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.

Objectives: 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.

Population and methodology: 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.

Trial registration: ClinicalTrials.gov NCT01335087.

Figure 1

Study flow diagram.