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

NCT01770444 | Completed DMC

• 1 other identifier: B-1211/177-005
• Study Type: interventional
• Target: 681
• Locations: 1 country
• Sites: 3

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.

Conditions

Chest Pain

Keywords

Acute coronary syndrome; Cardiac computed tomographic angiography; Radiation dose reduction; Medical radiation exposure

Outcome Measures

Primary Outcomes (1)

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

  Within one month after discharge from emergency department

Secondary Outcomes (4)

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

  One month after discharge from emergency department

• 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.

Study Arms (2)

Low-dose cardiac CT

EXPERIMENTAL

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

Other: Low-dose Cardiac CT protocol

Conventional cardiac CT

OTHER

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

Other: Conventional cardiac CT protocol

Interventions

Low-dose Cardiac CT protocol OTHER

A cardiac CT protocol modified for reduction of radiation exposure 1. Prospective gating 2. Range: dedicated imaging (below carina to heart base)

Low-dose cardiac CT

Conventional cardiac CT protocol OTHER

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

Conventional cardiac CT

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• \- 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (3)

Seoul national university Bundang hospital

Seongnam-si, 463-707, South Korea

Location

Asan Medical Center

Seoul, 138-736, South Korea

Location

Seoul national university Boramae medical center

Seoul, 156-707, South Korea

Location

MeSH Terms

Conditions

Chest Pain; Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• 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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2012
• First Posted: January 17, 2013
• Study Start: December 1, 2012
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: November 2, 2016

Record last verified: 2015-11

Locations

KR (3)