In-stent RestenosisNCT04220437
Identification of Neoatherosclerosis in ISR Patients Based on Artifical Intelligence
An observational study of In-stent Restenosis and Neo-atherosclerosis, run by Chinese PLA General Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- In-stent Restenosis, Neo-atherosclerosis, Retrospective
- What is being tested?
- no interventin
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2015to 28 Feb 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: 100 patients were enrolled
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The General Hospital of PLA
Beijing, 100853
Yundai Chen, MD, +8613311119778, cyundai@vip.163.com
About this study
Official title: Identification of Neoatherosclerosis in In-stent Restenosis Patients Based on Artifical Intelligence
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)
- Conditions
- In-stent Restenosis, Neo-atherosclerosis, Retrospective
- Being tested
- no interventin
- Keywords
- Neoatherosclerosis, in-stent restenosis, Optical Coherence Tomography, angiography, artificial intelligence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventinOther
Our stusy analysed the images obtained from ISR patients, no extra intervention was given based on this study.
| Study group | Role | What they receive |
|---|---|---|
| CAG and OCT group | Images of CAG and OCT patients obtained from ISR patients were retrospectively collected and analyzed. Receives: Other: no interventin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: through the study completion, an average of 3 years
neovascularizaion
diameter 50-300um, cavity in the stent area, not connected with the vasular
Measured: through the study completion, an average of 3 years
ISR segment in the CAG images
the segement in the stent area or within 5mm beside the stent,diameter stenosis rate>50%
Measured: through the study completion, an average of 3 years
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.
Measured: through the study completion, an average of 3 years
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
Measured: through the study completion, an average of 3 years
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.
Measured: through the study completion, an average of 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2020
- Study start1 Feb 2015
- Primary completion31 Jan 2021 (estimated)
- Study completion28 Feb 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for In-stent RestenosisStudies of the same condition, open and under way.
- More trials run by Chinese PLA General 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yun Dai Chen, Chinese PLA General Hospital
- Investigators
- Yundai Chen, M.D, Principal investigator, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04220437
- Sponsor's protocol ID
- AI-301-ISR
- Status last verified
- Jan 2021
- First submitted
- 21 Dec 2019
- Last updated
- 15 Jan 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Neoatherosclerosis in In-stent Restenosis Patients Based on Artifical Intelligence
- ClinicalTrials.gov ID
- NCT04220437
- Acronym / sponsor ID
- AI-301-ISR
- Conditions
- In-stent Restenosis, Neo-atherosclerosis, Retrospective
- Keywords
- Neoatherosclerosis, in-stent restenosis, Optical Coherence Tomography, angiography, artificial intelligence
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- 1 Feb 2015 (actual)
- Primary completion
- 31 Jan 2021 (estimated)
- Study completion
- 28 Feb 2021 (estimated)
- First posted
- 7 Jan 2020 (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.
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)
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)
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CAG and OCT group | – | Other: no interventinImages of CAG and OCT patients obtained from ISR patients were retrospectively collected and analyzed. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 100 patients were enrolled
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
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 |
|---|---|---|
| no interventinOur stusy analysed the images obtained from ISR patients, no extra intervention was given based on this study. | Other | CAG and OCT group |
Primary outcome
The identification of NA
Time frame: through the study completion, an average of 3 years
a neointima containing a diffuse border and a signal-poor region, with the struts underneath invisible because of the marked signal attenuation
neovascularizaion
Time frame: through the study completion, an average of 3 years
diameter 50-300um, cavity in the stent area, not connected with the vasular
ISR segment in the CAG images
Time frame: through the study completion, an average of 3 years
the segement in the stent area or within 5mm beside the stent,diameter stenosis rate>50%
lipid-core arc
Time frame: through the study completion, an average of 3 years
To quantify the circumferential extent of NA, the lipid-core arc was measured at a 0.2-mm interval throughout the segments showing NA.
Thin-cap fibroatheroma-like neointima
Time frame: through the study completion, an average of 3 years
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
macrophage arc
Time frame: through the study completion, an average of 3 years
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2021.
- Individual participant dataSharing planned: No
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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.
Yundai Chen, M.D principal investigator
Chinese PLA General Hospital
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 In-stent Restenosis and Neo-atherosclerosis, run by Chinese PLA General 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 3 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 15 Jan 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 Yingqian Zhang, M.D (15652505966 ext. 15652505966, niniya731@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The identification of NA (time frame: through the study completion, an average of 3 years). The study lists 6 primary outcomes in all. 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 15 Jan 2021.