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- Title
Comparison of coronary computed tomography angiography image quality with high- and low-concentration contrast agents (CONCENTRATE): study protocol for a randomized controlled trial.
- Authors
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; Im, Dong Jin; Kim, Yun-Hyeon; Choo, Ki Seok; Kang, Joon-Won; Jung, Jung Im; Won, Yoodong; Kim, Hyo Rim; Chung, Myung Hee; Han, Kyunghwa; Choi, Byoung Wook
- Abstract
<bold>Background: </bold>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.<bold>Methods/design: </bold>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.<bold>Discussion: </bold>The CONCENTRATE study will determine whether low-concentration contrast agents are able to provide diagnostic image quality in coronary CT angiography.<bold>Trial Registration: </bold>NCT02549794 . Registered on 14 September 2015.
- Subjects
SOUTH Korea; COMPUTED tomography; ANGIOGRAPHY; CORONARY disease; CONTRAST media; RADIATION; COMPARATIVE studies; CORONARY arteries; CORONARY circulation; DIAGNOSTIC imaging; EXPERIMENTAL design; GROWTH factors; HEART diseases; HEART function tests; LONGITUDINAL method; RESEARCH methodology; MEDICAL cooperation; RESEARCH protocols; COMPUTERS in medicine; RESEARCH; STATISTICAL sampling; EVALUATION research; RANDOMIZED controlled trials; PREDICTIVE tests; BLIND experiment; CORONARY angiography; MULTIDETECTOR computed tomography; DRUG administration; DRUG dosage
- Publication
Trials, 2016, Vol 17, p1
- ISSN
1745-6215
- Publication type
journal article
- DOI
10.1186/s13063-016-1441-y