Clinical trial NCT01770444: Low-Dose Coronary Computed Tomographic Angiography for Early Triage of Acute Chest Pain
Official title: Safety and Efficacy of Implementing Low-Dose Coronary Computed Tomographic Angiography for Early Triage of Acute Chest Pain in Emergency Department
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chest Pain
Keywords: Acute coronary syndrome
Cardiac computed tomographic angiography
Radiation dose reduction
Medical radiation exposure
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2013-01-17
Enrollment: 681
Sex: ALL
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of patients having hard events (death, MI) after negative low-dose CCTA findings
timeFrame: Within one month after discharge from emergency department
Secondary outcomes:
measure: Direct comparison of accuracy (sensitivity, specificity, PPV, NPV) for between low-dose and conventional cardiac CT
timeFrame: One month after discharge from emergency department
measure: Direct comparison of frequency and overall cost of additional tests such as echocardiography, treadmill test, myocardial SPECT and coronary angiography
timeFrame: During 1) index ED visit, which will be an average of 1 day and 2) one-month follow-up period after discharge
measure: Total radiation dose exposed by index CT imaging and additional tests including SPECT and invasive angiography
timeFrame: During 1) index ED visit, which will be an average of 1 day and 2) one-month follow-up period after discharge
measure: Total length of ED and hospital stay
timeFrame: 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.
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Seoul national university Bundang hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul national university Boramae medical center
Study officials:
affiliation: Department of emergency medicine, Seoul national university Bundang hospital
name: Kyuseok Kim, MD
role: STUDY_DIRECTOR
affiliation: Department of radiology, Seoul national university Bundang hospital
name: Sangil Choi, MD
role: STUDY_DIRECTOR
References: