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Status unknownNCT04220437Updated Jan 15, 2021

Identification of Neoatherosclerosis in ISR Patients Based on Artifical Intelligence

An observational study in In-stent Restenosis, Neo-atherosclerosis and Retrospective, sponsored by Chinese PLA General Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2021-01-15.

Sponsored by Chinese PLA General Hospital · Observational

The sponsor has not verified this record recently (last verified Jan 2021), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Other
Time perspective
Retrospective
Enrollment
90
Ages
18 Years to 80 Years
Sex
All
01

Study summary

Based on the large population of patients, in-stent restenosis (ISR) is still an important problem in the field of cardiovascular disease. How to reduce the incidence of ISR and the treatment of ISR has become the focus and hot spot. The 2018 ESC Guidelines for Cardiovascular Intervention recommends treatment of ISR under the guidance of intravascular ultrasound (IVUS), or optical coherent tomography (OCT). Circulation published a new Waksman ISR classification based on mechanisms and components of the restenosis tissue, which provides guidance for treatment strategy. Because of its good resolution, OCT makes it more accurate to distinguish the components of vascular tissue, thus providing a decision-making basis for interventional therapy. OCT examination can obtain the characteristics of the ISR more precisely. Neoatherosclerosis (NA), is one of the ISR types and accounts for more stent failure and target lesion failure than other types. Identification NA is important for decision-making of interventional therapy. However, the acquisition and analysis of OCT images not only need the digital angiography machine (DSA) equipped with the majority of hospitals, but also need professional OCT imaging equipment and technicians. Patients with severely CKD cannot bear OCT examination because of the large amount of contrast agent. OCT catheter is more than ten times the price of the CAG catheter. Therefore, identification of NA by the use of artificial intelligence (AI) is of significance to set therapeutic strategy for ISR patients, especially in patients with CKD. Our study retrospectively analyzed CAG images and OCT images of ISR patients obtained from Jan 1st,2015 to Oct 31st,2020. Identify NA by analyzing OCT images, build up U-net and V-net to analyze the CAG and OCT images, and finally build up an identification system of NA based on CAG images by AI. This study has been approved by Ethics Committee of Chinese PLA General Hospital (S2018-033-01)

Read the detailed description

Drug Eluting Stents (DES) reduce the rate of in-stent restenosis (ISR) to 3.6-10%. Based on the large population of patients, ISR is still an important problem in the field of cardiovascular disease. How to reduce the incidence of ISR and the treatment of ISR has become the focus and hot spot. The 2018 ESC Guidelines for Cardiovascular Intervention recommends treatment of ISR under the guidance of intravascular ultrasound (IVUS), or optical coherent tomography (OCT). The European Expert Consensus on Intravascular Imaging, published in 2018, recommends finding the underlying mechanisms of ISR through intravascular imaging guidance (IVUS or OCT), and determining therapeutic strategies based on the mechanisms. Circulation published a new Waksman ISR classification based on mechanisms and components of the restenosis tissue, which provides guidance of treatment strategy. The use of intravascular imaging to identify and classify the types and mechanisms is very important for ISR treatment strategy. Because of its good resolution, OCT makes it more accurate to distinguish the components of vascular tissue, thus providing a decision-making basis for interventional therapy. OCT examination can obtain the characteristics of ISR more precisely. Neoatherosclerosis (NA), is one of the ISR types and accounts for more stent failure and target lesion failure than other types. Identification of NA is important for decision-making of interventional therapy. However, the acquisition and analysis of OCT images not only need the digital angiography machine (DSA) equipped with the majority of hospitals, but also need professional OCT imaging equipment and technicians. Patients with severely CKD cannot bear OCT examination because of the large amount of contrast agent. OCT catheter is more than ten times the price of the CAG catheter. Therefore, identification of NA by the use of artificial intelligence (AI) is of significance to set therapeutic strategy for ISR patients, especially in patients with CKD. Our study retrospectively analyzed CAG images and OCT images of ISR patients obtained from Jan 1st,2015 to Jan 31st,2020. Offline OCT analysis was performed using dedicated software (Light Lab Imaging Inc, Westford, MA). All images were analyzed at every frame in the stents by 2 independent investigators, who were blinded to the angiographic and clinical findings. Identify NA by analyzing OCT images, build up U-net and V-net to analyze the CAG and OCT images, and finally build up an identification system of NA based on CAG images by AI. This study has been approved by Ethics Committee of Chinese PLA General Hospital (S2018-033-01)

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Conditions studied

  • In-stent Restenosis
  • Neo-atherosclerosis
  • Retrospective

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Keywords

  • Neoatherosclerosis
  • in-stent restenosis
  • Optical Coherence Tomography
  • angiography
  • artificial intelligence
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In context

Atherosclerosis

1,567 studies on the registry are indexed under Atherosclerosis; 264 are open to participants now.

This study's planned enrollment of 90 is below the median of 223 across 571 observational studies indexed under Atherosclerosis.

Browse Atherosclerosis studies →

Lead sponsor

Chinese PLA General Hospital is the lead sponsor of 558 studies on the registry; 202 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

100 patients were enrolled

Inclusion criteria

  • all gender

18ys old to 80ys old

diagnosed of in-stent restenosis based on CAG

both CAG images and OCT images were obtained in the same patient on the same day

Exclusion criteria

Exclusion Criteria:

  • CAG images and OCT images were not obtained on the same day in the same patient

low quality in CAG images

low qualitiy in OCT images

05

Study design

Observational model
Other
Time perspective
Retrospective
Enrollment
90 participants (estimated)
Patient registry
No

Groups and cohorts

  • CAG and OCT group

    Images of CAG and OCT patients obtained from ISR patients were retrospectively collected and analyzed.

    Other: no interventin

Interventions

  • Otherno interventin

    Our stusy analysed the images obtained from ISR patients, no extra intervention was given based on this study.

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What researchers measure

Primary outcomes

  1. The identification of NA

    a neointima containing a diffuse border and a signal-poor region, with the struts underneath invisible because of the marked signal attenuation

    Time frame: through the study completion, an average of 3 years

  2. neovascularizaion

    diameter 50-300um, cavity in the stent area, not connected with the vasular

    Time frame: through the study completion, an average of 3 years

  3. ISR segment in the CAG images

    the segement in the stent area or within 5mm beside the stent,diameter stenosis rate\>50%

    Time frame: through the study completion, an average of 3 years

  4. lipid-core arc

    To quantify the circumferential extent of NA, the lipid-core arc was measured at a 0.2-mm interval throughout the segments showing NA.

    Time frame: through the study completion, an average of 3 years

  5. Thin-cap fibroatheroma-like neointima

    defined as a neointima characterized by a fibrous cap thickness at the thinnest part of \<65 μm and an angle of lipid-laden neointima of \>180 degrees

    Time frame: through the study completion, an average of 3 years

  6. macrophage arc

    measured at 0.2-mm intervals and divided into 5 groups: grade 0, no macrophages; grade 1, localized macrophage accumulation, \<30 degrees; grade 2, clustered accumulation, ≥30 and \<90 degrees; grade 3, clustered accumulation, ≥90 and \<270 degrees; and grade 4, clustered accumulation, ≥270 degrees.

    Time frame: through the study completion, an average of 3 years

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Study locations

1 of 1 sites recruiting
  • The General Hospital of PLA
    Beijing, 100853, China
    Recruiting
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 15, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04220437
Lead sponsor
Chinese PLA General Hospital
Responsible party
Yun Dai Chen (Professor, Chinese PLA General Hospital) — Principal investigator
First posted
Jan 7, 2020
Start date
Feb 1, 2015
Primary completion
Jan 31, 2021 (estimated)
Completion
Feb 28, 2021 (estimated)
Last update
Jan 15, 2021

Study contacts

Yingqian Zhang, M.D
Contact
niniya731@163.com
15652505966 ext. 15652505966
Hui Hui, PH.D
Contact
hui.hui@is.ac.cn
010-55499309 ext. 010-55499309
Yundai Chen, M.D
principal investigator · Chinese PLA General Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.

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