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

Phase 4

Completed

• Conditions: Coronary Artery Disease; Obstructive Sleep Apnea
• Interventions: Device: ResMed S8 (Auto-CPAP)

• Registration Number: NCT00519597
• Lead Sponsor: Skaraborg Hospital

Brief 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.

Study Timeline

• Study Start: 2005-12
• Study First Submitted: 2007-08-20
• Study First Submitted QC: 2007-08-20
• Study First Posted: 2007-08-22
• Primary Completion: 2013-03
• Study Completion: 2013-05
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-13
• Last Update Posted: 2018-11-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 511

Inclusion Criteria

• Patients with angiographically-verified CAD who have newly undergone PCI or CABG treatment
• Written, informed study consent
• OSA (AHI>=15 per hour) or non-OSA (AHI<5 per hour) diagnosis on the unattended sleep recording at home

Exclusion Criteria

• Patients with already treated OSAS
• Patients presenting mainly central apneas (Cheynes-Stokes breathing)
• Patients with borderline OSA (AHI <15 and >=5 per hour) upon the unattended sleep recording at home

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
I	ResMed S8 (Auto-CPAP)	Asymptomatic OSA (CPAP)
III	ResMed S8 (Auto-CPAP)	Symptomatic OSA (OSAS)

Primary Outcome Measures

Name	Time	Method
The combined rate of cardiovascular mortality, stroke, myocardial infarction and the need for a new revascularization.	Three years

Secondary Outcome Measures

Name	Time	Method
Cardiovascular biomarkers, left ventricular function, maximal exercise capacity, quality of life, anxiety and depression state.	Three months and one year, respectively.

Trial Locations

Locations (1)

Skaraborg Hospital; 🇸🇪 Skövde, Sweden