Trial record 7 of 26 for:    Open Studies | "Aortic Aneurysm, Thoracic"

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2012 by Yale University.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Richard Andrew Taylor, Yale University
ClinicalTrials.gov Identifier:
NCT01671618
First received: August 20, 2012
Last updated: NA
Last verified: August 2012
History: No changes posted
  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

Resource links provided by NLM:


Further study details as provided by Yale University:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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)
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 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
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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01671618

Contacts
Contact: Richard A Taylor, MD 860-402-1276 richard.taylor@yale.edu

Locations
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   
Sponsors and Collaborators
Yale University
Investigators
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 August 21, 2014