NCT04022824

Vascular Responses After Percutaneous Coronary Intervention With Stenting In Patients With Obstructive Sleep Apnea

Vascular Responses After Percutaneous Coronary Intervention With Stenting In Patients With Obstructive Sleep ApNea: A Serial 3-Vessel Optical Coherence Tomography Study (VISION)

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 84 (estimated)
• Sponsor: Beijing Anzhen Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Coronary Artery Disease
• Obstructive Sleep Apnea of Adult

Interventions

Type	Name	Description
OTHER	OSA	Patients with OSA (apnea hypopnea index ≥15) based on sleep study
OTHER	Non-OSA	Patients without OSA (apnea hypopnea index \<15) based on sleep study

Timeline

• Start date: 2018-04-18
• Primary completion: 2019-11-12
• Completion: 2021-10-31
• First posted: 2019-07-17
• Last updated: 2021-09-05

Locations

1 site across 1 country: China