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Completed

NCT Number: NCT05524896

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

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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Key information

Conditions

Vascular Diseases Cardiovascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

ElucidVivo

Device

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

Primary outcomes

  1. Sensitivity

    Time frame: 1 day

    the ability of a test to correctly identify patients with low FFR

  2. Specificity

    Time frame: 1 day

    the ability of a test to correctly identify people without low FFR

Secondary outcomes

  1. Average Error

    Time frame: 1 day

    Difference of noninvasive result - invasive result

Sponsors and collaborators

Lead sponsor

Elucid Bioimaging Inc.

Industry

Collaborators

  • Medical University of South Carolina
  • Mie University
  • St. Francis Medical Center, New Jersey
  • The Christ Hospital

Registry information

Acronym: HD-FFRct

Important dates

Study start
2017
Primary completion
2021
Study completion
2022
First posted
Sep 1, 2022
Registry last updated
Sep 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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