NCT03139006

Application of speCtraL Computed tomogrAphy to impRove specIficity of Cardiac compuTed tomographY

Diagnostic Accuracy of Spectral Computed Tomography for Detection of Flow Limiting Coronary Stenosis Using Fractional Flow Reserve as the Standard of Reference

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 75 (estimated)
• Sponsor: UMC Utrecht · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Cardiovascular disease remains the leading cause of morbidity and mortality worldwide. Coronary computed tomography angiography (CCTA) and, if indicated, invasively measured fractional flow reserve (FFR) is currently used for ruling out significant coronary artery disease. FFRCT is a novel non-invasive technique in which FFR is derived from CT images, however this method is currently, just like CCTA, lacking specificity. Spectral Detector CT (SDCT) is a novel technique whereby a spectrum of monoenergetic images at different kiloelectron Volt (keV) values (40 to 200 keV) can be reconstructed. By using these monoenergetic images, a decrease in blooming and beam-hardening artifacts could be achieved. In addition, SDCT offers the opportunity to assess myocardial iodine distribution and quantification. When combining these factors, we hypothesize more accurate information will be available about the coronary anatomy, degree of stenosis and FFRCT and thereby contribute to a more accurate way for the detection of hemodynamic significant stenosis. Therefore, the aim of this study is to assess the accuracy of SDCT as a non-invasive way for the detection of hemodynamically significant coronary artery stenosis. Objective: The overall objective of this project is to assess the accuracy of SDCT for the detection of flow limiting stenosis in the coronary arteries using invasive FFR as the standard of reference. Whereby different sub-aims (e.g. improvement of FFRCT) are made to answer the overall objective. The secondary objective is to determine the decrease of calcium blooming of calcifications and beam-hardening artifacts and the improvement of myocardial blood volume quantification on SDCT in comparison with conventional CT.

Conditions

• Coronary Stenosis
• Myocardial Ischemia
• Cardiovascular Diseases

Interventions

Type	Name	Description
DEVICE	Dual-layer spectral detector CT	A dual energy CT approach

Timeline

• Start date: 2017-03-29
• Primary completion: 2021-03-29
• Completion: 2021-09-01
• First posted: 2017-05-03
• Last updated: 2018-10-17

Locations

1 site across 1 country: Netherlands

Regulatory

• FDA-regulated device study