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

Chest Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01770444
• Other study ID #: B-1211/177-005
• Status: Completed
• Phase: N/A
• First received: December 20, 2012
• Last updated: November 1, 2016
• Start date: December 2012
• Est. completion date: April 2016

Study information

• Verified date: November 2015
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 681
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 55 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Chest Pain

Intervention

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)
• Conventional cardiac CT protocol
Conventional CCTA protocol Retrospective gating with tube current modulation Range: dedicated imaging (below carina to heart base)

Locations

Country	Name	City	State
Korea, Republic of	Seoul national university Bundang hospital	Seongnam-si
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Seoul national university Boramae medical center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients having hard events (death, MI) after negative low-dose CCTA findings		Within one month after discharge from emergency department	Yes
Secondary	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	Yes
Secondary	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	No
Secondary	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	Yes
Secondary	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.	No