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

Not Applicable

Completed

• Conditions: Chest Pain
• Interventions: Other: Conventional cardiac CT protocol; Other: Low-dose Cardiac CT protocol

• Registration Number: NCT01770444
• Lead Sponsor: Seoul National University Hospital

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.

Study Timeline

• Study Start: 2012-12
• Study First Submitted: 2012-12-20
• Study First Submitted QC: 2013-01-15
• Study First Posted: 2013-01-17
• Status Verified: 2015-11
• Primary Completion: 2016-04
• Study Completion: 2016-04
• Last Update Submitted: 2016-11-01
• Last Update Posted: 2016-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 681

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional cardiac CT	Conventional cardiac CT protocol	Patients randomized to this group will be assessed by conventional cardiac CT protocol.
Low-dose cardiac CT	Low-dose Cardiac CT protocol	Patients randomized to this group will be assessed by low-dose cardiac CT protocol.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.
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
Direct comparison of accuracy (sensitivity, specificity, PPV, NPV) for between low-dose and conventional cardiac CT	One month after discharge from emergency department	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.

Trial Locations

Locations (3)

Seoul national university Boramae medical center; 🇰🇷 Seoul, Korea, Republic of

Seoul national university Bundang hospital; 🇰🇷 Seongnam-si, Korea, Republic of

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of