NCT00519597

Continuous Positive Airway Pressure (CPAP) Treatment in Coronary Artery Disease and Sleep Apnea

Randomized Intervention With CPAP in Coronary Artery Disease and Sleep Apnea - RICCADSA Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 511 (actual)
• Sponsor: Skaraborg Hospital · Other Government
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

Obstructive sleep apnea (OSA) worsens the prognosis in patients with coronary artery disease (CAD). Many of these subjects do not report daytime sleepiness, and therefore, are not considered for OSA treatment with continuous positive airway pressure (CPAP). There is lack of evidence regarding the impact of CPAP on the long-term prognosis of CAD patients with OSA. The Randomized Intervention with CPAP in CAD and OSA (RICCADSA) trial is designed to address if CPAP treatment reduces the combined rate of new revascularization, myocardial infarction, stroke and cardiovascular mortality over mean follow-up period of 3-years in CAD patients with OSA without daytime sleepiness.Secondary outcomes include cardiovascular biomarkers, cardiac function, maximal exercise capacity and quality of life at baseline, 3-month- and 1-year follow-up as well as polysomnographic findings and adherence to CPAP therapy.

Detailed description

Rationale: OSA is a common condition in CAD with a poor prognosis.Many of these subjects do not report daytime sleepiness, and therefore, are not considered for OSA treatment with CPAP. There is lack of evidence regarding the impact of CPAP on the long-term prognosis of CAD patients with OSA. Objective: The RICCADSA trial is designed to address if CPAP treatment reduces the combined rate of new revascularization, myocardial infarction, stroke and cardiovascular mortality over a mean follow-up period of 3-years in CAD patients with OSA (Apnea-Hypopnea-Index \[AHI\]\>=15 per h) without daytime sleepiness (Epworth Sleepiness Scale \[ESS\]\<10). Secondary outcomes include cardiovascular biomarkers, cardiac function, maximal exercise capacity and quality of life at baseline, 3-month- and 1-year follow-up as well as polysomnographic findings and adherence to CPAP therapy. Patients and Methods: A sample of 511 CAD patients (122 non-sleepy OSA patients randomized to CPAP, 122 to non-CPAP; 155 sleepy OSA patients \[ESS\>=10\] on CPAP, and 112 CAD patients without OSA \[AHI \<5 per h\]) were included. The trial has 80% power to detect a risk reduction from an assumed composite end-point rate of 25% to 12% for the primary outcome at intention-to-treat basis.

Conditions

• Coronary Artery Disease
• Obstructive Sleep Apnea

Interventions

Type	Name	Description
DEVICE	ResMed S8 (Auto-CPAP)	AutoCPAP during sleep

Timeline

• Start date: 2005-12-01
• Primary completion: 2013-03-01
• Completion: 2013-05-01
• First posted: 2007-08-22
• Last updated: 2018-11-15

Locations

1 site across 1 country: Sweden