Abstract
BackgroundWith the development of computed tomography (CT) technology, coronary CT angiography can be acquired with low doses of radiation and contrast agent without a loss of diagnostic performance. The primary objective of the CONCENTRATE study is to prove the noninferiority of the enhancement effect of low-concentration contrast agents compared to a high-concentration contrast agent of the coronary artery and myocardium with coronary CT angiography.Methods/DesignThe CONCENTRATE study is a prospective, multicenter, noninferiority, randomized trial evaluating the enhancement effect of low-concentration contrast agents (270 and 320 mg iodine/ml) compared with a high-concentration contrast agent (370 mg iodine/ml) in the coronary artery and myocardium of coronary artery CT angiography. The primary efficacy measurement is the enhancement of coronary arteries as measured in Hounsfield units. The target population comprises 318 patients with suspected coronary artery disease who have been referred for clinically indicated nonemergent coronary CT angiography. Eligible participants are randomized for three different concentrations of the contrast agent in a 1:1:1 allocation ratio to one of three arms. The CONCENTRATE trial is a double-blind study, where the subjects and the outcome assessor are blinded to the concentration of the contrast agent used for coronary the CT angiography. Eight clinical sites in Korea are participating in this trial.DiscussionThe CONCENTRATE study will determine whether low-concentration contrast agents are able to provide diagnostic image quality in coronary CT angiography.Trial registrationNCT02549794. Registered on 14 September 2015.Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-016-1441-y) contains supplementary material, which is available to authorized users.
Highlights
With the development of computed tomography (CT) technology, coronary CT angiography can be acquired with low doses of radiation and contrast agent without a loss of diagnostic performance
The CONCENTRATE study will determine whether low-concentration contrast agents are able to provide diagnostic image quality in coronary CT angiography
Segment-basis analysis, sensitivity, specificity, positive predictive value, negative predictive value, and accuracy of CT angiography for diagnosis of the presence of coronary artery disease (CAD) defined by more than 50 % diameter stenosis compared to invasive coronary angiography will be calculated and compared between the different concentrations of contrast agent by means of a generalized estimating equation based on a binary logistic model
Summary
With the development of computed tomography (CT) technology, coronary CT angiography can be acquired with low doses of radiation and contrast agent without a loss of diagnostic performance. Due to developments in computed tomography (CT) technology, cardiac CT has become very useful as a noninvasive examination technique in the diagnosis of obstructive coronary artery disease (CAD), and the accuracy has increased to more than 90 % [1,2,3,4,5]. A recently introduced method uses a combination of a scan with a low tube-based potential and iterative image reconstruction to reduce both the radiation dose and the amount of contrast agent used for coronary CT angiography [7]. The standard method utilizes a scan with higher tube potential according to patient body mass index (BMI) and image reconstruction by makeshift filtered-back projection under conditions using the same amount of contrast agent. Efficacy studies using low-concentration contrast agents along with low tube potential are being performed [10]
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