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

Coronary Artery Disease Clinical Trial

— VISION  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04022824
• Other study ID #: 2017034
• Status: Recruiting
• Start date: April 18, 2018
• Est. completion date: October 31, 2021

Study information

• Verified date: September 2021
• Source: Beijing Anzhen Hospital
• Contact: Shao-Ping Nie, MD, PhD
• Phone: 86-10-84005256
• Email: spnie[@]ccmu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 84
• Est. completion date: October 31, 2021
• Est. primary completion date: November 12, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. 18 to 80 years old

2. Patients undergoing PCI with stenting in at least one de novo lesion in a native coronary artery

3. 3-vessel OCT was available visually (at least one pullback/vessel)

4. Written informed consent

Exclusion Criteria:

1. Predominantly central sleep apnea (CSA, =50% central events or central apnea hypopnea index =10/h)

2. Previous or current use of continuous positive airway pressure (CPAP)

3. Cardiogenic shock (systolic arterial pressure <90mmHg), congestive heart failure (NYHA or Killip=3)

4. STEMI within 1 week

5. Prior PCI or CABG

6. Chronic kidney disease [eGFR<60ml/(min*1.73m2)]

7. Aortic-coronary ostial lesion

8. Left main lesion

9. Chronic total occlusion

10. In-stent restenotic lesion

11. A tortuous vessel and/or severely calcified lesion or severe stenosis and the OCT catheter could not pass across the lesion

12. Massive residual thrombus on angiography despite thrombus aspiration or thrombectomy

13. Planned elective PCI within 12 months

14. Severe comorbidities: eg. malignancy (life expectancy <2 years)

15. Known or planned pregnancy

Related Conditions & MeSH terms

• Apnea
• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia
• Obstructive Sleep Apnea of Adult
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Other:
• OSA
Patients with OSA (apnea hypopnea index =15) based on sleep study
• Non-OSA
Patients without OSA (apnea hypopnea index <15) based on sleep study

Locations

Country	Name	City	State
China	Beijing Anzhen Hospital, Capital Medical University	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Anzhen Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Maximum lipid angle		Baseline
Other	Calcium volume		Baseline
Other	Macrophage volume		Baseline
Other	Correlation of total lipid volume index with AHI		Baseline
Other	Correlation of total lipid volume index with lowest SpO2		Baseline
Other	Correlation of total lipid volume index total time with SpO2 <90%		Baseline
Other	Total lipid volume index stratified by sex in both groups		Baseline
Other	Total lipid volume index stratified by obesity in both groups		Baseline
Other	Total lipid volume index stratified by diabetes in both groups		Baseline
Other	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
Primary	Relative proliferation volume within stent segment (% of stent volume)		12 months
Secondary	Change of total lipid volume index in the non-culprit lesion		12 months
Secondary	Maximum area stenosis within stent segment	Defined as minimal lumen area divided by the mean of reference lumen area	12 months
Secondary	Total proliferation volume within stent segment		12 months
Secondary	Maximum proliferation area within stent segment		12 months
Secondary	Minimal lumen area within stent segment		12 months
Secondary	Prevalence of uncovered struts, uncovered and apposed struts, malapposed struts		12 months
Secondary	Prevalence of neoatherosclerosis		12 months
Secondary	Total lipid volume index	Defined as the averaged lipid angle multiplied by lipid length; including culprit and non-culprit lesions	Baseline
Secondary	Prevalence of TCFA	In the culprit and non-culprit lesions	Baseline
Secondary	Prevalence of plaque rupture	In the culprit and non-culprit lesions	Baseline
Secondary	Rate of major adverse cardiac events (cardiac death, myocardial infarction, or ischemic-driven repeat revascularization)		12 months