NCT01750125

Brief Summary

The investigators hypothesize that performance of fast-Fourier transformation on the raw Doppler signals obtained from ascending aortic blood flow will recreate the pulse wave Doppler trace visualized on modern echocardiography machines, and that this will allow for the measurement and recording of vascular flow waveforms

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2012

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

December 12, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 17, 2012

Completed
15 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

May 1, 2014

Status Verified

April 1, 2014

Enrollment Period

1 month

First QC Date

December 12, 2012

Last Update Submit

April 30, 2014

Conditions

Keywords

Doppler

Outcome Measures

Primary Outcomes (1)

  • Comparison between estimated arterial flow waveform and pulse wave Doppler trace

    Estimated arterial flow waveform using fast Fourier transformation (FFT) will be compared to the pulse wave Doppler trace from the device

    day of procedure

Study Arms (1)

Healthy subjects

In these health subjects we will measure ascending aortic blood flow with pulse wave Doppler and also record the raw audio of the Doppler signal

Device: measure ascending aortic blood flow with pulse wave Doppler

Interventions

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Healthy subjects 18-65

You may qualify if:

  • Healthy

You may not qualify if:

  • Cannot visualize ascending aorta with ultrasound

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

Study Design

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

Study Record Dates

First Submitted

December 12, 2012

First Posted

December 17, 2012

Study Start

December 1, 2012

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

May 1, 2014

Record last verified: 2014-04

Locations