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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000032916

Enrollment

100

Registered

2018-07-01

Start date

2018-07-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with stable coronary artery disease and sleep-disordered breathing

Interventions

Continuous positive airway pressure (CPAP) for 12 months no-CPAP for 12 months

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients who have been diagnosed with stable coronary heart disease 2. Patients with 3%ODI >15 events/h 3. Successful PCI for significant coronary stenotic lesion under IVUS guidance 4. Patients having non-calcified plaque with maximal plaque burden > 40% of the non-culprit lesion segment detected by IVUS 5. Patients who agree to be enrolled in the trial, providing signed written informed consent

Exclusion criteria

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
(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.	—

Measure

Time frame

(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.

—

Countries

Japan

Contacts

Public ContactTomotaka Dohi

Juntendo University School of Medicine Department of Cardiovascular Medicine

tdohi@juntendo.ac.jp03-3813-3111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026