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

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ClinicalTrials.gov Identifier: NCT00519597

Recruitment Status : Completed

First Posted : August 22, 2007

Last Update Posted : November 15, 2018

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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

Study Description

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.

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

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 Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	511 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Randomized Intervention With CPAP in Coronary Artery Disease and Sleep Apnea - RICCADSA Trial
Study Start Date :	December 2005
Actual Primary Completion Date :	March 2013
Actual Study Completion Date :	May 2013

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Obstructive sleep apnea

MedlinePlus related topics: Coronary Artery Disease Sleep Apnea

U.S. FDA Resources

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

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

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. ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	Child, Adult, Older Adult
Sexes Eligible for Study:	All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00519597

Locations

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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

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

More Information

Publications of Results:

Baniak LM, Chasens ER, Luyster FS, Strollo PJ Jr, Thunstrom 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 Dec;22(4):1169-1177. doi: 10.1007/s11325-018-1733-4. Epub 2018 Oct 15.

Balcan B, Thunstrom E, Strollo PJ Jr, Peker Y. Continuous Positive Airway Pressure 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. 2019 Jan;16(1):62-70. doi: 10.1513/AnnalsATS.201803-174OC.

Luyster FS, Strollo PJ Jr, Thunstrom 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 2017 Dec 14.

Peker Y, Thunstrom 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):1700749. doi: 10.1183/13993003.00749-2017. Print 2017 Dec.

Thunstrom 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). doi: 10.1093/sleep/zsx157. Erratum In: Sleep. 2019 Feb 1;42(2):

Glantz H, Johansson MC, Thunstrom 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;241:12-18. doi: 10.1016/j.ijcard.2017.03.100. Epub 2017 Mar 25.

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. No abstract available.

Peker Y, Glantz H, Eulenburg C, Wegscheider K, Herlitz J, Thunstrom 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 Respir Crit Care Med. 2016 Sep 1;194(5):613-20. doi: 10.1164/rccm.201601-0088OC.

Glantz H, Thunstrom E, Johansson MC, Wallentin Guron C, Uzel H, Ejdeback 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.sleep.2014.08.018. Epub 2014 Nov 18.

Thunstrom 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.

Glantz H, Thunstrom E, Herlitz J, Cederin B, Nasic S, Ejdeback 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.201211-106OC.

Peker Y, Glantz H, Thunstrom E, Kallryd A, Herlitz J, Ejdeback 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: 10.1080/14017430802276106.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Peker Y, Holtstrand-Hjalm H, Celik Y, Glantz H, Thunstrom E. Postoperative Atrial Fibrillation in Adults with Obstructive Sleep Apnea Undergoing Coronary Artery Bypass Grafting in the RICCADSA Cohort. J Clin Med. 2022 Apr 27;11(9):2459. doi: 10.3390/jcm11092459.

Celik Y, Balcan B, Peker Y. CPAP Intervention as an Add-On Treatment to Lipid-Lowering Medication in Coronary Artery Disease Patients with Obstructive Sleep Apnea in the RICCADSA Trial. J Clin Med. 2022 Jan 5;11(1):273. doi: 10.3390/jcm11010273.

Reynor A, McArdle N, Shenoy B, Dhaliwal SS, Rea SC, Walsh J, Eastwood PR, Maddison K, Hillman DR, Ling I, Keenan BT, Maislin G, Magalang U, Pack AI, Mazzotti DR, Lee CH, Singh B. Continuous positive airway pressure and adverse cardiovascular events in obstructive sleep apnea: are participants of randomized trials representative of sleep clinic patients? Sleep. 2022 Apr 11;45(4):zsab264. doi: 10.1093/sleep/zsab264.

Behboudi A, Thelander T, Yazici D, Celik Y, Yucel-Lindberg T, Thunstrom E, Peker Y. Association of TNF-alpha (-308G/A) Gene Polymorphism with Circulating TNF-alpha Levels and Excessive Daytime Sleepiness in Adults with Coronary Artery Disease and Concomitant Obstructive Sleep Apnea. J Clin Med. 2021 Jul 31;10(15):3413. doi: 10.3390/jcm10153413.

Zinchuk AV, Chu JH, Liang J, Celik Y, Op de Beeck S, Redeker NS, Wellman A, Yaggi HK, Peker Y, Sands SA. Physiological Traits and Adherence to Sleep Apnea Therapy in Individuals with Coronary Artery Disease. Am J Respir Crit Care Med. 2021 Sep 15;204(6):703-712. doi: 10.1164/rccm.202101-0055OC.

Celik Y, Thunstrom E, Strollo PJ Jr, Peker Y. Continuous positive airway pressure treatment and anxiety in adults with coronary artery disease and nonsleepy obstructive sleep apnea in the RICCADSA trial. Sleep Med. 2021 Jan;77:96-103. doi: 10.1016/j.sleep.2020.11.034. Epub 2020 Dec 4.

Peker Y, Thunstrom E, Glantz H, Eulenburg C. Effect of Obstructive Sleep Apnea and CPAP Treatment on Cardiovascular Outcomes in Acute Coronary Syndrome in the RICCADSA Trial. J Clin Med. 2020 Dec 15;9(12):4051. doi: 10.3390/jcm9124051.

Wallstrom S, Balcan B, Thunstrom E, Wolf A, Peker Y. CPAP and Health-Related Quality of Life in Adults With Coronary Artery Disease and Nonsleepy Obstructive Sleep Apnea in the RICCADSA Trial. J Clin Sleep Med. 2019 Sep 15;15(9):1311-1320. doi: 10.5664/jcsm.7926.

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Responsible Party:	Yuksel Peker, MD, PhD, Associate Professor, Skaraborg Hospital
ClinicalTrials.gov Identifier:	NCT00519597
Other Study ID Numbers:	VGSKAS-4731
First Posted:	August 22, 2007 Key Record Dates
Last Update Posted:	November 15, 2018
Last Verified:	November 2018

Keywords provided by Yuksel Peker, Skaraborg Hospital:


Coronary Artery Disease Sleep Apnea CPAP Revascularization Mortality

Additional relevant MeSH terms:

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

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