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

November 22, 2017 updated by: Kelley Branch, University of Washington

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

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

102

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Washington
      • Seattle, Washington, United States, 98195
        • University of Washington Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Alll patients presenting to the University of Washington Medical Center Emergency Department with possible acute coronary syndrome

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Diagnostic accuracy of CT compared to standard of care evaluation
Time Frame: 3 months
3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Cost savings of CT-based evaluation compared to the standard of care evaluation
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Washington

Collaborators

GE Healthcare

Investigators

  • Principal Investigator: Kelley R Branch, MD, University of Washington
  • Principal Investigator: William P Shuman, MD, University of Washington

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2006

Primary Completion (ACTUAL)

July 1, 2009

Study Completion (ACTUAL)

September 1, 2009

Study Registration Dates

First Submitted

March 3, 2009

First Submitted That Met QC Criteria

March 3, 2009

First Posted (ESTIMATE)

March 4, 2009

Study Record Updates

Last Update Posted (ACTUAL)

November 27, 2017

Last Update Submitted That Met QC Criteria

November 22, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 27903-D
  • 05-6337-D 03

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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