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

Skaraborg Hospital

Status and phase: Completed; Phase 4

Conditions: Coronary Artery Disease; Obstructive Sleep Apnea

Treatments: Device: ResMed S8 (Auto-CPAP)

Study type: Interventional

Funder types: Other

Identifiers

NCT00519597

VGSKAS-4731

Details and patient eligibility

About

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.

Full 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.

Enrollment: 511 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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511 participants in 4 patient groups

I

Experimental group

Description:

Asymptomatic OSA (CPAP)

Treatment:

Device: ResMed S8 (Auto-CPAP)

II

No Intervention group

Description:

Asymptomatic OSA (no CPAP)

III

Active Comparator group

Description:

Symptomatic OSA (OSAS)

Treatment:

Device: ResMed S8 (Auto-CPAP)

IV

No Intervention group

Description:

Non-OSA