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
  Purpose

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.


Condition Intervention Phase
Coronary Artery Disease
Obstructive Sleep Apnea
Device: ResMed S8 (Auto-CPAP)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Intervention With CPAP in Coronary Artery Disease and Sleep Apnea - RICCADSA Trial

Resource links provided by NLM:


Further study details as provided by Skaraborg Hospital:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 511
Study Start Date: December 2005
Study Completion Date: May 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: I
Asymptomatic OSA (CPAP)
Device: ResMed S8 (Auto-CPAP)
AutoCPAP during sleep
No Intervention: II
Asymptomatic OSA (no CPAP)
Active Comparator: III
Symptomatic OSA (OSAS)
Device: ResMed S8 (Auto-CPAP)
AutoCPAP during sleep
No Intervention: IV
Non-OSA

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00519597

Locations
Sweden
Skaraborg Hospital
Skövde, Sweden, 54185
Sponsors and Collaborators
Skaraborg Hospital
The Swedish Research Council
Swedish Heart Lung Foundation
Heart Foundation of Karnsjukhuset Sweden
ResMed Foundation
Investigators
Study Chair: Yüksel Peker, Ass. Prof. Skaraborg Hospital and University of Gothenburg
  More Information

Publications:
Responsible Party: Yuksel Peker, MD, PhD, Associate Professor, Skaraborg Hospital
ClinicalTrials.gov Identifier: NCT00519597     History of Changes
Other Study ID Numbers: VGSKAS-4731
Study First Received: August 20, 2007
Last Updated: July 8, 2013
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by Skaraborg Hospital:
Coronary Artery Disease
Sleep Apnea
CPAP
Revascularization
Mortality

Additional relevant MeSH terms:
Apnea
Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Dyssomnias
Heart Diseases
Nervous System Diseases
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms
Signs and Symptoms, Respiratory
Sleep Disorders
Sleep Disorders, Intrinsic
Vascular Diseases

ClinicalTrials.gov processed this record on October 22, 2014