PRedictOrs, PHEnotypes and Timing of Obstructive Sleep Apnea in Acute Coronary Syndrome

NCT ID: NCT04002739

Last Updated: 2019-08-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-15
• Study Completion Date: 2019-12-15

Brief Summary

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.

Detailed 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.

Conditions

ST Elevated Myocardial Infarction; Sleep-Disordered Breathing; Sleep; NSTEMI - Non-ST Segment Elevation MI

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Polygraphy

Intervention Type: DIAGNOSTIC_TEST

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.

Interventions

Polygraphy

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.

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

VitalNight Plus

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Luca Richeldi, PhD

Role: STUDY_DIRECTOR

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Locations

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Roma, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Pier-Valerio Mari, MD

Role: CONTACT

piervalerio.mari@gmail.com

(+39) 3313881904

Facility Contacts

Pier-Valerio Mari, MD

Role: primary

piervalerio.mari@gmail.com

(+39) 3313881904

Other Identifiers

2589

Identifier Type: -

Identifier Source: org_study_id