Diagnostic Accuracy of Multislice CT Angiography for Acute Chest Pain

Completed

• Conditions: Acute Coronary Syndrome; Chest Pain; Pulmonary Embolism; Aortic Dissection

• Registration Number: NCT00855231
• Lead Sponsor: University of Washington

Brief Summary

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.

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.

Study Timeline

• Study Start: 2006-07
• Study First Submitted: 2009-03-03
• Study First Submitted QC: 2009-03-03
• Study First Posted: 2009-03-04
• Primary Completion: 2009-07
• Study Completion: 2009-09
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-22
• Last Update Posted: 2017-11-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 102

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.

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Diagnostic accuracy of CT compared to standard of care evaluation	3 months

Secondary Outcome Measures

Name	Time	Method
Cost savings of CT-based evaluation compared to the standard of care evaluation	3 months

Trial Locations

Locations (1)

University of Washington Medical Center; 🇺🇸 Seattle, Washington, United States