Usefulness of 64 Slice Multi-Detector Computed Tomography as a First Diagnostic Approach in Acute Chest Pain Patients

June 20, 2011 updated by: Seoul National University Bundang Hospital
The purpose of this study is to determine the usefulness of 64 slice multi-detector computed tomography as a first diagnostic approach in acute chest pain patients in emergency room

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

We prospectively enrolled the patients with acute chest pain who visited ED. Exclusion criteria were myocardial infarction (MI) with ST elevation, unstable vital sign, uncontrolled arrhythmia, renal dysfunction, hypersensitivity to contrast media and pregnancy. Patients were allocated into 3 categories based on history, physical exam, and electrocardiogram: 1) definite angina with uncertainty of regarding MI (high risk), 2) probable angina (intermediate risk), 3) low likelihood of angina (low risk), and then randomized to either receive MDCT immediately (MDCT group), or not (control). We compared diagnostic accuracy, length of stay in ER, admission rate, and major adverse cardiac events (MACE) and clinical diagnosis in 1 month after discharge from ED.

Study Type

Interventional

Enrollment (Anticipated)

400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Kyungkido
      • Sungnam-si, Kyungkido, Korea, Republic of, 463-707
        • Seoul National University Bundang Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Acute chest pain patient visiting emergency room

Exclusion Criteria:

  • unstable vital sign
  • renal failure
  • ST elevation myocardial infarction
  • uncontrolled arrhythmia
  • hypersensitivity to contrast dye
  • clinically no possibility of angina

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Admission rate
Unnecessary admission rate

Secondary Outcome Measures

Outcome Measure
MACE
Diagnostic accuracy
Stay time in emergency department

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Bundang Hospital

Investigators

  • Study Director: Huk-Jae Chang, MD, Seoul National University Bundang Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2006

Study Completion (Actual)

December 1, 2007

Study Registration Dates

First Submitted

February 5, 2007

First Submitted That Met QC Criteria

February 5, 2007

First Posted (Estimate)

February 6, 2007

Study Record Updates

Last Update Posted (Estimate)

June 21, 2011

Last Update Submitted That Met QC Criteria

June 20, 2011

Last Verified

February 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B-0603/031-009

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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