Elucidate Vasodilatory Capacity From Histology-Defined Analysis of Coronary CT Angiography

Completed

• Conditions: Vascular Diseases
• Interventions: Device: ElucidVivo

• Registration Number: NCT05524896
• Lead Sponsor: Elucid Bioimaging Inc.

Brief Summary

Coronary CT Angiography (CCTA) may be an ideal modality to fill gaps in understanding the extent and rate of progression coronary artery disease. The investigators have developed an image analysis software ElucidVivo that estimates relevant indices, including fractional flow reserve (FFR) . In this study, the investigators aim to assess the value of ElucidVivo-based plaque morphology characterization for predicting non-invasive FFR in patients with suspected coronary artery disease (CAD) who had undergone clinically indicated coronary CTA and invasive coronary angiography (ICA) for physical FFR measurement.

Detailed Description

Invasive FFR is a clinically validated measure of lesion-specific ischemia and is preferred over visual estimation of diameter stenosis for clinical decisions regarding coronary revascularization. FFR derived from coronary CTA (FFRct) using computational fluid dynamics (CFD)-based software has been shown to be a reasonably accurate estimate of invasive FFR and is included in contemporary guidelines as a decision-tool for management of patients with intermediate stenosis on coronary CTA. However, other methods have limitations. It is understood that the burden and type of coronary atherosclerosis, in addition to lumen stenosis, significantly impacts the vasodilatory capacity of the vessel walls which may provide a more interpretable analysis and broader clinical acceptance.

Study Timeline

• Study Start: 2017-01-01
• Primary Completion: 2021-05-31
• Study Completion: 2022-07-13
• Study First Submitted: 2022-08-30
• Study First Submitted QC: 2022-08-30
• Status Verified: 2022-09
• Study First Posted: 2022-09-01
• Last Update Submitted: 2022-09-05
• Last Update Posted: 2022-09-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 302

Inclusion Criteria

• Subject must have successfully completed at least one (possibly multiple) CCTA for known or suspected coronary artery disease.
• CCTA was no more than 60 days earlier (and not later)

Exclusion Criteria

• Subject has a history of percutaneous coronary intervention (PCI) with stent implantation and/or coronary artery bypass grafting (CABG)
• Subject with insufficient CCTA image quality (defined strictly as documented in the ElucidVivo Reading Manual)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Low FFR	ElucidVivo	Invasive FFR value \<= 0.8
High FFR	ElucidVivo	Invasive FFR value \> 0.8

Primary Outcome Measures

Name	Time	Method
Sensitivity	1 day	the ability of a test to correctly identify patients with low FFR
Specificity	1 day	the ability of a test to correctly identify people without low FFR

Secondary Outcome Measures

Name	Time	Method
Average Error	1 day	Difference of noninvasive result - invasive result