Full Text View
Tabular View
No Study Results Posted
Related Studies
Diagnostic Accuracy of Multislice CT Angiography for Acute Chest Pain (ACUTE CT)
This study is currently recruiting participants.
Verified by University of Washington, March 2009
First Received: March 3, 2009   No Changes Posted
Sponsors and Collaborators: University of Washington
GE Healthcare
Information provided by: University of Washington
ClinicalTrials.gov Identifier: NCT00855231
  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: Cohort, 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 University of Washington:

Primary Outcome Measures:
  • Diagnostic accuracy of CT compared to standard of care evaluation [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cost savings of CT-based evaluation compared to the standard of care evaluation [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Biospecimen Retention:   None Retained

Biospecimen Description:

Estimated Enrollment: 100
Study Start Date: July 2006
Estimated Study Completion Date: October 2009
Estimated 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

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00855231

Locations
United States, Washington
University of Washington Medical Center Recruiting
Seattle, Washington, United States, 98195
Contact: Janet May, MS     206-543-4127     jbonny@u.washington.edu    
Contact: Kelley R Branch, MD     206-598-2826     kbranch@u.washington.edu    
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

No publications provided

Responsible Party: University of Washington ( William Shuman, MD )
Study ID Numbers: 27903-D, 05-6337-D 03
Study First Received: March 3, 2009
Last Updated: March 3, 2009
ClinicalTrials.gov Identifier: NCT00855231     History of Changes
Health Authority: United States: Institutional Review Board

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

Study placed in the following topic categories:
Heart Diseases
Pulmonary Embolism
Myocardial Ischemia
Vascular Diseases
Pain
Ischemia
Thrombosis
Chest Pain
Coronary Disease
Signs and Symptoms
Embolism and Thrombosis
Respiratory Tract Diseases
Embolism
Lung Diseases
Acute Coronary Syndrome
Coronary Artery Disease

Additional relevant MeSH terms:
Heart Diseases
Pulmonary Embolism
Disease
Myocardial Ischemia
Vascular Diseases
Pain
Chest Pain
Signs and Symptoms
Embolism and Thrombosis
Pathologic Processes
Respiratory Tract Diseases
Embolism
Syndrome
Lung Diseases
Acute Coronary Syndrome
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 11, 2009