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

Chest Pains Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00431886
• Other study ID #: B-0603/031-009
• Status: Completed
• Phase: N/A
• First received: February 5, 2007
• Last updated: June 20, 2011
• Start date: April 2006
• Est. completion date: December 2007

Study information

• Verified date: February 2007
• Source: Seoul National University Bundang Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Chest Pain
• Chest Pains

Intervention

Procedure:
• 64 multi-detector computed tomography

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang hospital	Sungnam-si	Kyungkido

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Bundang Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Admission rate
Primary	Unnecessary admission rate
Secondary	Stay time in emergency department
Secondary	Diagnostic accuracy
Secondary	MACE