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

Sponsor

Seoul National University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT01770444

Collaborator

(none)

681

Enrollment

Locations

Arms

Duration (Months)

227

Patients Per Site

5.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chest Pain	Other: Low-dose Cardiac CT protocol Other: Conventional cardiac CT protocol	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

681 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Diagnostic

Official Title:

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

Study Start Date :

Dec 1, 2012

Actual Primary Completion Date :

Apr 1, 2016

Actual Study Completion Date :

Apr 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Low-dose cardiac CT Patients randomized to this group will be assessed by low-dose cardiac CT protocol.	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)
Other: Conventional cardiac CT Patients randomized to this group will be assessed by conventional cardiac CT protocol.	Other: Conventional cardiac CT protocol Conventional CCTA protocol Retrospective gating with tube current modulation Range: dedicated imaging (below carina to heart base)

Arm

Intervention/Treatment

Experimental: Low-dose cardiac CT

Patients randomized to this group will be assessed by low-dose cardiac CT protocol.

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)

Other: Conventional cardiac CT

Patients randomized to this group will be assessed by conventional cardiac CT protocol.

Other: Conventional cardiac CT protocol

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

Outcome Measures

Primary Outcome Measures

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

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.
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.]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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:

Known coronary artery disease and/or any related intervention (STENT, CABG)
Elevated cardiac biomarkers (CK-MB, Troponin I)
Ischemic ECG changes
Documented evidence of low LV systolic function (ejection fraction ≤ 45%)
TIMI risk >4
Unstable vital sign (e.g. hypoxemia, shock)
Patients with contraindication to iodinated contrast and/or beta blockers including renal failure or reactive airway diseases such as COPD or asthma
Atrial fibrillation on initial ECGs
Active renal disease, serum creatinine ≥1.5 mg/dl
Negative coronary angiography or CCTA within 6 months
Modified Wells criteria >4 or D-dimer > 0.5ug/mL
Suspicious of aortic dissection or D-dimer > 0.5ug/mL

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Seoul national university Bundang hospital	Seongnam-si	Korea, Republic of	463-707
2	Asan Medical Center	Seoul	Korea, Republic of	138-736
3	Seoul national university Boramae medical center	Seoul	Korea, Republic of	156-707

Sponsors and Collaborators

Seoul National University Hospital

Investigators

Study Director: 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