Clin Exp Emerg Med.  2017 Dec;4(4):208-213. 10.15441/ceem.17.245.

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

Affiliations
  • 1Department of Emergency Medicine, Seoul National University Bundang Hospital, Seongnam, Korea. dremkks@snubh.org
  • 2Department of Radiology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.
  • 3Department of Radiology, Seoul National University Bundang Hospital, Seongnam, Korea.
  • 4Department of Emergency Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.
  • 5Department of Emergency Medicine, Seoul Metropolitan Government-Seoul National University Boramae Medical Center, Seoul, Korea.
  • 6Department of Radiology, Seoul Metropolitan Government-Seoul National University Boramae Medical Center, Seoul, Korea.
  • 7Medical Research Collaborating Center, Seoul National University Bundang Hospital, Seongnam, Korea.
  • 8Department of Preventive Medicine, Seoul National University School of Public Health, Seoul, Korea.
  • 9Department of Nuclear Engineering, Kyung Hee University, Suwon, Korea.
  • 10Department of Emergency Medicine, Bundang Jesaeng General Hospital, Seongnam, Korea.
  • 11Department of Emergency Medicine, Hallym University Sacred Heart Hospital, Hallym University College of Medicine, Anyang, Korea.
  • 12Department of Cardiology, Seoul National University Bundang Hospital, Seongnam, Korea.
  • 13Department of Cardiology, Seoul Metropolitan Government-Seoul National University Boramae Medical Center, Seoul, Korea.

Abstract


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.

Keyword

Computed tomography; Coronary angiography; Chest pain; Radiation

MeSH Terms

Acute Coronary Syndrome
Adult
Angiography*
Chest Pain
Coronary Angiography
Electrocardiography
Emergencies*
Emergency Service, Hospital
Heart
Humans
Length of Stay
Prospective Studies
Radiation Exposure
Retrospective Studies
Thorax
Triage
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