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NCT04220437
Identification of Neoatherosclerosis in ISR Patients Based on Artifical Intelligence
trial testing no interventin in In-stent Restenosis in 90 participants. Status unknown.
31 January 2021
Quick facts
| Lead sponsor | Chinese PLA General Hospital |
|---|---|
| Status | Status unknown |
| Study type | OBSERVATIONAL |
| Enrollment | 90 |
| Start date | 1 February 2015 |
| Primary completion | 31 January 2021 |
| Estimated completion | 28 February 2021 |
| Sites | 1 location across China |
Drugs / interventions tested
- no interventin
Conditions studied
- In-stent Restenosis — all drugs for In-stent Restenosis →
- Neo-atherosclerosis — all drugs for Neo-atherosclerosis →
- Retrospective — all drugs for Retrospective →
Sponsor
Chinese PLA General Hospital
Who can join
Adults 18 to 80, any sex, with In-stent Restenosis or Neo-atherosclerosis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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)
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04220437
- Europe PMC full search
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04220437 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Chinese PLA General Hospital
- Last refreshed: 15 January 2021
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