title: Rationale and methodology of the impact of continuous positive airway pressure on patients with ACS and nonsleepy OSA: the ISAACC Trial.
abstract: BACKGROUND
  Obstructive sleep apnea (OSA) is common in acute coronary syndrome (ACS) and a possible cause of increased morbidity and mortality.
  
  
  OBJECTIVE
  The main objective is to determine in patients with ACS and OSA if CPAP treatment reduces the incidence of cardiovascular events (cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, hospitalization for heart failure, and hospitalization for unstable angina or transient ischemic attack). The secondary objectives are to determine the prevalence of nonsleepy OSA in patients with ACS; assess the effect of CPAP on the incidence of newly diagnosed diabetes mellitus, symptoms, and quality of life; identify biomarkers of risk involved in cardiovascular complications in these patients; and conduct a cost-effectiveness analysis of diagnosis and treatment.
  
  
  METHODS
  Multicenter, prospective, randomized and controlled study. Patients are admitted to the coronary care unit with diagnosis of ACS and without daytime sleepiness (Epworth Sleepiness Scale ≤10) at 15 teaching hospitals in Spain. All patients undergo a sleep study by cardiorespiratory polygraphy. Patients with an apnea-hypopnea index ≥15/hour will be randomized to treatment with CPAP (group 1, 632 patients) or conservative treatment (group 2, 632 patients). Patients with an apnea-hypopnea index <15/hour (group 3, 600 patients) will be followed as a reference group. Patients will be monitored at baseline (T0), 1 month (T1), 3 months (T2), 6 months (T3), 12 months (T4), and every 6 months thereafter (where applicable) during the follow-up period.
  
  
  CONCLUSIONS
  The ISAACC trial will contribute to evaluating the effect of CPAP treatment on cardiovascular events in patients with ACS and OSA.
authors.affiliation: Respiratory Department, Hospital Universitari Arnau de Vilanova-Santa Maria, Lleida, Spain; Respiratory Medicine Research Group, IRBLleida, Lleida, Spain.
authors.forename: Cristina
authors.initials: C
authors.lastname: Esquinas
authors.forename: Manuel
authors.initials: M
authors.lastname: Sánchez-de-la Torre
authors.forename: Albina
authors.initials: A
authors.lastname: Aldomá
authors.forename: Marina
authors.initials: M
authors.lastname: Florés
authors.forename: Montserrat
authors.initials: M
authors.lastname: Martínez
authors.forename: Antonia
authors.initials: A
authors.lastname: Barceló
authors.forename: Ferran
authors.initials: F
authors.lastname: Barbé
mesh_terms: D054058:Acute Coronary Syndrome / Q000150:complications* / Q000401:mortality / Q000628:therapy; D000328:Adult; D000368:Aged; D045422:Continuous Positive Airway Pressure / Q000379:methods*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D015994:Incidence; D008297:Male; D008875:Middle Aged; D010349:Patient Compliance; D011446:Prospective Studies; D020181:Sleep Apnea, Obstructive / Q000453:epidemiology / Q000209:etiology / Q000628:therapy*; D013030:Spain / Q000453:epidemiology; D015996:Survival Rate / Q000639:trends; D016896:Treatment Outcome