KMID : 1100620170040040208
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Clinical and Experimental Emergency Medicine 2017 Volume.4 No. 4 p.208 ~ p.213
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SEALONE (Safety and Efficacy of Coronary Computed Tomography Angiography with Low Dose in Patients Visiting Emergency Room) trial: study protocol for a randomized controlled trial
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Kim Joong-Hee
Kang Joon-Won Kim Kyu-Seok Choi Sang-Il Chun Eun-Ju Kim Yeo-Goon Kim Won-Young Seo Dong-Woo Shin Jong-Hwan Lee Hui-Jai Jin Kwang-Nam Ahn So-Yeon Hwang Seun-Deuk Kim Kwang-Pyo Jeong Ru-Bi Ha Sang-Ook Choi Byung-Ho Yoon Chang-Hwan Suh Jung-Won Kim Hack-Lyoung Kim Ju-Kyoung Jang Su-jin Seo Ji-Seon
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Abstract
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Objective: Chest pain is one of the most common complaints in the emergency department (ED). Cardiac computed tomography angiography (CCTA) is a frequently used tool for the early triage of patients with low- to intermediate-risk acute chest pain. We present a study protocol for a multicenter prospective randomized controlled clinical trial testing the hypothesis that a low-dose CCTA protocol using prospective electrocardiogram (ECG)-triggering and limited-scan range can provide sufficient diagnostic safety for early triage of patients with acute chest pain.
Methods: The trial will include 681 younger adult (aged 20 to 55) patients visiting EDs of three academic hospitals for acute chest pain or equivalent symptoms who require further evaluation to rule out acute coronary syndrome. Participants will be randomly allocated to either low-dose or conventional CCTA protocol at a 2:1 ratio. The low-dose group will undergo CCTA with prospective ECG-triggering and restricted scan range from sub-carina to heart base. The conventional protocol group will undergo CCTA with retrospective ECG-gating covering the entire chest. Patient disposition is determined based on computed tomography findings and clinical progression and all patients are followed for a month. The primary objective is to prove that the chance of experiencing any hard event within 30 days after a negative low-dose CCTA is less than 1%. The secondary objectives are comparisons of the amount of radiation exposure, ED length of stay and overall cost.
Results: and Conclusion : Our low-dose protocol is readily applicable to current multi-detector computed tomography devices. If this study proves its safety and efficacy, dose-reduction without purchasing of expensive newer devices would be possible.
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KEYWORD
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Computed tomography, Coronary angiography, Chest pain, Radiation
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