Point-of-Care Focused Cardiac Ultrasound in Assessing the Thoracic Aorta
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Purpose
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 aneursymal disease.
| Condition |
|---|
|
Aortic Aneurysm, Thoracic Aortic Dissection |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| 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 |
- Maximal diameter measurements of the proximal ascending aorta by CTA and FOCUS [ Time Frame: during emergency department visit (estimated average 3-6 hours) ] [ Designated as safety issue: No ]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 to Emergency Department Disposition [ Time Frame: estimated time frame 3-6 hours ] [ Designated as safety issue: No ]Time until an admission or discharge order is placed within the electronic medical record
- Number and percent probabilities of differential diagnosis [ Time Frame: (estimated time frame 0 -3 hrous) ] [ Designated as safety issue: No ]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 to diagnostic imaging [ Time Frame: estimated time frame 0-6 hours ] [ Designated as safety issue: No ]Time when diagnostic imaging is performed
| Estimated Enrollment: | 210 |
| Study Start Date: | July 2012 |
| Estimated Study Completion Date: | July 2013 |
| Estimated Primary Completion Date: | July 2013 (Final data collection date for primary outcome measure) |
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 echochardiography (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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
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.
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
Contacts and Locations| Contact: Richard A Taylor, MD | 860-402-1276 | richard.taylor@yale.edu |
| United States, Connecticut | |
| Yale New Haven Hospital | Recruiting |
| New Haven, Connecticut, United States, 06519 | |
| Contact: Richard A Taylor, MD 860-402-1276 richard.taylor@yale.edu | |
| Principal Investigator: | Richard A Taylor, MD | Yale University |
More Information
No publications provided
| Responsible Party: | Richard Andrew Taylor, Assistant Professor of Emergency Medicine, Yale University |
| ClinicalTrials.gov Identifier: | NCT01671618 History of Changes |
| Other Study ID Numbers: | 1202009791 |
| Study First Received: | August 20, 2012 |
| Last Updated: | August 20, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Yale University:
|
Aortic dissection Aortic dilation Aortic Aneurysm |
ultrasound point-of-care echocardiography |
Additional relevant MeSH terms:
|
Aneurysm Aortic Aneurysm Aortic Aneurysm, Thoracic |
Vascular Diseases Cardiovascular Diseases Aortic Diseases |
ClinicalTrials.gov processed this record on May 16, 2013