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Comparison of coronary computed tomography angiography image quality with high- and low-concentration contrast agents (CONCENTRATE): study protocol for a randomized controlled trial

 Dong Jin Im  ;  Yun-Hyeon Kim  ;  Ki Seok Choo  ;  Joon-Won Kang  ;  Jung Im Jung  ;  Yoodong Won  ;  Hyo Rim Kim  ;  Myung Hee Chung  ;  Kyunghwa Han  ;  Byoung Wook Choi 
 TRIALS, Vol.17(1) : 315, 2016 
Journal Title
Issue Date
Clinical Protocols ; Computed Tomography Angiography/methods* ; Contrast Media/administration & dosage* ; Coronary Angiography/methods* ; Coronary Circulation ; Coronary Vessels/diagnostic imaging* ; Coronary Vessels/physiopathology ; Double-Blind Method ; Heart Diseases/diagnostic imaging* ; Heart Diseases/physiopathology ; Humans ; Iopamidol/administration & dosage* ; Multidetector Computed Tomography/methods* ; Myocardial Perfusion Imaging/methods* ; Predictive Value of Tests ; Prospective Studies ; Radiographic Image Interpretation, Computer-Assisted ; Republic of Korea ; Research Design ; Triiodobenzoic Acids/administration & dosage*
CAD ; CCTA ; Computed tomography ; Contrast agent ; Coronary artery disease ; Coronary computed tomography angiography ; Radiation
BACKGROUND: 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 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/DESIGN: The 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. DISCUSSION: The CONCENTRATE study will determine whether low-concentration contrast agents are able to provide diagnostic image quality in coronary CT angiography. TRIAL REGISTRATION: NCT02549794 . Registered on 14 September 2015.
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1. College of Medicine (의과대학) > Dept. of Radiology (영상의학교실) > 1. Journal Papers
Yonsei Authors
Im, Dong Jin(임동진) ORCID logo https://orcid.org/0000-0001-8139-5646
Choi, Byoung Wook(최병욱) ORCID logo https://orcid.org/0000-0002-8873-5444
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