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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Seoul National University Hospital
Sponsor:
Information provided by (Responsible Party):
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01770444
First received: December 20, 2012
Last updated: May 14, 2014
Last verified: May 2014
  Purpose

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 Intervention
Acute Chest Pain
Other: Low-dose Cardiac CT protocol
Other: Conventional cardiac CT protocol

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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

Resource links provided by NLM:


Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • Proportion of patients having hard events (death, MI) after negative low-dose CCTA findings [ Time Frame: Within one month after discharge from emergency department ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: During 1) index ED visit, which will be an average of 1 day and 2) one-month follow-up period after discharge ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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. ] [ Designated as safety issue: No ]

Estimated Enrollment: 681
Study Start Date: December 2012
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  1. Prospective gating
  2. Range: dedicated imaging (below carina to heart base)
Conventional cardiac CT
Patients randomized to this group will be assessed by conventional cardiac CT protocol.
Other: Conventional cardiac CT protocol

Conventional CCTA protocol

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

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) retrospective 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.

  Eligibility

Ages Eligible for Study:   25 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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:

  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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01770444

Contacts
Contact: Kyuseok Kim, MD +82-31-787-7572 dremkks@snubh.org
Contact: Joonghee Kim, MD +82-10-9489-3696 joonghee@me.com

Locations
Korea, Republic of
Seoul national university Bundang hospital Recruiting
Seongnam-si, Korea, Republic of, 463-707
Contact: Kyuseok Kim, MD    +82-31-787-7572    dremkks@snubh.org   
Contact: Joonghee Kim, MD       joonghee@me.com   
Principal Investigator: Sang Il Choi, MD, PhD         
Principal Investigator: Eun Ju Chun, MD, PhD         
Principal Investigator: Chang-Hwan Yoon, MD         
Principal Investigator: Jung-Won Suh, MD         
Seoul national university Boramae medical center Not yet recruiting
Seoul, Korea, Republic of, 156-707
Contact: Jong Hwan Shin, MD       skyshin1@dreamwiz.com   
Principal Investigator: Jong Hwan Shin, skyshin1@dreamwiz.com         
Principal Investigator: Kwang Nam Jin         
Asan Medical Center Not yet recruiting
Seoul, Korea, Republic of, 138-736
Contact: Joon-Won Kang, MD       jwonkang@amc.seoul.kr   
Principal Investigator: Won Young Kim, MD         
Principal Investigator: Joon-Won Kang, MD         
Principal Investigator: Dong Woo Seo, MD         
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
  More Information

No publications provided

Responsible Party: Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01770444     History of Changes
Other Study ID Numbers: B-1211/177-005
Study First Received: December 20, 2012
Last Updated: May 14, 2014
Health Authority: Korea: Food and Drug Administration

Keywords provided by Seoul National University Hospital:
Acute coronary syndrome
Cardiac computed tomographic angiography
Radiation dose reduction
Medical radiation exposure

Additional relevant MeSH terms:
Chest Pain
Pain
Signs and Symptoms
Cytarabine
Thioguanine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 20, 2014