Clinical trial NCT05524896: Elucidate Vasodilatory Capacity From Histology-Defined Analysis of Coronary CT Angiography
Official title: Elucidate Vasodilatory Capacity From Histology-Defined Analysis of Coronary CT Angiography
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vascular Diseases
Lead sponsor: Elucid Bioimaging Inc.
Sponsor class: INDUSTRY
Collaborators: name: St. Francis Medical Center, New Jersey
name: The Christ Hospital
name: Medical University of South Carolina
name: Mie University
First posted: 2022-09-01
Enrollment: 302
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects for which a CCTA had been taken within 60 days of invasive coronary angiography with FFR measurements.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Sensitivity
timeFrame: 1 day
measure: Specificity
timeFrame: 1 day
Secondary outcomes:
measure: Average Error
timeFrame: 1 day
Other outcomes:
Locations:
Study officials:
affiliation: Elucid Bioimaging Inc.
name: Andrew J Buckler
role: PRINCIPAL_INVESTIGATOR
References:
citation: Varga-Szemes A, Schoepf UJ, Maurovich-Horvat P, Wang R, Xu L, Dargis DM, Emrich T, Buckler AJ. Coronary plaque assessment of Vasodilative capacity by CT angiography effectively estimates fractional flow reserve. Int J Cardiol. 2021 May 15;331:307-315. doi: 10.1016/j.ijcard.2021.01.040. Epub 2021 Jan 30.