Validation of an Intracycle CT Motion CORrection Algorithm for Diagnostic AccuracY

Study Overview
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Brief Summary
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To demonstrate the incremental utility of SSF for individuals undergoing CCTA, with expected improvements in image quality and diagnostic accuracy.

Detailed Description
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Hypothesis: Coronary CT angiography (CCTA) employing a novel intracycle motion compensation algorithm (SnapShot Freeze [SSF]) will be superior to CCTA without an intracycle motion compensation algorithm (conventional CCTA) for diagnostic accuracy and image quality. Scientific Basis: Preliminary study (Leipsic, Min, Journal of Cardiovascular Computed Tomography [in press]) of coronary CT angiograms in individuals undergoing pre-procedural assessment for transcatheter aortic valve replacement (n=36) demonstrate improved image quality of CCTA using SSF compared to CCTA not using SSF. Importantly, individuals in this study did not receive heart rate slowing agents (e.g., beta blockers), and diagnostic image quality was substantially improved. While not statistically powered on a per-patient basis, per-segment diagnostic accuracy of CCTA using SSF was superior to conventional CCTA. These results are complementary to those derived from internal testing at GE Healthcare wherein phantom work has demonstrated improved diagnostic performance using SSF compared to conventional image acquisitions. Long-term Goal/Purpose: To demonstrate the incremental utility of SSF for individuals undergoing CCTA, with expected improvements in image quality and diagnostic accuracy. If the aims of this study are achieved, the use of SSF for effective temporal resolution improvement may obviate (or reduce) the need for CT hardware for improved temporal resolution.

Official Title
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Validation of an Intracycle CT Motion CORrection Algorithm for Diagnostic AccuracY: A Prospective Multicenter Study

Conditions
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Coronary Artery Disease, Coronary Arteriosclerosis

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Consenting adult patients ≥18 years of age; Suspected but without known prior history of CAD Not actively taking heart rate lowering agents at least 48 hours prior to study (e.g., AV nodal blockers such as beta blockers, calcium channel blockers or digoxin) Glomerular filtration rate >60 ml/min CCTA and ICA within 1 week of each other with no interscan event (e.g., myocardial infarction or coronary revascularization) Exclusion Criteria: Incomplete ICA or CCTA; Known CAD (prior myocardial infarction, PCI, CABG) Atrial Fibrillation Abnormal Renal Function (GFR <60 ml/min) Unwilling or unable to give consent Non-cardiac illness with life expectancy <1 year Concomitant participation in another clinical trial in which subject is subject to investigational drug or device Pregnant women Allergy to iodinated contrast agent Contraindications to nitroglycerin Systolic blood pressure ≤90 mm Hg Contraindications to β blockers or nitroglycerin

Ages Eligible for Study
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Minimum Age: 18 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 |
| --- | --- |
| CCTA Patient<br>Consenting adult patients ≥18 years of age; Suspected but without known prior history of CAD Not actively taking heart rate lowering agents at least 48 hours prior to study (e.g., AV nodal blockers such as beta blockers, calcium channel blockers or digoxin) Glomerular filtration rate >60 ml/min CCTA and ICA within 1 week of each other with no interscan event (e.g., myocardial infarction or coronary revascularization) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic Accuracy | To compare the per-patient, per-vessel and per-segment diagnostic accuracy of CCTA with SSF to conventional CCTA, as compared to invasive quantitative coronary angiography. | 30 days | 
| Diagnostic Interpretability | To compare the per-patient, per-vessel and per-segment diagnostic interpretability of CCTA with SSF to conventional CCTA, as compared to invasive quantitative coronary angiography. | 30 days | 
| Image quality | To compare the per-patient, per-vessel and per-segment quantitative image quality of CCTA with SSF to conventional CCTA, as compared to invasive quantitative coronary angiography. | 30 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Upper threshold of heart rate | To determine the upper threshold of heart rate below which CCTA with SSF is most effective. | 1 day | 
| incremental & additive value | To determine the incremental & additive value of SSF to conventional CCTA for diagnostic accuracy / diagnostic interpretability / image quality. | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Heart Disease, Coronary Artery Disease, Coronary Arteriosclerosis