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Published on: April 13, 2015
Rationale and design of the HeartFlowNXT (HeartFlow analysis of coronary blood flow using CT angiography: NeXt sTeps)
Sara Gaur1, Stephan Achenbach, Jonathon Leipsic
1Department of Cardiology, Aarhus University Hospital, Brendstrupgaardsvej 100, 8200 Aarhus N, Skejby, Denmark.
Insights
Computed fractional flow reserve (FFRCT) from coronary CT angiography shows promise for identifying significant coronary artery disease. This study evaluates FFRCT
Area of Science:
- Cardiovascular Imaging
- Interventional Cardiology
- Medical Device Technology
Background:
- Coronary CT angiography (CTA) visualizes coronary artery disease but lacks physiological information to identify ischemia-causing lesions.
- Computed fractional flow reserve (FFRCT) from CTA images offers a noninvasive method to assess lesion-specific ischemia.
- The diagnostic performance of FFRCT compared to invasive fractional flow reserve (FFR) requires further establishment.
Purpose of the Study:
- To evaluate the diagnostic performance of FFRCT for detecting and excluding flow-limiting coronary stenoses.
- To compare the diagnostic accuracy of FFRCT against coronary CTA alone in identifying hemodynamically significant coronary lesions.
- To establish FFRCT as a reliable noninvasive tool for assessing coronary artery disease.
Main Methods:
- Prospective, international, multicenter study (HeartFlowNXT) involving 270 subjects.
- Coronary CTA and invasive coronary angiography with FFR performed on all participants.
- Blinded core laboratory interpretation for FFRCT, invasive angiography, and FFR measurements.
Main Results:
- The study aims to determine the diagnostic performance of FFRCT versus coronary CTA alone.
- Secondary endpoints include assessment of diagnostic accuracy, sensitivity, specificity, PPV, and NPV of FFRCT.
- FFR values ≤ 0.80 will define ischemia-causing lesions.
Conclusions:
- FFRCT holds potential for noninvasively assessing hemodynamically significant coronary lesions.
- This research will clarify the role of FFRCT in the diagnosis of coronary artery disease.
- Establishing FFRCT's diagnostic performance is crucial for its clinical integration.
Introduction:
Coronary CT angiography (CTA) is an established noninvasive method for visualization of coronary artery disease. However, coronary CTA lacks physiological information; thus, it does not permit differentiation of ischemia-causing lesions. Recent advances in computational fluid dynamic techniques applied to standard coronary CTA images allow for computation of fractional flow reserve (FFR), a measure of lesion-specific ischemia. The diagnostic performance of computed FFR (FFRCT) compared with invasively measured FFR is not yet fully established.
Methods/Design:
HeartFlowNXT (HeartFlow analysis of coronary blood flow using coronary CT angiography: NeXt sTeps) is a prospective, international, multicenter study designed to evaluate the diagnostic performance of FFRCT for the detection and exclusion of flow-limiting obstructive coronary stenoses, as defined by invasively measured FFR as the reference standard. FFR values ≤ 0.80 will be considered to be ischemia causing. All subjects (N = 270; 10 investigative sites) will undergo coronary CTA (single- or dual-source CT scanners with a minimum of 64 slices) and invasive coronary angiography with FFR. Patients with insufficient quality of coronary CTA will be excluded. Blinded core laboratory interpretation will be performed for FFRCT, invasive coronary angiography, and FFR. Stenosis severity by coronary CTA will be evaluated by the investigative site in addition to a blinded core laboratory interpretation. The primary objective of the study is to determine the diagnostic performance of FFRCT compared with coronary CTA alone to noninvasively determine the presence of hemodynamically significant coronary lesions. The secondary end point comprises assessment of diagnostic accuracy, sensitivity, specificity, positive predictive value, and negative predictive value of FFRCT.
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