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

This study has been completed.
Sponsor:
Collaborator:
GE Healthcare
Information provided by (Responsible Party):
Kelley Branch, University of Washington
ClinicalTrials.gov Identifier:
NCT00855231
First received: March 3, 2009
Last updated: September 9, 2011
Last verified: September 2011
  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 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 ]

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
Additional 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
Study First Received: March 3, 2009
Last Updated: September 9, 2011
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on August 21, 2014