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Detection of INFLAMed and vulnerable coronary plaque using artificial intelligence Modality in Computed Tomography angiography

Detecting coronary plaque-specific inflammation using an artificial-intelligence aided computed tomography software

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400093460
Enrollment
Unknown
Registered
2024-12-05
Start date
2025-01-01
Completion date
Unknown
Last updated
2024-12-09

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:Gold standard of plaque active inflammation based on PET-CT: 18F-NaF TBRmax > 1.30
Gold standard of anatomic high-risk plaque met at least two of the following criteria based on OCT: fibrous hat thickness 180°, or detection of macrophages.
Index test:Plaque active inflammation based on CCTA-AI software (Shanghai United Imaging Healthcare Co., Ltd): plaque specific fat attenuation index (pFAI)
Anatomic high-risk plaque met at least two of the following criteria based on CCTA-AI software (Shanghai United Imaging Healthcare Co., Ltd): positive remodeling, low-attenuation plaque, napkin-ring s

Sponsors

Beijing Anzhen Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Age > 18; 2.Signed informed consent form; 3.Participants who diagnosed with stable angina, unstable angina or myocardial infarction (1~8 weeks from symptom onset), undergoing invasive coroanry angiography and optical coherence tomography; 4.Non-culprit plaque with diameter stenosis 25%~75% within a coronary artery = 2.0mm in diameter based on coronary angiography.

Exclusion criteria

Exclusion criteria: 1.Myocardial infarction within 1 week from symptom onset, cardiogenic shock; 2.Prior myocardial revascularization; 3.Contraindication to CTA, PET-CT, invasive coronary angiography or OCT, or poor image quality; 4.Abnormal liver function or renal function; 5.Echocardiography LVEF < 30%; 6.Uncontrolled infectious disease; 7.Autoimmune disease; 8.Prior or planned treatment with anti-inflammatroy medications; 9.Left main stenosis = 50%; 10.Pregnant or lactating women, or women of childbearing age; 11.Participant of other clinical trials within past 3 months; 12.Life expectancy < 1 year.

Design outcomes

Primary

MeasureTime frame
Plaque specific fat attenuation index (pFAI);Anatomic high-risk plaque based on CCTA;—

Countries

China

Contacts

Public ContactYu Du

Department of Cardiology, Beijing Anzhen Hospital, Capital Medical University

18518389843@163.com+86 185 1838 9843

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026