ELUCIDATE FFRct Study

Sponsor

Elucid Bioimaging Inc. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT06018194

Collaborator

Lundquist Institute at Harbor-UCLA Medical Center (Other)

350

Enrollment

Locations

Anticipated Duration (Months)

38.9

Patients Per Site

7.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The goal of this study is to evaluate the diagnostic accuracy of a novel plaque-based coronary CT angiography (CCTA) fractional flow reserve (FFRct) software device for the estimation of invasive fractional flow reserve (FFR).

Researchers will compare the Elucid plaque-based FFRct analysis to invasively measured FFR in patients who have previously undergone CCTA and invasively assessed FFR.

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease	Device: ElucidVivo

Detailed Description

Invasive fractional flow reserve is a clinically validated measure of lesion-specific ischemia and is preferred over visual estimation of diameter stenosis for clinical decision-making regarding coronary revascularization in patients with stable clinical presentations. Fractional flow reserve derived from coronary computed tomography angiography (FFRct) using computational fluid dynamic (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 CCTA. However, CFD-based FFRct is calculated based predominately on detailed coronary lumen geometry. It is understood that the burden and type of coronary atherosclerosis, in addition to lumen geometry, significantly impacts the vasodilatory capacity of the coronary endothelium.

Preliminary studies suggest that invasive FFR can be accurately estimated based on the quantification of coronary plaque burden and the assessment of plaque composition. Previously, the investigators have demonstrated that a novel plaque-based FFRct approach, using a histologically validated software (ElucidVivoTM) for the measurement of plaque morphology (volume, plaque risk characteristics, and stenosis) to train a deep-learning model, was shown to be accurate and superior to lumen stenosis for predicting invasive FFR in a single-site feasibility study.

In this study, the investigators seek to assess the diagnostic accuracy of the Elucid plaque-based FFRct software to estimate invasive FFR in patients at multiple centers.

Study Design

Study Type:

Observational

Anticipated Enrollment :

350 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

The ELUCIDATE FFRct Study

Anticipated Study Start Date :

Sep 1, 2023

Anticipated Primary Completion Date :

Jan 31, 2024

Anticipated Study Completion Date :

Jan 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Low FFR Invasive FFR <= 0.80	Device: ElucidVivo Plaque morphology characterization on coronary CTA for predicting fractional flow reserve (FFRct)
High FFR Invasive FFR > 0.80	Device: ElucidVivo Plaque morphology characterization on coronary CTA for predicting fractional flow reserve (FFRct)

Arm

Intervention/Treatment

Low FFR

Invasive FFR <= 0.80

Device: ElucidVivo

Plaque morphology characterization on coronary CTA for predicting fractional flow reserve (FFRct)

High FFR

Invasive FFR > 0.80

Device: ElucidVivo

Plaque morphology characterization on coronary CTA for predicting fractional flow reserve (FFRct)

Outcome Measures

Primary Outcome Measures

Sensitivity of FFRct versus invasive FFR for detecting invasive FFR ≤ 0.80 [1 day]
Per-vessel
Specificity of FFRct versus invasive FFR for detecting invasive FFR ≤ 0.80 [1 day]
Per-vessel

Secondary Outcome Measures

Sensitivity of FFRct for detecting invasive FFR ≤ 0.80 [1 day]
Per-patient
Specificity of FFRct for detecting invasive FFR ≤ 0.80 [1 day]
Per-patient
Area under the receiver-operating characteristic curve (AUC) of FFRct for detecting invasive FFR ≤ 0.80 [1 day]
Per-vessel
Area under the receiver-operating characteristic curve (AUC) of FFRct for detecting invasive FFR ≤ 0.80 [1 day]
Per-patient
Accuracy of FFRct for detecting invasive FFR ≤ 0.80 [1 day]
Per-vessel
Accuracy of FFRct for detecting invasive FFR ≤ 0.80 [1 day]
Per-patient
Negative predictive value of FFRct for detecting invasive FFR ≤ 0.80 [1 day]
Per-vessel
Negative predictive value of FFRct for detecting invasive FFR ≤ 0.80 [1 day]
Per-patient
Positive predictive value of FFRct for detecting invasive FFR ≤ 0.80 [1 day]
Per-vessel
Positive predictive value of FFRct for detecting invasive FFR ≤ 0.80 [1 day]
Per-patient

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Adults >=18 years with at least one 30-90% stenosis on CCTA (>64- detector row) performed within 60 days of undergoing invasive FFR.

Exclusion Criteria:

History of coronary revascularization with coronary artery bypass graft (CABG) surgery and/or percutaneous coronary intervention (PCI) (stent or balloon angioplasty) prior to CCTA and invasive FFR.
History of myocardial infarction prior to CCTA and invasive FFR.
Known complex congenital heart disease.
Existing pacemaker or internal defibrillator lead implantation(s).
Existing prosthetic heart valve.
Absence of CCTA Digital Imaging and Communications in Medicine (DICOM) data for analysis.
Absence of invasive coronary angiography imaging or adequate description defining the position of the invasive FFR wire location.
Poor CCTA image quality that does not meet Elucid image processing requirements for plaque and FFRct.
Absence of study date for CCTA or invasive FFR.
Interval clinical myocardial infarction, diagnosis of decompensated heart failure, stroke, or coronary revascularization procedure between CCTA and invasive FFR.
Non-diagnostic CCTA or invasive FFR. Studies where the results of the study were deemed non-diagnostic for clinical decision-making will be excluded.
CCTA or invasive FFR studies performed prior to 1 January 2016.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cardiovascular Medical Group of Southern California	Beverly Hills	California	United States	90210
2	Piedmont Healthcare	Atlanta	Georgia	United States	30309
3	Parkview Health	Fort Wayne	Indiana	United States	46845
4	Midwest Heart and Vascular Specialists	Overland Park	Kansas	United States	66211
5	Valley Health System	Ridgewood	New Jersey	United States	07450
6	Cleveland Clinic	Cleveland	Ohio	United States	44195
7	Centennial Heart	Nashville	Tennessee	United States	37203
8	Ascension Medical Group	Nashville	Tennessee	United States	37205
9	University of Virginia	Charlottesville	Virginia	United States	22908