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

November 13, 2018 updated by: Yuksel Peker, Skaraborg Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

511

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Skövde, Sweden, 54185
        • Skaraborg Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The combined rate of cardiovascular mortality, stroke, myocardial infarction and the need for a new revascularization.
Time Frame: Three years
Three years

Secondary Outcome Measures

Outcome Measure
Time Frame
Cardiovascular biomarkers, left ventricular function, maximal exercise capacity, quality of life, anxiety and depression state.
Time Frame: Three months and one year, respectively.
Three months and one year, respectively.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Skaraborg Hospital

Collaborators

The Swedish Research Council
Swedish Heart Lung Foundation
ResMed Foundation
Heart Foundation of Karnsjukhuset Sweden

Investigators

  • Study Chair: Yüksel Peker, Ass. Prof., Göteborg University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2005

Primary Completion (Actual)

March 1, 2013

Study Completion (Actual)

May 1, 2013

Study Registration Dates

First Submitted

August 20, 2007

First Submitted That Met QC Criteria

August 20, 2007

First Posted (Estimate)

August 22, 2007

Study Record Updates

Last Update Posted (Actual)

November 15, 2018

Last Update Submitted That Met QC Criteria

November 13, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VGSKAS-4731

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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