Low-Dose Coronary Computed Tomographic Angiography for Early Triage of Acute Chest Pain

Safety and Efficacy of Implementing Low-Dose Coronary Computed Tomographic Angiography for Early Triage of Acute Chest Pain in Emergency Department

This study is to see whether the low-dose coronary computed tomographic angiography (CCTA) protocol is as safe and efficacious as conventional-dose protocol in early triage of acute chest pain.

Study Overview

• Status: Completed
• Conditions: Chest Pain
• Intervention / Treatment: Other: Low-dose Cardiac CT protocol; Other: Conventional cardiac CT protocol

Detailed Description

Currently, CCTA is a valuable tool for early triage of low to intermediate risk acute chest pain patients in emergency department. However, it has been criticized for causing unnecessary radiation exposure in the population where its majority has no coronary lesion. A low-dose CCTA protocol comprised with 1) dedicated cardiac imaging protocol (rather than triple rule-out protocol), 2) prospective gating and 3) without additional imaging for calcium scoring will be used to implement the low-dose imaging. We hypothesized that the low-dose CCTA protocol will be as safe and efficacious as conventional dose protocol while decreasing the amount of radiation exposure significantly.

• Study Type: Interventional
• Enrollment (Actual): 681
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seongnam-si, Korea, Republic of, 463-707
    • Seoul National University Bundang Hospital
  • Seoul, Korea, Republic of, 138-736
    • Asan Medical Center
  • Seoul, Korea, Republic of, 156-707
    • Seoul National University Boramae Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

- Patients visiting emergency department for A) acute onset (<12hr) chest pain or equivalent symptoms B) aged between 25-55, C) that requires to rule out acute coronary syndrome.

Exclusion Criteria:

1. Known coronary artery disease and/or any related intervention (STENT, CABG)
2. Elevated cardiac biomarkers (CK-MB, Troponin I)
3. Ischemic ECG changes
4. Documented evidence of low LV systolic function (ejection fraction ≤ 45%)
5. TIMI risk >4
6. Unstable vital sign (e.g. hypoxemia, shock)
7. Patients with contraindication to iodinated contrast and/or beta blockers including renal failure or reactive airway diseases such as COPD or asthma
8. Atrial fibrillation on initial ECGs
9. Active renal disease, serum creatinine ≥1.5 mg/dl
10. Negative coronary angiography or CCTA within 6 months
11. Modified Wells criteria >4 or D-dimer > 0.5ug/mL
12. Suspicious of aortic dissection or D-dimer > 0.5ug/mL

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Low-dose cardiac CT; Patients randomized to this group will be assessed by low-dose cardiac CT protocol.	Other: Low-dose Cardiac CT protocol; A cardiac CT protocol modified for reduction of radiation exposure; Prospective gating; Range: dedicated imaging (below carina to heart base)
Other: Conventional cardiac CT; Patients randomized to this group will be assessed by conventional cardiac CT protocol.	Other: Conventional cardiac CT protocol; Conventional CCTA protocol; Retrospective gating with tube current modulation; Range: dedicated imaging (below carina to heart base)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Proportion of patients having hard events (death, MI) after negative low-dose CCTA findings	Within one month after discharge from emergency department

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Direct comparison of accuracy (sensitivity, specificity, PPV, NPV) for between low-dose and conventional cardiac CT	The diagnostic accuracy of detecting ACS will be assessed using patient chart review and telephone interview (48-72 hours and one month after discharge) as appropriate. ACS event (and MACE) will be adjudicated by independent cardiologists.	One month after discharge from emergency department
Direct comparison of frequency and overall cost of additional tests such as echocardiography, treadmill test, myocardial SPECT and coronary angiography		During 1) index ED visit, which will be an average of 1 day and 2) one-month follow-up period after discharge
Total radiation dose exposed by index CT imaging and additional tests including SPECT and invasive angiography		During 1) index ED visit, which will be an average of 1 day and 2) one-month follow-up period after discharge
Total length of ED and hospital stay		Time spent for index ED visit, which will be an average of 24 hours and total hospital stay until discharge, which will be an average of 7 days.

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Investigators: Study Director: Kyuseok Kim, MD, Department of emergency medicine, Seoul national university Bundang hospital; Study Director: Sangil Choi, MD, Department of radiology, Seoul national university Bundang hospital

Study record dates

Study Major Dates

• Study Start: December 1, 2012
• Primary Completion (Actual): April 1, 2016
• Study Completion (Actual): April 1, 2016

Study Registration Dates

• First Submitted: December 20, 2012
• First Submitted That Met QC Criteria: January 15, 2013
• First Posted (Estimate): January 17, 2013

Study Record Updates

• Last Update Posted (Estimate): November 2, 2016
• Last Update Submitted That Met QC Criteria: November 1, 2016
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Keywords: Acute coronary syndrome; Cardiac computed tomographic angiography; Radiation dose reduction; Medical radiation exposure
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chest Pain; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Cytarabine; Thioguanine
• Other Study ID Numbers: B-1211/177-005