ELUCIDATE FFRct Study

Status unconfirmed

Conditions studied: Coronary Artery Disease

In brief

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.

Key facts

Study ID

NCT06018194

Run by

Elucid Bioimaging Inc.

People needed

350

Starts

2023-09-01

Expected to finish

2024-07-31

Last updated by the study team

2024-02-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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.

Where it is running

• Midwest Heart and Vascular Specialists — Overland Park, Kansas, United States (enrolling)
• University of Virginia — Charlottesville, Virginia, United States (enrolling)
• Parkview Health — Fort Wayne, Indiana, United States
• Cardiovascular Medical Group of Southern California — Beverly Hills, California, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• Centennial Heart — Nashville, Tennessee, United States
• Ascension Medical Group — Nashville, Tennessee, United States
• Valley Health System — Ridgewood, New Jersey, United States
• Piedmont Healthcare — Atlanta, Georgia, United States

Full record on ClinicalTrials.gov

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