Dynamic CT Perfusion for Functional Assessment of Coronary Artery Disease

Study Overview
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Brief Summary
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The objective of this multicenter study is to evaluate the diagnostic accuracy of dynamic cardiac CT perfusion (CTP) imaging for non-invasive functional assessment of coronary artery disease (CAD). The proposed CTP technique allows concomitant assessment of two imaging-derived cardiac biomarkers including fractional flow reserve (FFR) and myocardial perfusion from a single dynamic imaging sequence, which facilities simultaneous evaluation of the hemodynamics in epicardial coronary arteries and coronary microcirculation in patients with CAD. The CTP results will be compared with invasive coronary angiography / FFR assessment and non-invasive cardiac magnetic resonance imaging (CMR) / radionuclide perfusion assessment.

Official Title
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Multicenter Diagnostic Performance of Dynamic CT Perfusion for Functional Assessment of Coronary Artery Disease

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Diagnostic Test: Dynamic cardiac CT perfusion imaging


Participation Criteria
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Eligibility Criteria
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Subject Inclusion Criteria Patients need to meet all the following inclusion criteria to be enrolled in the study: Symptomatic and hemodynamically stable Acute coronary syndrome (ACS) ruled out based on absence of abnormal changes in ECG and cardiac enzymes Referral for cardiac catheterization based on clinical history and non-invasive imaging test findings. Non-invasive imaging findings include one or more of the following: (i) Evidence of myocardial ischemia from radionuclide myocardial perfusion imaging; (ii) Evidence of myocardial ischemia from CMR myocardial perfusion imaging; (iii) Evidence of ≥ 50% stenosis in the left circumflex artery (LCx), left anterior descending artery (LAD) and/or right coronary artery (RCA) from CCTA. Ability to undergo stress myocardial perfusion test (absence of contraindications for vasodilator) Written informed consent Subject Exclusion Criteria Patients meeting at least one of the following criteria will be excluded from the study: Recent (< 1 month) ACS CCTA reveals ≥ 50% stenosis in the left main artery Severe chronic kidney disease (CKD) with estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73m2 Contraindications to stress perfusion imaging, including: i) severe reactive airway disease; ii) high-grade atrioventricular block; iii) allergy to vasodilators; iv) caffeine within 12 hours; v) theophylline use within 48 hours. History of CABG surgery History of malignancy during the past 3 years prior to screening History of alcohol and/or drug abuse within 3 years prior to screening Sign of pregnancy Pregnant or nursing History of severe allergic or anaphylactic reaction to any allergen including drugs and contrast agents Recent (< 1 month) use of an investigational drug or device Participation in any other investigational drug or device trial during the conduct of this study Lack of ability or willingness to comply with the protocol requirements or deemed by the Site Investigator to be unfit for the study

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with coronary artery disease and hemodynamically stable<br> | Diagnostic Test: Dynamic cardiac CT perfusion imaging<br>* Multiple images of the heart are acquired with a clinical CT scanner after an intravenous bolus injection of contrast solution. The images are then analyzed to provide fractional flow reserve and myocardial perfusion values.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy of myocardial perfusion obtained from dynamic cardiac CT perfusion imaging for detecting functionally significant coronary artery stenosis | Comparison with invasive coronary angiography and FFR assessment | Within 4 weeks prior to invasive cardiac catheterization | 
| Accuracy of FFR obtained from dynamic cardiac CT perfusion imaging for detecting functionally significant coronary artery stenosis | Comparison with invasive coronary angiography and FFR assessment | Within 4 weeks prior to invasive cardiac catheterization | 
| Accuracy of combined myocardial perfusion and FFR measurement obtained from dynamic cardiac CT perfusion imaging for detecting functionally significant coronary artery stenosis | Comparison with invasive coronary angiography and FFR assessment | Within 4 weeks prior to invasive cardiac catheterization | 
| Comparison of diagnostic accuracy for functional CAD assessment between dynamic CT perfusion and static CT perfusion | Comparison in patients with multi-vessel CAD where balanced ischemia is expected | Within 4 weeks prior to invasive cardiac catheterization | 
| Comparison of diagnostic accuracy for functional CAD assessment between dynamic CT perfusion and CT-FFR (based on computational fluid dynamics simulation) | Comparison in patients with dense coronary calcification | Within 4 weeks prior to invasive cardiac catheterization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of diagnostic accuracy for functional CAD assessment between dynamic CT perfusion and other non-CT perfusion imaging techniques | Comparison with CMR / radionuclide perfusion assessment | Within 4 weeks of the acquisition of non-CT perfusion imaging | 
| Comparison of diagnostic accuracy of dynamic CT perfusion for functional CAD assessment between male and female patients | Sex-based analysis | Within 4 weeks prior to invasive cardiac catheterization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Computed Tomography, Myocardial Perfusion, Fractional Flow Reserve