Continuous Positive Airway Pressure (CPAP) in Patients With Acute Coronary Syndrome and Obstructive Sleep Apnea (OSA)

Summary

OSA may be a modifiable risk factor for cardiovascular disease due to its association with hypertension, stroke, heart attack and sudden death. The standard therapy for symptomatic OSA is continuous positive airway pressure (CPAP). CPAP has been shown to effectively reduce snoring, obstructive episodes and daytime sleepiness and to modestly reduce blood pressure and other risk factors for cardiovascular disease. The overall aim of ISAACC is to determine if CPAP can reduce the risk of heart attack, stroke or heart failure for people with OSA admitted in a hospital for an acute coronary syndrome.

Overall objective:

To assess the impact of obstructive sleep apnea (OSA) and its treatment on the clinical evolution of patients with acute coronary syndrome (ACS).

Primary objectives:

1\. To determine if continuous positive airway pressure (CPAP) treatment will reduce the rate of cardiovascular events (cardiovascular (CV) death, non-fatal events (acute myocardial infarction (AMI), non-fatal stroke, hospital admission for heart failure, and new hospitalizations) for unstable angina or transient ischaemic attack (TIA)) in patients with ACS and co-occurring sleep apnea.

Secondary objectives:

1. Determine the prevalence of OSA in patients who have suffered an episode of ACS.
2. Other secondary objectives will include the effects of CPAP on:

* To evaluate a composite of CV death, myocardial infarction (MI) and ischaemic stroke.
* Components of primary composite endpoints
* Re-vascularization procedures
* To evaluate all-cause death
* To evaluate new onset, ECG-confirmed atrial fibrillation or other arrhythmias
* To evaluate newly diagnosed diabetes mellitus, according to standard definitions
* To evaluate OSA symptoms (Epworth Sleepiness Scale (ESS))
* To evaluate quality of life in patients with ACS (Test EuroQol (EQ-5D).
3. To establish the relationship between the severity and phenotype of patients with OSA and clinical outcomes of ACS.
4. To establish the relationship between CPAP compliance and CV events incidence.
5. To identify biological risk markers that allow us to establish the most important mechanisms involved in cardiovascular complications in these patients.
6. To conduct a cost-effectiveness analysis of the diagnosis and CPAP treatment of patients with ACS who have obstructive sleep apnea.

Conditions

• Acute Coronary Syndrome
• Obstructive Sleep Apnea

Interventions

OTHER

Standard care

Patients with conservative treatment: (Group 2). This group will also be instructed in hygienic-dietary measures, standard care of cardiovascular risk factors and sleep hygiene counselling.

DEVICE

continuous positive airway pressure

Patients with CPAP treatment (Group 1): CPAP pressure titration will be performed by automated equipment before discharge. It will follow the methodology described by our group (Mass et al. Alternative Methods of titrating continuous positive airway pressure: a large multicentre study. American Journal of Respiratory and Critical Care Medicine (2004) vol. 170 (11) pp. 1218-1224). This group will also be instructed in hygienic-dietary measures recommended for all patients, standard care of cardiovascular risk factors and sleep hygiene counselling.

Sponsors & Collaborators

• ResMed

  collaborator INDUSTRY

• Fondo de Investigacion Sanitaria

  collaborator OTHER

• EsteveTeijin Healthcare

  collaborator OTHER

• Spanish Society of Cardiology

  collaborator OTHER

• Sociedad Madrileña de Neumologia

  collaborator UNKNOWN

• Sociedad Española de Neumología y Cirugía Torácica

  lead OTHER

Principal Investigators

• Ferran Barbe, MD · Spanish Respiratory Sociey

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-04-30

Primary Completion

2018-09-30

Completion

2018-09-30

Countries

• Spain

Study Locations