Coronary Artery DiseaseVISIONNCT04022824
Vascular Responses After Percutaneous Coronary Intervention With Stenting In Patients With Obstructive Sleep Apnea
An observational study of Coronary Artery Disease and Obstructive Sleep Apnea of Adult, run by Beijing Anzhen Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Coronary Artery Disease, Obstructive Sleep Apnea of Adult
- What is being tested?
- OSA and Non-OSA
- How many people
- 84 participants
- Where
- 1 siteChina
- Study dates
- 18 Apr 2018to 31 Oct 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing PCI with stenting and 3-vessel OCT and receiving overnight sleep study (polygraphy)
Who may be able to join
- 18 to 80 years old
- Patients undergoing PCI with stenting in at least one de novo lesion in a native coronary artery
- 3-vessel OCT was available visually (at least one pullback/vessel)
- Written informed consent
Who cannot join
- 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)]
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- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Anzhen Hospital, Capital Medical University
Beijing, 100029
Shao-Ping Nie, MD, PhD, 86-10-84005256, spnie@ccmu.edu.cn
Shao-Ping Nie, MD, PhD
About this study
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)
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.
- Being tested
- OSA, Non-OSA
- Keywords
- Coronary artery disease, Obstructive sleep apnea, Optical coherence tomography, Vascular response
- Medical subject headings
- Coronary Artery Disease, Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OSAOther
Patients with OSA (apnea hypopnea index ≥15) based on sleep study
Non-OSAOther
Patients without OSA (apnea hypopnea index <15) based on sleep study
| Study group | Role | What they receive |
|---|---|---|
| OSA | Not described Receives: Other: OSA | |
| Non-OSA | Not described Receives: Other: Non-OSA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative proliferation volume within stent segment (% of stent volume)
Measured: 12 months
Secondary outcomes (11)
Change of total lipid volume index in the non-culprit lesion
Measured: 12 months
Maximum area stenosis within stent segment
Defined as minimal lumen area divided by the mean of reference lumen area
Measured: 12 months
Total proliferation volume within stent segment
Measured: 12 months
Maximum proliferation area within stent segment
Measured: 12 months
Minimal lumen area within stent segment
Measured: 12 months
Prevalence of uncovered struts, uncovered and apposed struts, malapposed struts
Measured: 12 months
Prevalence of neoatherosclerosis
Measured: 12 months
Total lipid volume index
Defined as the averaged lipid angle multiplied by lipid length; including culprit and non-culprit lesions
Measured: Baseline
Prevalence of TCFA
In the culprit and non-culprit lesions
Measured: Baseline
Prevalence of plaque rupture
In the culprit and non-culprit lesions
Measured: Baseline
Rate of major adverse cardiac events (cardiac death, myocardial infarction, or ischemic-driven repeat revascularization)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2019
- Study start18 Apr 2018
- Primary completion12 Nov 2019
- Study completion31 Oct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Beijing Anzhen HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Anzhen Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shao-Ping Nie, Beijing Anzhen Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04022824
- Sponsor's protocol ID
- 2017034
- Acronym
- VISION
- Status last verified
- Sep 2021
- First submitted
- 1 Jul 2019
- Last updated
- 5 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04022824
- Acronym / sponsor ID
- VISION / 2017034
- Keywords
- Coronary artery disease, Obstructive sleep apnea, Optical coherence tomography, Vascular response
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Beijing Anzhen HospitalUniversity, hospital or other
- Study start
- 18 Apr 2018 (actual)
- Primary completion
- 12 Nov 2019 (actual)
- Study completion
- 31 Oct 2021 (estimated)
- First posted
- 17 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OSA | – | Other: OSA |
| Non-OSA | – | Other: Non-OSA |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing PCI with stenting and 3-vessel OCT and receiving overnight sleep study (polygraphy)
Key inclusion criteria (4 listed)
- 18 to 80 years old
- Patients undergoing PCI with stenting in at least one de novo lesion in a native coronary artery
- 3-vessel OCT was available visually (at least one pullback/vessel)
- Written informed consent
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OSAPatients with OSA (apnea hypopnea index ≥15) based on sleep study | Other | OSA |
| Non-OSAPatients without OSA (apnea hypopnea index <15) based on sleep study | Other | Non-OSA |
Primary outcome
Relative proliferation volume within stent segment (% of stent volume)
Time frame: 12 months
11 secondary outcomes
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
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
Prevalence of TCFA
Time frame: Baseline
Prevalence of plaque rupture
Time frame: Baseline
Rate of major adverse cardiac events (cardiac death, myocardial infarction, or ischemic-driven repeat revascularization)
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease and Obstructive Sleep Apnea of Adult, run by Beijing Anzhen Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shao-Ping Nie, MD, PhD (86-10-84005256, spnie@ccmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relative proliferation volume within stent segment (% of stent volume) (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2021.