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

Seoul National University Hospital681 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

SINGLE

Enrollment

681

Conditions

Chest Pain

Interventions

Low-dose Cardiac CT protocolOTHER

A cardiac CT protocol modified for reduction of radiation exposure 1. Prospective gating 2. Range: dedicated imaging (below carina to heart base)

Conventional cardiac CT protocolOTHER

Conventional CCTA protocol 1. Retrospective gating with tube current modulation 2. Range: dedicated imaging (below carina to heart base)

Eligibility

Sex: ALLMin age: 20 YearsMax age: 55 Years

Medical Language ↔ Plain English

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

Locations (3)

Seoul national university Bundang hospital

Seongnam-si, South Korea

Asan Medical Center

Seoul, South Korea

Seoul national university Boramae medical center

Seoul, South Korea

Outcomes

Primary Outcomes

Proportion of patients having hard events (death, MI) after negative low-dose CCTA findings

Time frame: Within one month after discharge from emergency department

Secondary Outcomes

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.

Time frame: 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

Time frame: 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

Time frame: 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 frame: 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.

Data from ClinicalTrials.gov

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