This observational study evaluated how well the AutocathFFR software measures fractional flow reserve (FFR) from coronary angiogram images. AutocathFFR runs on standard two-dimensional (2D) angiograms taken during cardiac catheterization. Researchers compared its results to invasive FFR, the gold standard. The main questions were: * What is the sensitivity of AutocathFFR per vessel compared to invasive FFR? * What is the specificity of AutocathFFR per vessel compared to invasive FFR? A vessel is scored "positive" when FFR ≤ 0.80 and "negative" when FFR \> 0.80. Researchers retrospectively analyzed consecutive angiograms from 4 sites in the United States. 278 patients (300 vessels) were analyzed with the AutocathFFR software, and 277 patients (297 vessels) completed AutocathFFR analysis. Participants were adults with stable angina, unstable angina, or non-ST-elevation myocardial infarction (NSTEMI) who underwent invasive coronary angiography and invasive FFR.
Study Type
OBSERVATIONAL
Enrollment
277
MedHub AutocathFFR is a software device for the analysis of previously acquired angiography data in Digital Imaging and Communications in Medicine (DICOM) format. The AutocathFFR value is computed from standard 2D angiography images, taken from two different views, retrieved from the C-arm angiography system. The FFR value is calculated using a machine-learning and computer vision algorithm. The result is intended to support the functional evaluation of coronary artery disease.
MedStar Washington Hospital Center
Washington D.C., District of Columbia, United States
Emory University Hospital
Atlanta, Georgia, United States
Northeast Georgia Medical Center
Gainesville, Georgia, United States
University of Virginia Health System
Charlottesville, Virginia, United States
Per-Vessel Sensitivity of AutocathFFR vs. Invasive FFR
Sensitivity of the dichotomously scored AutocathFFR per vessel compared to the gold standard, invasive FFR measurements, where an FFR ≤ 0.80 is scored "positive" and an FFR \> 0.80 is considered "negative". Performance goal: lower bound of one-sided 97.5% confidence interval must exceed 80%.
Time frame: Day 1 (the day of the index invasive coronary angiography procedure)
Per-Vessel Specificity of AutocathFFR vs. Invasive FFR
Specificity of the dichotomously scored AutocathFFR per vessel compared to the gold standard, invasive FFR measurements, where an FFR ≤ 0.80 is scored "positive" and an FFR \> 0.80 is considered "negative". Performance goal: lower bound of one-sided 97.5% confidence interval must exceed 80%.
Time frame: Day 1 (the day of the index invasive coronary angiography procedure)
Per-Patient Sensitivity and Specificity
Per-patient sensitivity and specificity of the dichotomously scored AutocathFFR per vessel compared to gold standard, invasive FFR, where an FFR ≤ 0.80 is scored "positive" and an FFR \> 0.80 is considered "negative".
Time frame: Day 1 (the day of the index invasive coronary angiography procedure)
Sensitivity, Specificity, PPV, and NPV Including "No FFR" Output
Sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of AutocathFFR, including cases where the device produces a "No FFR" output (failure to compute), compared to the gold standard, invasive FFR.
Time frame: Day 1 (the day of the index invasive coronary angiography procedure)
Device Success Rate
Device success, measured as the ratio of completed versus initiated AutocathFFR index calculations.
Time frame: Through study completion, up to 8 months
Device-Related Malfunctions
Number of device-related malfunctions recorded throughout the study, summarized descriptively.
Time frame: Through study completion, up to 8 months
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