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

Primary Purpose

Chest Pain

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Low-dose Cardiac CT protocol
Conventional cardiac CT protocol
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Chest Pain focused on measuring Acute coronary syndrome, Cardiac computed tomographic angiography, Radiation dose reduction, Medical radiation exposure

Eligibility Criteria

20 Years - 55 Years (Adult)All SexesDoes not accept 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:

  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

Sites / Locations

  • Seoul national university Bundang hospital
  • Asan Medical Center
  • Seoul national university Boramae medical center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Low-dose cardiac CT

Conventional cardiac CT

Arm Description

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

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

Outcomes

Primary Outcome Measures

Proportion of patients having hard events (death, MI) after negative low-dose CCTA findings

Secondary Outcome Measures

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.
Direct comparison of frequency and overall cost of additional tests such as echocardiography, treadmill test, myocardial SPECT and coronary angiography
Total radiation dose exposed by index CT imaging and additional tests including SPECT and invasive angiography
Total length of ED and hospital stay

Full Information

First Posted
December 20, 2012
Last Updated
November 1, 2016
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01770444
Brief Title
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

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
December 2012 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
April 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chest Pain
Keywords
Acute coronary syndrome, Cardiac computed tomographic angiography, Radiation dose reduction, Medical radiation exposure

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
681 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Low-dose cardiac CT
Arm Type
Experimental
Arm Description
Patients randomized to this group will be assessed by low-dose cardiac CT protocol.
Arm Title
Conventional cardiac CT
Arm Type
Other
Arm Description
Patients randomized to this group will be assessed by conventional cardiac CT protocol.
Intervention Type
Other
Intervention Name(s)
Low-dose Cardiac CT protocol
Intervention Description
A cardiac CT protocol modified for reduction of radiation exposure Prospective gating Range: dedicated imaging (below carina to heart base)
Intervention Type
Other
Intervention Name(s)
Conventional cardiac CT protocol
Intervention Description
Conventional CCTA protocol Retrospective gating with tube current modulation Range: dedicated imaging (below carina to heart base)
Primary Outcome Measure Information:
Title
Proportion of patients having hard events (death, MI) after negative low-dose CCTA findings
Time Frame
Within one month after discharge from emergency department
Secondary Outcome Measure Information:
Title
Direct comparison of accuracy (sensitivity, specificity, PPV, NPV) for between low-dose and conventional cardiac CT
Description
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.
Time Frame
One month after discharge from emergency department
Title
Direct comparison of frequency and overall cost of additional tests such as echocardiography, treadmill test, myocardial SPECT and coronary angiography
Time Frame
During 1) index ED visit, which will be an average of 1 day and 2) one-month follow-up period after discharge
Title
Total radiation dose exposed by index CT imaging and additional tests including SPECT and invasive angiography
Time Frame
During 1) index ED visit, which will be an average of 1 day and 2) one-month follow-up period after discharge
Title
Total length of ED and hospital stay
Time Frame
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kyuseok Kim, MD
Organizational Affiliation
Department of emergency medicine, Seoul national university Bundang hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Sangil Choi, MD
Organizational Affiliation
Department of radiology, Seoul national university Bundang hospital
Official's Role
Study Director
Facility Information:
Facility Name
Seoul national university Bundang hospital
City
Seongnam-si
ZIP/Postal Code
463-707
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of
Facility Name
Seoul national university Boramae medical center
City
Seoul
ZIP/Postal Code
156-707
Country
Korea, Republic of

12. IPD Sharing Statement

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

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