An observational study in Aortic Aneurysm, Thoracic and Aortic Dissection, sponsored by Yale University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-06-30.
Sponsored by Yale University · Observational
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.
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.
385 studies on the registry are indexed under Aortic Dissection; 117 are open to participants now.
This study's enrollment of 97 is below the median of 182 across 179 observational studies indexed under Aortic Dissection.
Browse Aortic Dissection studies →Yale University is the lead sponsor of 1,724 studies on the registry; 298 are open to participants now.
Of its 210 completed or terminated interventional studies of FDA-regulated products, 126 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
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.
Time frame: during emergency department visit (estimated average 3-6 hours)
Time to Emergency Department Disposition
Time until an admission or discharge order is placed within the electronic medical record
Time frame: 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
Time frame: (estimated time frame 0 -3 hours)
Time to diagnostic imaging
Time when diagnostic imaging is performed
Time frame: estimated time frame 0-6 hours
This study is completed, as verified in Jun 2016. You cannot join it, but the record below documents what was studied.
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