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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

302 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-01-01

Study Completion Date

2022-07-13

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Vascular Diseases

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Low FFR

Invasive FFR value \<= 0.8

ElucidVivo

Intervention Type DEVICE

Plaque morphology characterization for predicting non-invasive fractional flow reserve (FFR)

High FFR

Invasive FFR value \> 0.8

ElucidVivo

Intervention Type DEVICE

Plaque morphology characterization for predicting non-invasive fractional flow reserve (FFR)

Interventions

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ElucidVivo

Plaque morphology characterization for predicting non-invasive fractional flow reserve (FFR)

Intervention Type DEVICE

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No