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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00846469
Recruitment Status : Completed
First Posted : February 18, 2009
Last Update Posted : December 5, 2012
Sponsor:
Information provided by (Responsible Party):

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.


Condition or disease Intervention/treatment
Chest Pain Procedure: CCTA (coronary computed tomography angiography) Other: Control section

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : July 2009
Primary Completion Date : June 2012
Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: chest pain
CCTA (Coronary computed tomography angiography)
Procedure: CCTA (coronary computed tomography angiography)
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.
Other: Control section
Normal emergency room treatment for symptoms of chest pain.


Outcome Measures

Primary Outcome Measures :
  1. 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 Measures :
  1. 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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 25 years of age or older
  • Experiencing chest pain

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00846469


Locations
United States, Michigan
University of Michigan Hospital
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
Investigators
Principal Investigator: Suzanne Chong, MD University of Michigan Hospital
More Information

Responsible Party: Suzanne Chong, MD, Principal Investigator, University of Michigan
ClinicalTrials.gov Identifier: NCT00846469     History of Changes
Other Study ID Numbers: HUM 0000 7282
First Posted: February 18, 2009    Key Record Dates
Last Update Posted: December 5, 2012
Last Verified: December 2012

Additional relevant MeSH terms:
Emergencies
Chest Pain
Disease Attributes
Pathologic Processes
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms