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Forecasting IVUS-Identified High-Risk Coronary Plaques Utilizing a Deep Learning Model that Integrates Microvascular (Retinal) and Macrovascular (Angiographic) Imaging Characteristics

Forecasting IVUS-Identified High-Risk Coronary Plaques Utilizing a Deep Learning Model that Integrates Microvascular (Retinal) and Macrovascular (Angiographic) Imaging Characteristics

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600122097
Enrollment
Unknown
Registered
2026-04-09
Start date
2026-04-15
Completion date
Unknown
Last updated
2026-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary atherosclerotic heart disease

Interventions

Gold Standard:Definition of Vulnerable Plaque by IVUS: A plaque is defined as high-risk/vulnerable if it meets at least one of the following criteria: Plaque burden > 70%. Minimum lumen area (MLA) < 4
Index test:Using deep learning algorithms or automated machine recognition to extract features of the retinal microcirculation from fundus images and fundus OCAT scans

Sponsors

The 7th People's Hospital of Zhengzhou
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Age 18-80 years old, gender is not limited. 2. Selective coronary angiography (CAG) is planned due to clinical indications (e.g. stable angina, unstable angina, etc.). 3. CAG results show critical lesions (50%-70% lumen diameter stenosis) in at least one major coronary artery, and the clinician believes that IVUS is necessary or can be considered to guide therapeutic decisions. 4. The patient has a clear refractive interstitium and is able to cooperate in completing a high-quality fundus photography examination. 5. Patients understood the purpose and procedure of the study, participated voluntarily and signed a written informed consent form.

Exclusion criteria

Exclusion criteria: 1. Patients requiring urgent direct PCI such as acute ST-segment elevation myocardial infarction (STEMI). 2. Known history of severe allergy to contrast media or other contraindications to IVUS operation (e.g., severe renal insufficiency). 3. The target lesion is located in a severely tortuous, calcified vessel or in an in-stent restenotic lesion that is not expected to pass through the IVUS catheter. 4. Previous history of coronary artery bypass grafting (CABG). 5. Ocular disease that severely affects the morphology of the vasculature in the fundus, such as advanced glaucoma, retinal detachment, uveitis, and proliferative diabetic retinopathy. 6. Poor image quality in any modality (CAG, IVUS or fundus photographs) for subsequent quantitative analysis. 7. Pregnant or lactating women. 8. Other conditions that the investigator considers unsuitable for enrollment

Design outcomes

Primary

MeasureTime frame
AUC(Area Under the ROC Curve);

Secondary

MeasureTime frame
Sensitivity;Specificity;Positive predictive value, PPV;Negative predictive value, NPV;

Countries

China

Contacts

Public ContactLei Yin

The 7th People's Hospital of Zhengzhou

yinlei3008@163.com+86 136 0371 0217

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Apr 17, 2026