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

Coronary Artery Disease Clinical Trial

— RICCADSA  

Official title:

Randomized Intervention With CPAP in Coronary Artery Disease and Sleep Apnea - RICCADSA Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00519597
• Other study ID #: VGSKAS-4731
• Status: Completed
• Phase: Phase 4
• Start date: December 2005
• Est. completion date: May 2013

Study information

• Verified date: November 2018
• Source: Skaraborg Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 511
• Est. completion date: May 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Device:
• ResMed S8 (Auto-CPAP)
AutoCPAP during sleep

Locations

Country	Name	City	State
Sweden	Skaraborg Hospital	Skövde

Sponsors (5)

Lead Sponsor	Collaborator
Skaraborg Hospital	Heart Foundation of Karnsjukhuset Sweden, ResMed Foundation, Swedish Heart Lung Foundation, The Swedish Research Council

Country where clinical trial is conducted

Sweden, 

References & Publications (12)

Balcan B, Thunström E, Strollo PJ Jr, Peker Y. CPAP Treatment and Depression in Adults with Coronary Artery Disease and Nonsleepy Obstructive Sleep Apnea: A Secondary Analysis of the RICCADSA Trial. Ann Am Thorac Soc. 2018 Aug 21. doi: 10.1513/AnnalsATS.2 — View Citation

Baniak LM, Chasens ER, Luyster FS, Strollo PJ Jr, Thunström E, Peker Y. Obstructive sleep apnea and self-reported functional impairment in revascularized patients with coronary artery disease in the RICCADSA trial. Sleep Breath. 2018 Oct 15. doi: 10.1007/ — View Citation

Glantz H, Johansson MC, Thunström E, Guron CW, Uzel H, Saygin M, Herlitz J, Peker Y. Effect of CPAP on diastolic function in coronary artery disease patients with nonsleepy obstructive sleep apnea: A randomized controlled trial. Int J Cardiol. 2017 Aug 15 — View Citation

Glantz H, Thunström E, Herlitz J, Cederin B, Nasic S, Ejdebäck J, Peker Y. Occurrence and predictors of obstructive sleep apnea in a revascularized coronary artery disease cohort. Ann Am Thorac Soc. 2013 Aug;10(4):350-6. doi: 10.1513/AnnalsATS.201211-106O — View Citation

Glantz H, Thunström E, Johansson MC, Wallentin Guron C, Uzel H, Ejdebäck J, Nasic S, Peker Y. Obstructive sleep apnea is independently associated with worse diastolic function in coronary artery disease. Sleep Med. 2015 Jan;16(1):160-7. doi: 10.1016/j.sle — View Citation

Luyster FS, Strollo PJ Jr, Thunström E, Peker Y. Long-term use of continuous positive airway pressure therapy in coronary artery disease patients with nonsleepy obstructive sleep apnea. Clin Cardiol. 2017 Dec;40(12):1297-1302. doi: 10.1002/clc.22827. Epub — View Citation

Peker Y, Glantz H, Eulenburg C, Wegscheider K, Herlitz J, Thunström E. Effect of Positive Airway Pressure on Cardiovascular Outcomes in Coronary Artery Disease Patients with Nonsleepy Obstructive Sleep Apnea. The RICCADSA Randomized Controlled Trial. Am J — View Citation

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. doi: 10.1080/14017430802 — View Citation

Peker Y, Thunström E, Glantz H, Wegscheider K, Eulenburg C. Outcomes in coronary artery disease patients with sleepy obstructive sleep apnoea on CPAP. Eur Respir J. 2017 Dec 7;50(6). pii: 1700749. doi: 10.1183/13993003.00749-2017. Print 2017 Dec. — View Citation

Peker Y, Wegscheider K, Eulenburg C. Reply: Effect of Continuous Positive Airway Pressure Therapy on Cardiovascular Outcomes: Risk Assessment. Am J Respir Crit Care Med. 2017 Sep 1;196(5):662-663. doi: 10.1164/rccm.201702-0420LE. — View Citation

Thunström E, Glantz H, Fu M, Yucel-Lindberg T, Petzold M, Lindberg K, Peker Y. Increased inflammatory activity in nonobese patients with coronary artery disease and obstructive sleep apnea. Sleep. 2015 Mar 1;38(3):463-71. doi: 10.5665/sleep.4510. — View Citation

Thunström E, Glantz H, Yucel-Lindberg T, Lindberg K, Saygin M, Peker Y. CPAP Does Not Reduce Inflammatory Biomarkers in Patients With Coronary Artery Disease and Nonsleepy Obstructive Sleep Apnea: A Randomized Controlled Trial. Sleep. 2017 Nov 1;40(11). d — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The combined rate of cardiovascular mortality, stroke, myocardial infarction and the need for a new revascularization.		Three years
Secondary	Cardiovascular biomarkers, left ventricular function, maximal exercise capacity, quality of life, anxiety and depression state.		Three months and one year, respectively.