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Coronary Computed Tomography (CT) Angiography Versus Standard Therapy in the Emergency Room

Primary Purpose

Chest Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CCTA (coronary computed tomography angiography)
Control section
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chest Pain

Eligibility Criteria

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

Inclusion Criteria:

  • 25 years of age or older
  • Experiencing chest pain

Exclusion Criteria:

  • Pregnant
  • At high risk for ACS (Acute Coronary Syndrome)

Sites / Locations

  • University of Michigan Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

chest pain

Arm Description

CCTA (Coronary computed tomography angiography)

Outcomes

Primary Outcome Measures

To assess the usefulness of CCTA (coronary computed tomography angiography)in the emergency room setting to diagnose/predict the outcome of patients w/chest pain who have low to moderate risk of heart disease.

Secondary Outcome Measures

To determine if the use of CCTA (coronary computed tomography angiography)is more cost effective than the current standard of care treatments being used.

Full Information

First Posted
February 17, 2009
Last Updated
December 4, 2012
Sponsor
University of Michigan
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1. Study Identification

Unique Protocol Identification Number
NCT00846469
Brief Title
Coronary Computed Tomography (CT) Angiography Versus Standard Therapy in the Emergency Room
Official Title
64 Slice Coronary CT Angiography vs. Standard Therapy in the Emergency Room: Determining Cost-effectiveness and Predicting Clinical Outcome in Patients With Low and Moderate Risk for Acute Coronary Syndrome.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to determine the usefulness of CCTA (Coronary Computed Tomography Angiography) in the emergency room setting to diagnose and predict the outcome of patients with chest pain who have a low to moderate risk of heart disease. And to also determine if the use of CCTA(Coronary Computed Tomography Angiography) is more cost effective (cost less) than the current standards of care treatments. To determine if patients who present to the emergency room w/low to moderate probability of having an ACS (Acute Coronary Syndrome) prefer CCTA (coronary computed tomography angiography)-based care compared to standard algorithm based care.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chest Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
43 (Actual)

8. Arms, Groups, and Interventions

Arm Title
chest pain
Arm Type
Experimental
Arm Description
CCTA (Coronary computed tomography angiography)
Intervention Type
Procedure
Intervention Name(s)
CCTA (coronary computed tomography angiography)
Intervention Description
A CCTA (coronary computed tomography angiography) scan is a CT scan of the blood vessels of the heart. This CCTA (Coronary Computed Tomography Angiography)will be performed and a contrast medication will be injected through an IV line to help make the CT pictures more clear. Medication may or may not be given to control your heart rate during the scan. After the scan is completed it will be read. Your emergency room physician will use the CT results to determine your treatment.
Intervention Type
Other
Intervention Name(s)
Control section
Intervention Description
Normal emergency room treatment for symptoms of chest pain.
Primary Outcome Measure Information:
Title
To assess the usefulness of CCTA (coronary computed tomography angiography)in the emergency room setting to diagnose/predict the outcome of patients w/chest pain who have low to moderate risk of heart disease.
Time Frame
one year
Secondary Outcome Measure Information:
Title
To determine if the use of CCTA (coronary computed tomography angiography)is more cost effective than the current standard of care treatments being used.
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 25 years of age or older Experiencing chest pain Exclusion Criteria: Pregnant At high risk for ACS (Acute Coronary Syndrome)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suzanne Chong, MD
Organizational Affiliation
University of Michigan Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan Hospital
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States

12. IPD Sharing Statement

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Coronary Computed Tomography (CT) Angiography Versus Standard Therapy in the Emergency Room

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