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

Primary Purpose

Chest Pains

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
64 multi-detector computed tomography
Sponsored by
Seoul National University Bundang Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Chest Pains focused on measuring Chest pains, Computed tomography, Emergency

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Seoul National University Bundang hospital

Outcomes

Primary Outcome Measures

Admission rate
Unnecessary admission rate

Secondary Outcome Measures

Stay time in emergency department
Diagnostic accuracy
MACE

Full Information

First Posted
February 5, 2007
Last Updated
June 20, 2011
Sponsor
Seoul National University Bundang Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00431886
Brief Title
Usefulness of 64 Slice Multi-Detector Computed Tomography as a First Diagnostic Approach in Acute Chest Pain Patients
Official Title
Usefulness of 64 Slice Multi-Detector Computed Tomography as a First Diagnostic Approach in Acute Chest Pain Patients
Study Type
Interventional

2. Study Status

Record Verification Date
February 2007
Overall Recruitment Status
Completed
Study Start Date
April 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Seoul National University Bundang Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chest Pains
Keywords
Chest pains, Computed tomography, Emergency

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
64 multi-detector computed tomography
Primary Outcome Measure Information:
Title
Admission rate
Title
Unnecessary admission rate
Secondary Outcome Measure Information:
Title
Stay time in emergency department
Title
Diagnostic accuracy
Title
MACE

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Huk-Jae Chang, MD
Organizational Affiliation
Seoul National University Bundang Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Seoul National University Bundang hospital
City
Sungnam-si
State/Province
Kyungkido
ZIP/Postal Code
463-707
Country
Korea, Republic of

12. IPD Sharing Statement

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

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