ENTERPRISE

Not Applicable

• Conditions: Patients with stable coronary artery disease and sleep-disordered breathing; Plaque progression and regression

• Registration Number: JPRN-jRCTs032180281
• Lead Sponsor: Dohi Tomotaka

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-03-14
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. Patients over 20 years of age and under 75 years of age
2. Patients who have been diagnosed with stable coronary heart disease
3. Patients with 3%ODI >15 events/h
4. Successful PCI for significant coronary stenotic lesion under IVUS guidance and 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 standing after having received enough explanation on participating to this study at the agreement acquisition.

Exclusion Criteria

1.Patients under 20 years of age and over 75 years of age
2.Patients who have been required coronary bypass surgery
3.Patients with malignant disease who have been required to chemotherapy
4.Patients who have been required to be treated with invasive surgery
5.Patients with renal insufficiency (serum creatinine >2.0 mg/dL) or with hemodialysis
6.Patients with respiratory failure who have been required oxygen therapy
7.Patients treated with CPAP therapy
8.Patients with New York Heart Association class II, III, or IV heart failure
9.Patients with hypersomnia requiring urgent treatment (defined as an Epworth Sleepiness Scale [ESS] score=>18)
10.Patients recognized as inadequate by attending physician

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percent change in plaque volume of non-culprit coronary lesion segment

Secondary Outcome Measures

Name	Time	Method
As a secondary measure, the extent of lipid-rich plaque by NIRS, absolute change in plaque volume by IVUS and change in hs-CRP level will be assessed. Other secondary outcomes will be adverse clinical events including cardiovascular death, nonfatal MI, nonfatal stroke, hospitalization for unstable angina, target lesion revascularization (TLR), nontarget lesion target vessel revascularization (non-TL TVR), or hospitalization for congestive heart failure.