NCT01671618

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
97

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2012

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 20, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 23, 2012

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

June 30, 2016

Status Verified

June 1, 2016

Enrollment Period

1 year

First QC Date

August 20, 2012

Last Update Submit

June 29, 2016

Conditions

Aortic Aneurysm, ThoracicAortic Dissection

Keywords

Aortic dissectionAortic dilationAortic Aneurysmultrasoundpoint-of-careechocardiography

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Time to Emergency Department Disposition

    estimated time frame 3-6 hours

  • Number and percent probabilities of differential diagnosis

    (estimated time frame 0 -3 hours)

  • Time to diagnostic imaging

    estimated time frame 0-6 hours

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yale New Haven Hospital

New Haven, Connecticut, 06519, United States

Location

MeSH Terms

Conditions

Aortic Aneurysm, ThoracicAortic DissectionAortic Aneurysm

Condition Hierarchy (Ancestors)

AneurysmVascular DiseasesCardiovascular DiseasesAortic DiseasesDissection, Blood VesselAcute Aortic Syndrome

Study Officials

  • Richard A Taylor, MD

    Yale University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 20, 2012

First Posted

August 23, 2012

Study Start

July 1, 2012

Primary Completion

July 1, 2013

Study Completion

July 1, 2013

Last Updated

June 30, 2016

Record last verified: 2016-06

Locations

US(1)