The AIPLAQUE Study: An Artificial Intelligence-based Prospective Study to Analyze PLAQUE Using CCTA

This trial is a single-center, prospective, observational clinical study. All patients who have at least one coronary artery stenosis of 30%-90% in diameter ≥ 2mm confirmed by CCTA, and who are scheduled to undergo clinically indicated invasive coronary angiography (ICA) and optical coherence tomography (OCT) evaluation and/or treatment will be eligible for enrollment. We proposed a novel approach that integrates CCTA, ICA and OCT images to automatically measure plaque characterization and calculate CT-FFR using computational fluid dynamics (CFD) simulation and artificial intelligence deep learning.

Inclusion Criteria:Age ≥18 years and able to understand the purpose of the study and sign the informed consent;Patients who presented with stable angina pectoris or acute coronary syndrome;Patients who meet the indications for coronary CT angiography, percutaneous coronary angiography and intravascular imaging;Among those patients, patients who have at least one coronary artery stenosis of 30% - 90% in diameter ≥ 2mm confirmed by CCTA.Exclusion Criteria:Known pregnancy or breastfeeding at the time of enrollment;Hemodynamic instability;Allergy to contrast media or aspirin, adenosine etc.;History of stroke or transient ischemic attack (TIA) within 12 months before surgery;Known renal insufficiency (e.g. serum creatinine >2.0mg/dL, or creatinine clearance ≤30 mL/min), or need for dialysis, or acute kidney failure (as per physician judgment);Leukopenia (WBC<4.0*10*9/L), thrombocytopenia (PLT<100*10*9/L) or thrombocytopenia (PLT>300*10*9/L);Subjects who receiving oral or intravenous immunosuppressant therapy (other than inhaled steroids) or have an autoimmune disease (e.g., AIDS, SLE; except diabetes);Any other factors that researchers consider not suitable for inclusion or completion of this study.