Elucidate Vasodilatory Capacity From Histology-Defined Analysis of Coronary CT Angiography
HD-FFRct
1 other identifier
observational
302
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2017
Longer than P75 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
July 13, 2022
CompletedFirst Submitted
Initial submission to the registry
August 30, 2022
CompletedFirst Posted
Study publicly available on registry
September 1, 2022
CompletedSeptember 8, 2022
September 1, 2022
4.4 years
August 30, 2022
September 5, 2022
Conditions
Outcome Measures
Primary Outcomes (2)
Sensitivity
the ability of a test to correctly identify patients with low FFR
1 day
Specificity
the ability of a test to correctly identify people without low FFR
1 day
Secondary Outcomes (1)
Average Error
1 day
Study Arms (2)
Low FFR
Invasive FFR value \<= 0.8
High FFR
Invasive FFR value \> 0.8
Interventions
Plaque morphology characterization for predicting non-invasive fractional flow reserve (FFR)
Eligibility Criteria
Subjects for which a CCTA had been taken within 60 days of invasive coronary angiography with FFR measurements.
You may qualify if:
- 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)
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Elucid Bioimaging Inc.lead
- St. Francis Medical Center, New Jerseycollaborator
- The Christ Hospitalcollaborator
- Medical University of South Carolinacollaborator
- Mie Universitycollaborator
Related 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.
PMID: 33529657BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Andrew J Buckler
Elucid Bioimaging Inc.
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 30, 2022
First Posted
September 1, 2022
Study Start
January 1, 2017
Primary Completion
May 31, 2021
Study Completion
July 13, 2022
Last Updated
September 8, 2022
Record last verified: 2022-09
Data Sharing
- IPD Sharing
- Will not share
We will not share IPD