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

This study has been completed.
Sponsor:
Information provided by:
Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier:
NCT00431886
First received: February 5, 2007
Last updated: June 20, 2011
Last verified: February 2007
  Purpose

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


Condition Intervention
Chest Pains
Procedure: 64 multi-detector computed tomography

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Usefulness of 64 Slice Multi-Detector Computed Tomography as a First Diagnostic Approach in Acute Chest Pain Patients

Resource links provided by NLM:


Further study details as provided by Seoul National University Bundang Hospital:

Primary Outcome Measures:
  • Admission rate
  • Unnecessary admission rate

Secondary Outcome Measures:
  • Stay time in emergency department
  • Diagnostic accuracy
  • MACE

Estimated Enrollment: 400
Study Start Date: April 2006
Study Completion Date: December 2007
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.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  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: NCT00431886

Locations
Korea, Republic of
Seoul National University Bundang hospital
Sungnam-si, Kyungkido, Korea, Republic of, 463-707
Sponsors and Collaborators
Seoul National University Bundang Hospital
Investigators
Study Director: Huk-Jae Chang, MD Seoul National University Bundang Hospital
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00431886     History of Changes
Other Study ID Numbers: B-0603/031-009
Study First Received: February 5, 2007
Last Updated: June 20, 2011
Health Authority: Korea: Food and Drug Administration

Keywords provided by Seoul National University Bundang Hospital:
Chest pains
Computed tomography
Emergency

Additional relevant MeSH terms:
Chest Pain
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on October 30, 2014