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

NCT04022824 | Unknown

• 1 other identifier: 2017034
• Study Type: observational
• Target: 84
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Coronary artery disease; Obstructive sleep apnea; Optical coherence tomography; Vascular response

Outcome Measures

Primary Outcomes (1)

• Relative proliferation volume within stent segment (% of stent volume)

  12 months

Secondary Outcomes (11)

• Change of total lipid volume index in the non-culprit lesion

  12 months

• Maximum area stenosis within stent segment

  12 months

• Total proliferation volume within stent segment

  12 months

• Maximum proliferation area within stent segment

  12 months

• Minimal lumen area within stent segment

  12 months

Other Outcomes (10)

• Maximum lipid angle

  Baseline

• Calcium volume

  Baseline

• Macrophage volume

  Baseline

Study Arms (2)

OSA

Other: OSA

Non-OSA

Other: Non-OSA

Interventions

OSA OTHER

Patients with OSA (apnea hypopnea index ≥15) based on sleep study

OSA

Non-OSA OTHER

Patients without OSA (apnea hypopnea index \<15) based on sleep study

Non-OSA

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing PCI with stenting and 3-vessel OCT and receiving overnight sleep study (polygraphy)

You may qualify if:

• to 80 years old
• Patients undergoing PCI with stenting in at least one de novo lesion in a native coronary artery
• vessel OCT was available visually (at least one pullback/vessel)
• Written informed consent

You may not qualify if:

• Predominantly central sleep apnea (CSA, ≥50% central events or central apnea hypopnea index ≥10/h)
• Previous or current use of continuous positive airway pressure (CPAP)
• Cardiogenic shock (systolic arterial pressure \<90mmHg), congestive heart failure (NYHA or Killip≥3)
• STEMI within 1 week
• Prior PCI or CABG
• Chronic kidney disease \[eGFR\<60ml/(min\*1.73m2)\]
• Aortic-coronary ostial lesion
• Left main lesion
• Chronic total occlusion
• In-stent restenotic lesion
• A tortuous vessel and/or severely calcified lesion or severe stenosis and the OCT catheter could not pass across the lesion
• Massive residual thrombus on angiography despite thrombus aspiration or thrombectomy
• Planned elective PCI within 12 months
• Severe comorbidities: eg. malignancy (life expectancy \<2 years)
• Known or planned pregnancy

Sponsors & Collaborators

• Beijing Anzhen Hospital: lead

Study Sites (1)

Beijing Anzhen Hospital, Capital Medical University

Beijing, 100029, China

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease; Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Central Study Contacts

Shao-Ping Nie, MD, PhD

CONTACT

86-10-84005256; spnie@ccmu.edu.cn

Xiao Wang, MD

CONTACT

86-10-84005255; spaceeye123@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine, Director, Emergency & Critical Care Center

Study Record Dates

• First Submitted: July 1, 2019
• First Posted: July 17, 2019
• Study Start: April 18, 2018
• Primary Completion: November 12, 2019
• Study Completion: October 31, 2021
• Last Updated: September 5, 2021

Record last verified: 2021-09

Locations

CN (1)