Randomized Intervention With CPAP in Coronary Artery Disease and Sleep Apnea - RICCADSA Trial
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 511
- Locations
- 2
- Primary Endpoint
- The combined rate of cardiovascular mortality, stroke, myocardial infarction and the need for a new revascularization.
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
The combined rate of cardiovascular mortality, stroke, myocardial infarction and the need for a new revascularization.
Time Frame: Three years
Secondary Outcomes
- Cardiovascular biomarkers, left ventricular function, maximal exercise capacity, quality of life, anxiety and depression state.(Three months and one year, respectively.)
Investigators
Yuksel Peker
MD, PhD, Associate Professor
Skaraborg Hospital