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Obstructive sleep apnea (OSA) is an increasingly common chronic disorder in adults. Compared to the general population, OSA occurs more often in patients with coronary artery disease (CAD), with a reported prevalence of 38% to 65%. Emerging evidence indicates OSA initiates and exacerbates coronary atherosclerosis. Moreover, several observational studies indicate the presence of OSA was associated with higher rate of restenosis and repeat revascularization (mainly attributed non-culprit lesion revascularization) after percutaneous coronary intervention (PCI). OSA might initiate endothelial injury by repetitive bursts of sympathetic activity that occur with apneas and hypopneas. Moreover, untreated OSA reduces endothelial repair capacity. Whether OSA could exacerbate neointimal proliferation and plaque progression in the non-culprit lesion after drug-eluting stent (DES) implantation remains less studied. The investigators aimed to evaluate neointimal proliferation and strut coverage within stent segment as well as changes of plaque volume and morphology in the non-culprit lesion by optical coherence tomography (OCT) in patients with versus without OSA at 12-month follow-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OSA |
| ||
| Non-OSA |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OSA | Other | Patients with OSA (apnea hypopnea index ≥15) based on sleep study |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Relative proliferation volume within stent segment (% of stent volume) | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change of total lipid volume index in the non-culprit lesion | 12 months | |
| Maximum area stenosis within stent segment | Defined as minimal lumen area divided by the mean of reference lumen area | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum lipid angle | Baseline | |
| Calcium volume | Baseline | |
| Macrophage volume |
Inclusion Criteria:
Exclusion Criteria:
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Patients undergoing PCI with stenting and 3-vessel OCT and receiving overnight sleep study (polygraphy)
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shao-Ping Nie, MD, PhD | Contact | 86-10-84005256 | spnie@ccmu.edu.cn | |
| Xiao Wang, MD | Contact | 86-10-84005255 | spaceeye123@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Anzhen Hospital, Capital Medical University | Recruiting | Beijing | 100029 | China |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Non-OSA |
| Other |
Patients without OSA (apnea hypopnea index <15) based on sleep study |
|
| Total proliferation volume within stent segment | 12 months |
| Maximum proliferation area within stent segment | 12 months |
| Minimal lumen area within stent segment | 12 months |
| Prevalence of uncovered struts, uncovered and apposed struts, malapposed struts | 12 months |
| Prevalence of neoatherosclerosis | 12 months |
| Total lipid volume index | Defined as the averaged lipid angle multiplied by lipid length; including culprit and non-culprit lesions | Baseline |
| Prevalence of TCFA | In the culprit and non-culprit lesions | Baseline |
| Prevalence of plaque rupture | In the culprit and non-culprit lesions | Baseline |
| Rate of major adverse cardiac events (cardiac death, myocardial infarction, or ischemic-driven repeat revascularization) | 12 months |
| Baseline |
| Correlation of total lipid volume index with AHI | Baseline |
| Correlation of total lipid volume index with lowest SpO2 | Baseline |
| Correlation of total lipid volume index total time with SpO2 <90% | Baseline |
| Total lipid volume index stratified by sex in both groups | Baseline |
| Total lipid volume index stratified by obesity in both groups | Baseline |
| Total lipid volume index stratified by diabetes in both groups | Baseline |
| Rate of individual cardiovascular events | Including all-cause death, cardiac death, myocardial infarction, target vessel revascularization, target lesion revascularization, non-target vessel revascularization, hospitalization for unstable angina | 12 months |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |