CPAP Effects on Atherosclerotic Plaques in Patients with Sleep-Disordered Breathing and Coronary Artery Disease

Not Applicable

Recruiting

• Conditions: Patients with stable coronary artery disease and sleep-disordered breathing

• Registration Number: JPRN-UMIN000032916
• Lead Sponsor: Department of Cardiovascular Medicine, Juntendo University School of Medicine, Tokyo, Japan

Brief Summary

Finally, the CPAP group (n=23) and non-CPAP group (n=24) were analyzed. Compared to the non-CPAP group, the CPAP group had a significantly decreased percentage atheroma volume (adjusted difference -2.81+/-1.10%, p=0.014) by analysis of covariance, and tended to have a lower incidence rate of MACCE, mainly driven by a decrease in target vessel revascularization (4% vs. 25%, p=0.097).

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-07-01
• Study Completion: 2022-03-31
• Last Update Posted: 1 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 47

Inclusion Criteria

Not provided

Exclusion Criteria

1. Patients treated with CPAP therapy 2. Patients with hypersomnia requiring urgent treatment (defined as an Epworth Sleepiness Scale [ESS] score >18) 3. Patients over 75 years of age 4. Patients with New York Heart Association class II, III, or IV heart failure 5. Patients with renal insufficiency (serum creatinine 2.0 mg/dL) 6. Patients with hemodialysis 7. Patients with malignant disease 8. Patients recognized as inadequate by attending physician

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage changes in plaque atheroma volume in the non-culprit lesion measured by IVUS from baseline to 12 months

Secondary Outcome Measures

Name	Time	Method
(1) Absolute changes in maxLCBI4mm and maxLCBI10mm in the non-culprit lesion segment by NIRS analysis from baseline to 12 months (2) Absolute change in total atheroma volume in the non-culprit lesion measured by IVUS from baseline to 12 months (3) Absolute change in serum high-sensitivity C-reactive protein level from baseline to 12 months (4) Major adverse cardiac and cerebrovascular events, defined as composite of cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, hospitalization for unstable angina, target vessel revascularization including target lesion revascularization and non-target lesion target vessel revascularization and hospitalization for congestive heart failure, and all-cause death during the follow-up period.