Clinical trial NCT01671618: Point-of-Care Focused Cardiac Ultrasound in Assessing the Thoracic Aorta
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aortic Aneurysm, Thoracic
Aortic Dissection
Keywords: Aortic dissection
Aortic dilation
Aortic Aneurysm
ultrasound
point-of-care
echocardiography
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2012-08-23
Enrollment: 97
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Maximal diameter measurements of the proximal ascending aorta by CTA and FOCUS
timeFrame: during emergency department visit (estimated average 3-6 hours)
Secondary outcomes:
measure: Time to Emergency Department Disposition
timeFrame: estimated time frame 3-6 hours
measure: Number and percent probabilities of differential diagnosis
timeFrame: (estimated time frame 0 -3 hours)
measure: Time to diagnostic imaging
timeFrame: estimated time frame 0-6 hours
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale New Haven Hospital
state: Connecticut
Study officials:
affiliation: Yale University
name: Richard A Taylor, MD
role: PRINCIPAL_INVESTIGATOR
References: