of Ejection Fraction [Baseline, 90 days]
19. Evolution of Systolic Pulmonary Artery Pressure (SPAP) [Baseline, 90 days]
20. Polysomnographic characteristics [Baseline, 90 days]
21. Evaluation of daytime sleepiness [Baseline, 90 days]
22. Evolution of daytime sleepiness [Baseline, 90 days]
23. Baseline screening of Obstructive Sleep Apnea [Baseline, 90 days]
24. Baseline prediction of Obstructive Sleep Apnea [Baseline]
25. 24 hours-EKG Holter baseline characteristics [Baseline]
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