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

This study is currently recruiting participants.
Verified August 2011 by University of Michigan
Sponsor:
Information provided by:
University of Michigan
ClinicalTrials.gov Identifier:
NCT00846469
First received: February 17, 2009
Last updated: August 30, 2011
Last verified: August 2011
History of Changes
  Purpose

The purpose of this study is to determine the usefulness of CCTA (Coronary CT 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 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 prefer CCTA-based care compared to standard algorithm based care.


Condition Intervention
Chest Pain
 Procedure: CCTA
Other: Control section

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • To assess the usefulness of CCTA 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To determine if the use of CCTA is more cost effective than the current standard of care treatments being used. [ Time Frame: one year ] [ Designated as safety issue: No ]

Estimated Enrollment: 400
Study Start Date: July 2009
Estimated Study Completion Date: August 2012
Estimated Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: chest pain
CCTA
 Procedure: CCTA
A CCTA scan is a CT scan of the blood vessels of the heart. This CCTA (CT Coronary 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.

  Eligibility

Ages Eligible for Study:   25 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00846469

Contacts
Contact: Suzanne Chong, MD 734-647-8628 suzchong@umich.edu
Contact: Ella Kazerooni, MD 734-936--4366 ellakaz@umich.edu

Locations
United States, Michigan
University of Michigan Hospital Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Suzanne Chong, MD         suzchong@umich.edu    
Principal Investigator: Suzanne Chong, MD            
Sponsors and Collaborators
University of Michigan
Investigators
Principal Investigator: Suzanne Chong, MD University of Michigan Hospital
  More Information

No publications provided

Responsible Party: Suzanne Chong MD, University of Michigan Hospital
ClinicalTrials.gov Identifier: NCT00846469     History of Changes
Other Study ID Numbers: HUM 0000 7282
Study First Received: February 17, 2009
Last Updated: August 30, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Chest Pain
Emergencies
Acute Coronary Syndrome
Pain
Signs and Symptoms
Disease Attributes
 Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Angina Pectoris
Vascular Diseases

ClinicalTrials.gov processed this record on September 26, 2012