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

NCT04002739 | Unknown

• 1 other identifier: 2589
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

STEMI; NSTEMI; Sleep Apnea; OSA

Outcome Measures

Primary Outcomes (1)

• Evolution of Obstructive Sleep Apnea severity in Acute Coronary Syndrome

  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.

  Baseline, 90 days

Secondary Outcomes (25)

• 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 - EKG Holter

  Baseline

• Predictors of spontaneous reduction of Obstructive Sleep Apnea severity - Bioelectrical impedance

  Baseline, 90 days

• Predictors of spontaneous reduction of Obstructive Sleep Apnea severity - ESS

  Baseline, 90 days

Study Arms (1)

Patients with Acute Coronary Syndrome (ACS)

EXPERIMENTAL

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: Polygraphy

Interventions

Polygraphy 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.

Also known as: VitalNight Plus

Patients with Acute Coronary Syndrome (ACS)

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Roma, 00168, Italy

RECRUITING

Related Links

• "Determinants and evolution of obstructive sleep apnea syndrome after myocardial infarction". The sample size of the trial PROPHET-ACS was derived from this pilot study presented as abstract at the European Sleep and Breathing Conference 2019, Marseille.

MeSH Terms

Conditions

ST Elevation Myocardial Infarction; Sleep Apnea Syndromes; Non-ST Elevated Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Luca Richeldi, PhD

  Fondazione Policlinico Universitario Agostino Gemelli IRCCS

  STUDY DIRECTOR

Central Study Contacts

Pier-Valerio Mari, MD

CONTACT

(+39) 3313881904; piervalerio.mari@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 24, 2019
• First Posted: July 1, 2019
• Study Start: June 15, 2019
• Primary Completion: September 15, 2019
• Study Completion: December 15, 2019
• Last Updated: August 13, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)