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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
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00519597
Acronym
RICCADSA
Enrollment
511
Registered
2007-08-22
Start date
2005-12-31
Completion date
2013-05-31
Last updated
2018-11-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease, Obstructive Sleep Apnea

Keywords

Coronary Artery Disease, Sleep Apnea, CPAP, Revascularization, Mortality

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.

Interventions

DEVICEResMed S8 (Auto-CPAP)

AutoCPAP during sleep

Sponsors

The Swedish Research Council
CollaboratorOTHER_GOV
Swedish Heart Lung Foundation
CollaboratorOTHER
Heart Foundation of Karnsjukhuset Sweden
CollaboratorUNKNOWN
ResMed Foundation
CollaboratorOTHER
Skaraborg Hospital
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
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

Design outcomes

Primary

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

Secondary

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

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 1, 2026