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Diagnostic Accuracy of Multislice CT Angiography for Acute Chest Pain (ACUTE CT)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00855231
First Posted: March 4, 2009
Last Update Posted: September 12, 2011
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.
Collaborator:
GE Healthcare
Information provided by (Responsible Party):
Kelley Branch, University of Washington
  Purpose
The ACUTE CT trial is designed to test whether the assessment of chest structures by high-resolution multislice computed tomography (CT) provides equivalent diagnostic accuracy for patient with acute chest pain or other potential cardiac symptoms as compared to a standard of care evaluation.

Condition
Chest Pain Acute Coronary Syndrome Pulmonary Embolism Aortic Dissection

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Diagnostic Accuracy of Multislice CT Angiography for Acute Chest Pain - Assessment of Chest Pain Utilizing a Triple Rule Out Evaluation With Computed Tomography (ACUTE CT) Trial

Resource links provided by NLM:


Further study details as provided by Kelley Branch, University of Washington:

Primary Outcome Measures:
  • Diagnostic accuracy of CT compared to standard of care evaluation [ Time Frame: 3 months ]

Secondary Outcome Measures:
  • Cost savings of CT-based evaluation compared to the standard of care evaluation [ Time Frame: 3 months ]

Enrollment: 102
Study Start Date: July 2006
Study Completion Date: September 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Detailed Description:
Adults at low to intermediate risk of acute coronary syndrome who present to the Emergency Department with symptoms suggestive of cardiac ischemia will undergo a blinded cardiac CT followed by a standard of care (SOC) strategy. Significant coronary artery disease on CT (coronary stenosis >50%) will be compared to an adjudicated diagnosis derived from clinical data and other diagnostic tests based on the SOC strategy. Costs for the SOC evaluation will be collected and compared to a CT-based evaluation. Patients will be followed for 3 years after enrollment to evaluate prognosis.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Alll patients presenting to the University of Washington Medical Center Emergency Department with possible acute coronary syndrome
Criteria

Inclusion Criteria:

  • Low to intermediate risk of angina with a TIMI ACS Risk Score ≤ 4
  • chest pain or other symptoms suggestive of ACS within 24 hours
  • male ≥30 years or female ≥45 years old
  • at least one cardiac risk factor
  • no obvious cause for symptoms.

Exclusion Criteria:

  • known CAD
  • ST segment elevation, new left bundle branch block or dynamic ECG changes
  • creatinine ≥1.8 g/dL
  • pregnant or lactating female
  • hemodynamic or respiratory instability
  • ongoing bronchospasm
  • known iodinated contrast allergy
  • atrial fibrillation or irregular heart rate
  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): NCT00855231


Locations
United States, Washington
University of Washington Medical Center
Seattle, Washington, United States, 98195
Sponsors and Collaborators
University of Washington
GE Healthcare
Investigators
Principal Investigator: Kelley R Branch, MD University of Washington
Principal Investigator: William P Shuman, MD University of Washington
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Kelley Branch, Assistant Professor, University of Washington
ClinicalTrials.gov Identifier: NCT00855231     History of Changes
Other Study ID Numbers: 27903-D
05-6337-D 03
First Submitted: March 3, 2009
First Posted: March 4, 2009
Last Update Posted: September 12, 2011
Last Verified: September 2011

Keywords provided by Kelley Branch, University of Washington:
Acute coronary syndrome
Coronary artery disease
cardiac imaging
computed tomography

Additional relevant MeSH terms:
Acute Coronary Syndrome
Embolism
Pulmonary Embolism
Chest Pain
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Embolism and Thrombosis
Lung Diseases
Respiratory Tract Diseases
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms