Clinical trial NCT04002739: PRedictOrs, PHEnotypes and Timing of Obstructive Sleep Apnea in Acute Coronary Syndrome
Official title: PRedictOrs, PHEnotypes and Timing of Obstructive Sleep Apnea in Acute Coronary Syndrome (PROPHET-ACS)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: ST Elevated Myocardial Infarction
Sleep-Disordered Breathing
Sleep
NSTEMI - Non-ST Segment Elevation MI
Keywords: STEMI
NSTEMI
Sleep Apnea
OSA
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2019-07-01
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The target sample size (for primary aim) is 37. Patients to be enrolled: 50 Patients to be screened: 70

This sample size (n=37) has been defined as sufficient to detect a difference of 15.0 in mean AHI Index between baseline and 3-month follow up with a power of 95% and a 5% (two-sided) significance level. The sample size was calculated and based on a previous pilot study from our institution and reported in "More information" section.

Notably, attrition has been proposed due to the possible loss of follow up at 90-day: thus, we decided to enroll 13 more patients affected by OSA for a total of 50 patients.

Moreover, given a CCU prevalence of OSA in ACS of 73%, a total of 70 patients affected by ACS are expected to be screened in order to collect 50 OSA target sample size population.
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Evolution of Obstructive Sleep Apnea severity in Acute Coronary Syndrome
timeFrame: Baseline, 90 days
Secondary outcomes:
measure: Predictors of spontaneous reduction of Obstructive Sleep Apnea severity - Coronary
timeFrame: Baseline
measure: Predictors of spontaneous reduction of Obstructive Sleep Apnea severity - Echocardiography
timeFrame: Baseline, 90 days
measure: Predictors of spontaneous reduction of Obstructive Sleep Apnea severity - EKG Holter
timeFrame: Baseline
measure: Predictors of spontaneous reduction of Obstructive Sleep Apnea severity - Bioelectrical impedance
timeFrame: Baseline, 90 days
measure: Predictors of spontaneous reduction of Obstructive Sleep Apnea severity - ESS
timeFrame: Baseline, 90 days
measure: Predictors of spontaneous reduction of Obstructive Sleep Apnea severity - STOP-BANG
timeFrame: Baseline, 90 days
measure: Predictors of spontaneous reduction of Obstructive Sleep Apnea severity - Mallampati Score
timeFrame: Baseline
measure: Predictors of spontaneous reduction of Obstructive Sleep Apnea severity - Serological domain
timeFrame: Baseline
measure: Prevalence of Obstructive Sleep Apnea (OSA)
timeFrame: Baseline, 90 days
measure: Evolution of Obstructive Sleep Apnea Syndrome
timeFrame: Baseline, 90 days
measure: Prevalence of Central Sleep Apnea (CSA)
timeFrame: Baseline, 90 days
measure: Evolution of Central Sleep Apnea (CSA)
timeFrame: Baseline, 90 days
measure: Culprit vessel
timeFrame: Baseline
measure: Blood samples characteristics
timeFrame: Baseline
measure: Bioelectrical impedance characteristics
timeFrame: Baseline, 90 days
measure: Evaluation of Ejection Fraction
timeFrame: Baseline, 90 days
measure: Evaluation of Systolic Pulmonary Artery Pressure (SPAP)
timeFrame: Baseline, 90 days
measure: Evolution of Ejection Fraction
timeFrame: Baseline, 90 days
measure: Evolution of Systolic Pulmonary Artery Pressure (SPAP)
timeFrame: Baseline, 90 days
measure: Polysomnographic characteristics
timeFrame: Baseline, 90 days
measure: Evaluation of daytime sleepiness
timeFrame: Baseline, 90 days
measure: Evolution of daytime sleepiness
timeFrame: Baseline, 90 days
measure: Baseline screening of Obstructive Sleep Apnea
timeFrame: Baseline, 90 days
measure: Baseline prediction of Obstructive Sleep Apnea
timeFrame: Baseline
measure: 24 hours-EKG Holter baseline characteristics
timeFrame: Baseline
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study officials:
affiliation: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
name: Luca Richeldi, PhD
role: STUDY_DIRECTOR
References: