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

Vascular Diseases Clinical Trial

— HD-FFRct  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05524896
• Other study ID #: HD-FFRct
• Status: Completed
• Start date: January 1, 2017
• Est. completion date: July 13, 2022

Study information

• Verified date: September 2022
• Source: Elucid Bioimaging Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 302
• Est. completion date: July 13, 2022
• Est. primary completion date: May 31, 2021
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Vascular Diseases

Intervention

Device:
• ElucidVivo
Plaque morphology characterization for predicting non-invasive fractional flow reserve (FFR)

Locations

Country	Name	City	State
n/a

Sponsors (5)

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

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity	the ability of a test to correctly identify patients with low FFR	1 day
Primary	Specificity	the ability of a test to correctly identify people without low FFR	1 day
Secondary	Average Error	Difference of noninvasive result - invasive result	1 day