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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low-dose cardiac CT | Experimental | Patients randomized to this group will be assessed by low-dose cardiac CT protocol. |
|
| Conventional cardiac CT | Other | Patients randomized to this group will be assessed by conventional cardiac CT protocol. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low-dose Cardiac CT protocol | Other | A cardiac CT protocol modified for reduction of radiation exposure
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients having hard events (death, MI) after negative low-dose CCTA findings | Within one month after discharge from emergency department |
| 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 |
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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:
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| Name | Affiliation | Role |
|---|---|---|
| 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 Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul national university Bundang hospital | Seongnam-si | 463-707 | South Korea | |||
| Asan Medical Center |
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| ID | Term |
|---|---|
| D002637 | Chest Pain |
| D054058 | Acute Coronary Syndrome |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Conventional cardiac CT protocol | Other | Conventional CCTA protocol
|
|
| 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. |
| Seoul |
| 138-736 |
| South Korea |
| Seoul national university Boramae medical center | Seoul | 156-707 | South Korea |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |