Sleep study-guided multidisciplinary therapy (SGMT) for patients with acute coronary syndrome: Trial rationale and design.

Obstructive sleep apnea (OSA) is an emerging risk marker for acute coronary syndrome (ACS). This randomized trial aims to determine the effects of sleep study-guided multidisciplinary therapy (SGMT) comprising overnight sleep study, continuous positive airway pressure, and behavioral therapy for OSA during the subacute phase of ACS. We hypothesize that SGMT will reduce (1) the plasma levels of N-terminal pro brain natriuretic peptide and suppression of tumorigenicity 2; (2) the estimated 10-year risk of cardiovascular mortality as measured by the European Systematic Coronary Risk Evaluation (SCORE) algorithm; and (3) the cardiovascular event rate during a 3-year follow-up, compared with standard therapy. In the SGMT trial, 180 patients presenting with ACS will be randomly assigned to SGMT (n = 90) and standard therapy (n = 90) groups. Both groups will receive guideline-mandated treatment for ACS. Those assigned to SGMT will additionally undergo a sleep study and, if OSA is diagnosed, attend a multidisciplinary OSA clinic where they will receive personalized treatment including continuous positive airway pressure and behavioral/lifestyle counseling. The primary endpoint is the plasma N-terminal pro brain natriuretic peptide concentration at 7-month follow-up. This report presents the baseline characteristics of 117 patients (SGMT group: n =54; standard therapy group: n =63) who had been enrolled into the study as of August 31, 2017. The results of this trial will help us to understand whether active OSA diagnosis and treatment will improve the physiologic and clinical cardiovascular outcomes of this group of patients.

RCT Entities:   Population Interventions Outcomes