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Completed

NCT Number: NCT01770444

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

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.

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Key information

Age range

20 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul national university Bundang hospital, Seongnam-si, South Korea

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Low-dose Cardiac CT protocol

Other

A cardiac CT protocol modified for reduction of radiation exposure

  • Prospective gating
  • Range: dedicated imaging (below carina to heart base)

Conventional cardiac CT protocol

Other

Conventional CCTA protocol

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

Primary outcomes

  1. 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 outcomes

  1. Direct comparison of accuracy (sensitivity, specificity, PPV, NPV) for between low-dose and conventional cardiac CT

    Time frame: 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.

  2. 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

  3. 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

  4. 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.

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Jan 17, 2013
Registry last updated
Nov 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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