French Vascular PhysiciansAPP-Wave-PADNCT03827512
Arterial Doppler Waveforms Analysis in PAD
An observational study of French Vascular Physicians, run by Rennes University Hospital at 1 site in France.
Trial summary
The main objective is to evaluate the differences of terminology used when describing arterial doppler waveforms. To assess the impact of an educational process Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- French Vascular Physicians
- What is being tested?
- Doppler arterial waveforms analysis
- How many people
- 1,000 participants
- Where
- 1 siteFrance
- Study dates
- 1 Dec 2018to 31 Dec 2022
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Vascular physicians enrolled in the mailing list of French society of vascular medicine
Who may be able to join
- Vascular physicians enrolled in the mailing list of French society of vascular medicine
Who cannot join
- No exclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Professional Practices - Arterial Doppler Waveforms Analysis in PAD
The main objective is to evaluate the differences of terminology used when describing arterial doppler waveforms.
To assess the impact of an educational process
Read the detailed description
Peripheral artery disease (PAD) is a common pathology that affects more than 200 million people worldwide. The prevalence of this pathology is estimated in France at 11% in patients over 40 years old. The Doppler arterial waveforms analysis is an important element to assess the hemodynamic state of a patient and contributes to the diagnosis of the pathology. A number of classifications have been proposed but their use varies from one university to another. We hypothesize that there is a great heterogeneity in the description of the arterial Doppler flow analysis. In addition, a new classification (Saint-Bonnet) has recently been proposed and we will evaluate the effect of the use of this one. The main objective is to evaluate the differences of terminology used when describing arterial Doppler waveforms.
The secondary objectives are: to understand the variations observed and expected (initial, continuous training, place of exercise ...) and to study the effect of a new classification on the heterogeneity of responses.
- Conditions
- French Vascular Physicians
- Being tested
- Doppler arterial waveforms analysis
- Keywords
- Vascular physicians, Peripheral artery disease, classification, doppler waveforms, Saint-Bonnet
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Doppler arterial waveforms analysisOther
terminology used when describing arterial Doppler waveforms
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences of terminology
Number of different terminologies used by the vascular physicians to describe the arterial flows
Measured: through study completion, an average of 1 year
Secondary outcomes (2)
Effect of a new classification on the heterogeneity of terminology used
Comparison of the number of terminology used without classification and the number of terminology used with a classification (Saint-Bonnet)
Measured: through study completion, an average of 1 year
Variations of description of the arterial Doppler waveforms
Significant difference in terms of heterogeneity by region or place of formation
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2019
- Study start1 Dec 2018
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for French Vascular PhysiciansStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- French Society of Vascular Medicine
- Responsible party
- Sponsor
- Investigators
- Guillaume MAHE, MD PHD, Principal investigator, Rennes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03827512
- Sponsor's protocol ID
- 35RC18_30019_APP-Wave-PAD
- Acronym
- APP-Wave-PAD
- Status last verified
- Jul 2019
- First submitted
- 30 Jan 2019
- Last updated
- 18 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Professional Practices - Arterial Doppler Waveforms Analysis in PAD
- ClinicalTrials.gov ID
- NCT03827512
- Acronym / sponsor ID
- APP-Wave-PAD / 35RC18_30019_APP-Wave-PAD
- Conditions
- French Vascular Physicians
- Keywords
- Vascular physicians, Peripheral artery disease, classification, doppler waveforms, Saint-Bonnet
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Collaborators
- French Society of Vascular Medicine
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 1 Feb 2019 (actual)
- 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 main objective is to evaluate the differences of terminology used when describing arterial doppler waveforms.
To assess the impact of an educational process
Detailed description
Peripheral artery disease (PAD) is a common pathology that affects more than 200 million people worldwide. The prevalence of this pathology is estimated in France at 11% in patients over 40 years old. The Doppler arterial waveforms analysis is an important element to assess the hemodynamic state of a patient and contributes to the diagnosis of the pathology. A number of classifications have been proposed but their use varies from one university to another. We hypothesize that there is a great heterogeneity in the description of the arterial Doppler flow analysis. In addition, a new classification (Saint-Bonnet) has recently been proposed and we will evaluate the effect of the use of this one. The main objective is to evaluate the differences of terminology used when describing arterial Doppler waveforms.
The secondary objectives are: to understand the variations observed and expected (initial, continuous training, place of exercise ...) and to study the effect of a new classification on the heterogeneity of responses.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Vascular physicians enrolled in the mailing list of French society of vascular medicine
Key inclusion criteria (1 listed)
- Vascular physicians enrolled in the mailing list of French society of vascular medicine
Key exclusion criteria (1 listed)
- No exclusion criteria
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 |
|---|---|---|
| Doppler arterial waveforms analysisterminology used when describing arterial Doppler waveforms | Other | – |
Primary outcome
Differences of terminology
Time frame: through study completion, an average of 1 year
Number of different terminologies used by the vascular physicians to describe the arterial flows
2 secondary outcomes
Effect of a new classification on the heterogeneity of terminology used
Time frame: through study completion, an average of 1 year
Variations of description of the arterial Doppler waveforms
Time frame: through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2019.
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.
Guillaume MAHE, MD PHD principal investigator
Rennes University Hospital
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 French Vascular Physicians, run by Rennes University Hospital at 1 site in France.
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 1 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: status not confirmed, as of the sponsor's last update on 18 Jul 2019. 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 France. 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?
Results are not available in the source record.
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?
Differences of terminology (time frame: through study completion, an average of 1 year). 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 18 Jul 2019.