Point-of-Care Focused Cardiac Ultrasound in Assessing the Thoracic Aorta

A Prospective Study on Point-of-Care Focused Cardiac Ultrasound in Assessing for Thoracic Aortic Dimensions, Dilation, and Aneurysm in Correlation With CT Angiogram in Suspected Cases of Pathology

The purpose of this prospective study is to compare point-of-care focused cardiac ultrasound (FOCUS) to thoracic computed tomographic angiography (CTA) in the measurement of ascending aortic dimensions. We hypothesize that FOCUS will demonstrate good agreement with CTA in the measurement of ascending aortic dimensions and accurately detect dilation and aneurysmal disease.

Study Overview

• Status: Completed
• Conditions: Aortic Dissection; Aortic Aneurysm, Thoracic

Detailed Description

Nonspecific chest pain is frequently encountered in the emergency department. Accounting for over 13,000 deaths annually, aortic aneurysmal disease is a potential cause of chest pain.There are multiple diagnostic imaging modalities in practice to interrogate the thoracic aorta, with the most common being computed tomographic angiography (CTA), trans-thoracic echocardiography (TTE) and trans-esophageal echocardiography (TEE), each with its own advantages and limitations. In the ED setting, point-of-care (POC) focused cardiac ultrasound (FOCUS) is increasingly being used as an adjunct to the emergency physician's (EP) workup of undifferentiated chest pain. Based on prior retrospective data FOCUS and CTA appear to have good agreement. This studies aims to confirm these findings through prospective evaluation

Specific Aims

Aim 1: To prospectively compare Point of Care (POC) Focused Cardiac Ultrasound (FOCUS) to thoracic computed tomographic angiography (CTA) in the measurement of ascending aortic dimensions.

Maximal diameter measurements of the ascending thoracic aorta by FOCUS will be compared to CTA. Bland Altman plots with 95% limits of agreement will be used to determine clinical and statistical significance.

Hypothesis: 95% limits of agreement between FOCUS and CTA will be within +/- 5 mm.

Aim 2: To determine the diagnostic accuracy of Point-of-Care Focused Cardiac Ultrasound for the detection of thoracic aortic dilation and aneurysm with computed tomographic angiography as the reference standard

Sensitivity, Specificity and Accuracy of FOCUS will be computed with CTA as the reference standard.

• Study Type: Observational
• Enrollment (Actual): 97

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06519
      • Yale New Haven Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients 18 years of age or older presenting to an urban, academic, and level I emergency department with estimated volume of approximately 90,000 patients per year.

Description

Inclusion Criteria:

• All patients aged 18 years and older presenting to the ED for whom a thoracic CTA has been ordered.

Exclusion Criteria:

• Refusal of verbal consent for ultrasound.
• Inability to obtain informed written consent for data collection from either the patient or the patients decision-making surrogate

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximal diameter measurements of the proximal ascending aorta by CTA and FOCUS	Maximal diameter measurements of the ascending thoracic aorta by FOCUS will be compared to CTA. Bland Altman plots with 95% limits of agreement will be used to determine clinical and statistical significance.	during emergency department visit (estimated average 3-6 hours)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Emergency Department Disposition	Time until an admission or discharge order is placed within the electronic medical record	estimated time frame 3-6 hours
Number and percent probabilities of differential diagnosis	Number and percent probabilities of differential diagnosis will be obtained before and after ultrasound to calculate the informational content provided by the ultrasound and perform additional uncertainty analyses	(estimated time frame 0 -3 hours)
Time to diagnostic imaging	Time when diagnostic imaging is performed	estimated time frame 0-6 hours

Collaborators and Investigators

• Sponsor: Yale University
• Investigators: Principal Investigator: Richard A Taylor, MD, Yale University

Study record dates

Study Major Dates

• Study Start: July 1, 2012
• Primary Completion (Actual): July 1, 2013
• Study Completion (Actual): July 1, 2013

Study Registration Dates

• First Submitted: August 20, 2012
• First Submitted That Met QC Criteria: August 20, 2012
• First Posted (Estimate): August 23, 2012

Study Record Updates

• Last Update Posted (Estimate): June 30, 2016
• Last Update Submitted That Met QC Criteria: June 29, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Keywords: ultrasound; echocardiography; Aortic Aneurysm; Aortic dissection; point-of-care; Aortic dilation
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Aortic Diseases; Aneurysm; Aneurysm, Dissecting; Aortic Aneurysm; Aortic Aneurysm, Thoracic
• Other Study ID Numbers: 1202009791