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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05524896
Acronym
HD-FFRct
Enrollment
302
Registered
2022-09-01
Start date
2017-01-01
Completion date
2022-07-13
Last updated
2022-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vascular Diseases

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.

Interventions

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

Sponsors

St. Francis Medical Center, New Jersey
CollaboratorOTHER
The Christ Hospital
CollaboratorOTHER
Medical University of South Carolina
CollaboratorOTHER
Mie University
CollaboratorOTHER
Elucid Bioimaging Inc.
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

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)

Design outcomes

Primary

MeasureTime frameDescription
Sensitivity1 daythe ability of a test to correctly identify patients with low FFR
Specificity1 daythe ability of a test to correctly identify people without low FFR

Secondary

MeasureTime frameDescription
Average Error1 dayDifference of noninvasive result - invasive result

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026