Focus is on Healthy SubjectsNCT01750125
Validation of Pulse Wave Doppler Demodulation Algorithm for the Continuous, Non-invasive Measurement of Blood Flow Velocity
An observational study of Focus is on Healthy Subjects, run by University of Virginia at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Focus is on Healthy Subjects
- What is being tested?
- measure ascending aortic blood flow with pulse wave Doppler
- Type of treatment
- Medical device
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2012to Jan 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy subjects 18-65
Who may be able to join
- 18-65
- Healthy
Who cannot join
- Cannot visualize ascending aorta with ultrasound
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Virginia
Charlottesville, Virginia, 22908
About this study
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
Read the detailed description
Currently there is no commercially available mechanism for the measurement of blood flow velocity waveforms non-invasively. Blood flow velocity waveforms require the use of invasive catheters, thus precluding clinical use. Such information would allow the researcher / practitioner the ability to continuously measure blood flow, pulse pressure, and the pulsatility index of any vascular structure accessible by ultrasound with minimal additional risk to the subject / patient. This data, when combined with arterial blood pressure data, could also be used to measure peripheral pressure volume loops as well as aortic vascular impedance, both of which cannot be currently measured in vivo.
The ability to measure blood flow velocity waveforms at high temporal resolution would provide clinicians with new tools for hemodynamic optimization (both a novel means of estimating myocardial oxygen consumption [pressure volume area] as well as afterload [aortic vascular impedance]) and researchers with the ability to conduct hemodynamic experiments that were not previously possible. This work will serve as the foundation for several other related projects which depend on the ability to continuously record blood flow velocity waveforms.
- Conditions
- Focus is on Healthy Subjects
- Being tested
- measure ascending aortic blood flow with pulse wave Doppler
- Keywords
- Doppler
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
measure ascending aortic blood flow with pulse wave DopplerDevice
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: measure ascending aortic blood flow with pulse wave Doppler |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: day of procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2012 (estimated)
- Study startDec 2012
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Focus is on Healthy SubjectsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01750125
- Sponsor's protocol ID
- 16305
- Status last verified
- Apr 2014
- First submitted
- 12 Dec 2012
- Last updated
- 1 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Pulse Wave Doppler Demodulation Algorithm for the Continuous, Non-invasive Measurement of Blood Flow Velocity
- ClinicalTrials.gov ID
- NCT01750125
- Acronym / sponsor ID
- 16305
- Conditions
- Focus is on Healthy Subjects
- Keywords
- Doppler
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 17 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Currently there is no commercially available mechanism for the measurement of blood flow velocity waveforms non-invasively. Blood flow velocity waveforms require the use of invasive catheters, thus precluding clinical use. Such information would allow the researcher / practitioner the ability to continuously measure blood flow, pulse pressure, and the pulsatility index of any vascular structure accessible by ultrasound with minimal additional risk to the subject / patient. This data, when combined with arterial blood pressure data, could also be used to measure peripheral pressure volume loops as well as aortic vascular impedance, both of which cannot be currently measured in vivo.
The ability to measure blood flow velocity waveforms at high temporal resolution would provide clinicians with new tools for hemodynamic optimization (both a novel means of estimating myocardial oxygen consumption [pressure volume area] as well as afterload [aortic vascular impedance]) and researchers with the ability to conduct hemodynamic experiments that were not previously possible. This work will serve as the foundation for several other related projects which depend on the ability to continuously record blood flow velocity waveforms.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy subjects | – | Device: measure ascending aortic blood flow with pulse wave DopplerIn these health subjects we will measure ascending aortic blood flow with pulse wave Doppler and also record the raw audio of the Doppler signal |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy subjects 18-65
Key inclusion criteria (2 listed)
- 18-65
- Healthy
Key exclusion criteria (1 listed)
- Cannot visualize ascending aorta with ultrasound
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| measure ascending aortic blood flow with pulse wave Doppler | Device | Healthy subjects |
Primary outcome
Comparison between estimated arterial flow waveform and pulse wave Doppler trace
Time frame: day of procedure
Estimated arterial flow waveform using fast Fourier transformation (FFT) will be compared to the pulse wave Doppler trace from the device
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Focus is on Healthy Subjects, run by University of Virginia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison between estimated arterial flow waveform and pulse wave Doppler trace (time frame: day of procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2014.