Ignite Creation Date:
2024-05-05 @ 6:38 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00519597
Status:
COMPLETED
Last Update Posted:
2018-11-15
First Post:
2007-08-20
Brief Title:
Continuous Positive Airway Pressure CPAP Treatment in Coronary Artery Disease and Sleep Apnea
Sponsor:
Skaraborg Hospital
Organization:
Skaraborg Hospital
Study Overview
Official Title:
Randomized Intervention With CPAP in Coronary Artery Disease and Sleep Apnea - RICCADSA Trial
Status:
COMPLETED
Status Verified Date:
2018-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RICCADSA
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 sleepinessSecondary 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
Detailed Description:
Rationale OSA is a common condition in CAD with a poor prognosisMany 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 AHI15 per h without daytime sleepiness Epworth Sleepiness Scale ESS10 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 ESS10 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
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 AHI15 per h without daytime sleepiness Epworth Sleepiness Scale ESS10 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 ESS10 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None