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

This study has been completed.
Sponsor:
Collaborators:
The Swedish Research Council
Swedish Heart Lung Foundation
Heart Foundation of Karnsjukhuset Sweden
ResMed Foundation
Information provided by (Responsible Party):
Yuksel Peker, Skaraborg Hospital
ClinicalTrials.gov Identifier:
NCT00519597
First received: August 20, 2007
Last updated: July 8, 2013
Last verified: July 2013

August 20, 2007
July 8, 2013
December 2005
March 2013   (final data collection date for primary outcome measure)
The combined rate of cardiovascular mortality, stroke, myocardial infarction and the need for a new revascularization. [ Time Frame: Three years ] [ Designated as safety issue: No ]
The combined rate of cardiovascular mortality, stroke, myocardial infarction and the need for a new revascularization. [ Time Frame: Three years ]
Complete list of historical versions of study NCT00519597 on ClinicalTrials.gov Archive Site
Cardiovascular biomarkers, left ventricular function, maximal exercise capacity, quality of life, anxiety and depression state. [ Time Frame: Three months and one year, respectively. ] [ Designated as safety issue: No ]
Cardiovascular biomarkers, left ventricular function, maximal exercise capacity, quality of life, anxiety and depression state. [ Time Frame: Three months and one year, respectively. ]
Not Provided
Not Provided
 
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

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Coronary Artery Disease
  • Obstructive Sleep Apnea
Device: ResMed S8 (Auto-CPAP)
AutoCPAP during sleep
  • Experimental: I
    Asymptomatic OSA (CPAP)
    Intervention: Device: ResMed S8 (Auto-CPAP)
  • No Intervention: II
    Asymptomatic OSA (no CPAP)
  • Active Comparator: III
    Symptomatic OSA (OSAS)
    Intervention: Device: ResMed S8 (Auto-CPAP)
  • No Intervention: IV
    Non-OSA
Peker Y, Glantz H, Thunström E, Kallryd A, Herlitz J, Ejdebäck J. Rationale and design of the Randomized Intervention with CPAP in Coronary Artery Disease and Sleep Apnoea--RICCADSA trial. Scand Cardiovasc J. 2009 Feb;43(1):24-31.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
511
May 2013
March 2013   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Sweden
 
NCT00519597
VGSKAS-4731
Yes
Yuksel Peker, Skaraborg Hospital
Skaraborg Hospital
  • The Swedish Research Council
  • Swedish Heart Lung Foundation
  • Heart Foundation of Karnsjukhuset Sweden
  • ResMed Foundation
Study Chair: Yüksel Peker, Ass. Prof. Skaraborg Hospital and University of Gothenburg
Skaraborg Hospital
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP