Quantitative Analysis of Functional CT Imaging of Coronary Atherosclerosis

Study Overview
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Brief Summary
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The purpose of this prospective observational study is to evaluate the diagnostic and prognostic performance of a one-stop comprehensive coronary artery anatomy and function assessment for CAD.

Detailed Description
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Coronary CT angiography (CCTA) has become a reliable diagnostic technique to evaluate coronary artery disease (CAD) with high sensitivity and a negative predictive value. However, CCTA provides only anatomic information and tends to overestimate stenosis severity and is limited in its ability to diagnose myocardial ischemia. Undertaking additional CT myocardial perfusion imaging(CT-MPI) and CT-FFR improves specificity and positive predictive value, reducing unnecessary invasive coronary angiography. The purpose of this prospective observational study is to evaluate the diagnostic and prognostic performance of a one-stop comprehensive coronary artery anatomy and function assessment for CAD. SPECT myocardial perfusion imaging (SPECT-MPI)and invasively measured fractional flow reserve (FFR) will serve as the reference standard.

Official Title
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Quantitative Analysis of Functional Computed Tomography (CT) Imaging of Coronary Atherosclerosis

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Diagnostic Test: CCTA, CT-MPI, CT-FFR, SPECT-MPI


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years Understand the purpose of the trial, voluntarily participate in this study, and have signed an informed consent form. Patients with known or suspected CAD Exclusion Criteria: Patients with acute coronary syndrome. Severe cardiac dysfunction (LVEF ≤ 0.3). Cardiomyopathy with non-coronary causes such as hypertrophic cardiomyopathy, dilated cardiomyopathy, alcoholic cardiomyopathy, and myocardial amyloidosis. Severe cardiac valve disease with more than moderate valvular regurgitation and/or valvular stenosis. Severe hepatic and renal dysfunction (ALT ≥ 3 Upper Limit of Normal, Cr> 134μ/mol/L (2mg/dl) or estimated Glomerular Filtration Rate<45ml/min/1.73m2). Severe arrhythmias (persistent atrial fibrillation, second-degree or third-degree atrioventricular block, etc.) Malignancy or other pathophysiological conditions with an expected survival of less than 1 year Allergic to the drug components involved in this study and those who are intolerant to loading tests Pregnant or lactating women. Mental disorders. Failure to sign the informed consent form. Other conditions that are incompatible with the clinical study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Myocardial Perfusion examination<br> | Diagnostic Test: CCTA, CT-MPI, CT-FFR, SPECT-MPI<br>* Subjects undergo CCTA, CT-MPI, CT-FFR or SPECT-MPI<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major Adverse Cardiovascular Events | including cardiac death, all-cause death, acute coronary syndrome, readmission for acute coronary syndrome or heart failure, and Revascularization. | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic performance of CT-MPI | Diagnostic accuracy, Sensitivity, specificity, negative predictive value(NPV) and positive predictive value(PPV) of CT-perfusion imaging (quantitative and qualitative analysis) to determine the presence/absence of significant coronary artery disease at the subject level when compared with invasive FFR and SPECT-MPI. | From admission to discharge, up to 1 week | 
| Diagnostic performance of CT-FFR | Diagnostic accuracy, Sensitivity, specificity, negative predictive value(NPV) and positive predictive value(PPV) of CT-FFR to determine the presence/absence of significant coronary artery disease at the subject level when compared with invasive FFR and SPECT-MPI. | From admission to discharge, up to 1 week | 
| Diagnostic performance of CT-MPI | Diagnostic accuracy, Sensitivity, specificity, negative predictive value(NPV) and positive predictive value(PPV) of CT-perfusion imaging (quantitative and qualitative analysis) to determine the presence/absence of significant coronary artery disease in per-vessel level when compared with invasive FFR and SPECT-MPI. | From admission to discharge, up to 1 week | 
| Diagnostic performance of CT-FFR | Diagnostic accuracy, Sensitivity, specificity, negative predictive value(NPV) and positive predictive value(PPV) of CT-FFR to determine the presence/absence of significant coronary artery disease in per-vessel level when compared with invasive FFR and SPECT-MPI. | From admission to discharge, up to 1 week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CT myocardial perfusion imaging, SPECT myocardial perfusion imaging