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出境医 / 临床实验 / Vascular Responses After Percutaneous Coronary Intervention With Stenting In Patients With Obstructive Sleep Apnea (VISION)

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

Study Description
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.

Condition or disease Intervention/treatment
Coronary Artery Disease Obstructive Sleep Apnea of Adult Other: OSA Other: Non-OSA

Study Design
Layout table for study information
Study Type : Observational
Estimated Enrollment : 84 participants
Observational Model: Cohort
Time Perspective: Prospective
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)
Actual Study Start Date : April 18, 2018
Estimated Primary Completion Date : August 31, 2020
Estimated Study Completion Date : October 31, 2020
Arms and Interventions
Group/Cohort Intervention/treatment
OSA Other: OSA
Patients with OSA (apnea hypopnea index ≥15) based on sleep study
Non-OSA Other: Non-OSA
Patients without OSA (apnea hypopnea index <15) based on sleep study
Outcome Measures
Primary Outcome Measures :
  1. Relative proliferation volume within stent segment (% of stent volume) [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Change of total lipid volume index in the non-culprit lesion [ Time Frame: 12 months ]
  2. Maximum area stenosis within stent segment [ Time Frame: 12 months ]
    Defined as minimal lumen area divided by the mean of reference lumen area

  3. Total proliferation volume within stent segment [ Time Frame: 12 months ]
  4. Maximum proliferation area within stent segment [ Time Frame: 12 months ]
  5. Minimal lumen area within stent segment [ Time Frame: 12 months ]
  6. Prevalence of uncovered struts, uncovered and apposed struts, malapposed struts [ Time Frame: 12 months ]
  7. Prevalence of neoatherosclerosis [ Time Frame: 12 months ]
  8. Total lipid volume index [ Time Frame: Baseline ]
    Defined as the averaged lipid angle multiplied by lipid length; including culprit and non-culprit lesions

  9. Prevalence of TCFA [ Time Frame: Baseline ]
    In the culprit and non-culprit lesions

  10. Prevalence of plaque rupture [ Time Frame: Baseline ]
    In the culprit and non-culprit lesions

  11. Rate of major adverse cardiac events (cardiac death, myocardial infarction, or ischemic-driven repeat revascularization) [ Time Frame: 12 months ]

Other Outcome Measures:
  1. Maximum lipid angle [ Time Frame: Baseline ]
  2. Calcium volume [ Time Frame: Baseline ]
  3. Macrophage volume [ Time Frame: Baseline ]
  4. Correlation of total lipid volume index with AHI [ Time Frame: Baseline ]
  5. Correlation of total lipid volume index with lowest SpO2 [ Time Frame: Baseline ]
  6. Correlation of total lipid volume index total time with SpO2 <90% [ Time Frame: Baseline ]
  7. Total lipid volume index stratified by sex in both groups [ Time Frame: Baseline ]
  8. Total lipid volume index stratified by obesity in both groups [ Time Frame: Baseline ]
  9. Total lipid volume index stratified by diabetes in both groups [ Time Frame: Baseline ]
  10. Rate of individual cardiovascular events [ Time Frame: 12 months ]
    Including all-cause death, cardiac death, myocardial infarction, target vessel revascularization, target lesion revascularization, non-target vessel revascularization, hospitalization for unstable angina


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients undergoing PCI with stenting and 3-vessel OCT and receiving overnight sleep study (polygraphy)
Criteria

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
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Shao-Ping Nie, MD, PhD 86-10-84005256 spnie@ccmu.edu.cn
Contact: Xiao Wang, MD 86-10-84005255 spaceeye123@126.com

Locations
Layout table for location information
China
Beijing Anzhen Hospital, Capital Medical University Recruiting
Beijing, China, 100029
Contact: Shao-Ping Nie, MD, PhD    86-10-84005256    spnie@ccmu.edu.cn   
Principal Investigator: Shao-Ping Nie, MD, PhD         
Sponsors and Collaborators
Beijing Anzhen Hospital
Tracking Information
First Submitted Date July 1, 2019
First Posted Date July 17, 2019
Last Update Posted Date July 17, 2019
Actual Study Start Date April 18, 2018
Estimated Primary Completion Date August 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 14, 2019) 		Relative proliferation volume within stent segment (% of stent volume) [ Time Frame: 12 months ]
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: July 14, 2019)
  • Change of total lipid volume index in the non-culprit lesion [ Time Frame: 12 months ]
  • Maximum area stenosis within stent segment [ Time Frame: 12 months ]
    Defined as minimal lumen area divided by the mean of reference lumen area
  • Total proliferation volume within stent segment [ Time Frame: 12 months ]
  • Maximum proliferation area within stent segment [ Time Frame: 12 months ]
  • Minimal lumen area within stent segment [ Time Frame: 12 months ]
  • Prevalence of uncovered struts, uncovered and apposed struts, malapposed struts [ Time Frame: 12 months ]
  • Prevalence of neoatherosclerosis [ Time Frame: 12 months ]
  • Total lipid volume index [ Time Frame: Baseline ]
    Defined as the averaged lipid angle multiplied by lipid length; including culprit and non-culprit lesions
  • Prevalence of TCFA [ Time Frame: Baseline ]
    In the culprit and non-culprit lesions
  • Prevalence of plaque rupture [ Time Frame: Baseline ]
    In the culprit and non-culprit lesions
  • Rate of major adverse cardiac events (cardiac death, myocardial infarction, or ischemic-driven repeat revascularization) [ Time Frame: 12 months ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures
 (submitted: July 14, 2019)
  • Maximum lipid angle [ Time Frame: Baseline ]
  • Calcium volume [ Time Frame: Baseline ]
  • Macrophage volume [ Time Frame: Baseline ]
  • Correlation of total lipid volume index with AHI [ Time Frame: Baseline ]
  • Correlation of total lipid volume index with lowest SpO2 [ Time Frame: Baseline ]
  • Correlation of total lipid volume index total time with SpO2 <90% [ Time Frame: Baseline ]
  • Total lipid volume index stratified by sex in both groups [ Time Frame: Baseline ]
  • Total lipid volume index stratified by obesity in both groups [ Time Frame: Baseline ]
  • Total lipid volume index stratified by diabetes in both groups [ Time Frame: Baseline ]
  • Rate of individual cardiovascular events [ Time Frame: 12 months ]
    Including all-cause death, cardiac death, myocardial infarction, target vessel revascularization, target lesion revascularization, non-target vessel revascularization, hospitalization for unstable angina
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title Vascular Responses After Percutaneous Coronary Intervention With Stenting In Patients With Obstructive Sleep Apnea
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)
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients undergoing PCI with stenting and 3-vessel OCT and receiving overnight sleep study (polygraphy)
Condition
  • Coronary Artery Disease
  • Obstructive Sleep Apnea of Adult
Intervention
  • 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
Study Groups/Cohorts
  • OSA
    Intervention: Other: OSA
  • Non-OSA
    Intervention: Other: Non-OSA
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: July 14, 2019) 		84
Original Estimated Enrollment Same as current
Estimated Study Completion Date October 31, 2020
Estimated Primary Completion Date August 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Shao-Ping Nie, MD, PhD 86-10-84005256 spnie@ccmu.edu.cn
Contact: Xiao Wang, MD 86-10-84005255 spaceeye123@126.com
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT04022824
Other Study ID Numbers 2017034
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Shao-Ping Nie, Beijing Anzhen Hospital
Study Sponsor Beijing Anzhen Hospital
Collaborators Not Provided
Investigators Not Provided
PRS Account Beijing Anzhen Hospital
Verification Date July 2019

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