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Arterial Doppler Waveforms Analysis in PAD (APP-Wave-PAD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03827512
Recruitment Status : Enrolling by invitation
First Posted : February 1, 2019
Last Update Posted : July 18, 2019
Sponsor:
Collaborator:
French Society of Vascular Medicine
Information provided by (Responsible Party):
Rennes University Hospital

Brief 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


Condition or disease Intervention/treatment
French Vascular Physicians Other: Doppler arterial waveforms analysis

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.

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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: Assessment of Professional Practices - Arterial Doppler Waveforms Analysis in PAD
Actual Study Start Date : December 1, 2018
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022

Intervention Details:
  • Other: Doppler arterial waveforms analysis
    terminology used when describing arterial Doppler waveforms


Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Effect of a new classification on the heterogeneity of terminology used [ Time Frame: through study completion, an average of 1 year ]
    Comparison of the number of terminology used without classification and the number of terminology used with a classification (Saint-Bonnet)

  2. Variations of description of the arterial Doppler waveforms [ Time Frame: through study completion, an average of 1 year ]
    Significant difference in terms of heterogeneity by region or place of formation



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Vascular physicians enrolled in the mailing list of French society of vascular medicine
Criteria

Inclusion Criteria:

  • Vascular physicians enrolled in the mailing list of French society of vascular medicine

Exclusion Criteria:

  • No exclusion criteria

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03827512


Locations
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France
Centre Hospitalier Universitaire de Rennes
Rennes, France, 35033
Sponsors and Collaborators
Rennes University Hospital
French Society of Vascular Medicine
Investigators
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Principal Investigator: Guillaume MAHE, MD PHD Rennes University Hospital
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Responsible Party: Rennes University Hospital
ClinicalTrials.gov Identifier: NCT03827512    
Other Study ID Numbers: 35RC18_30019_APP-Wave-PAD
First Posted: February 1, 2019    Key Record Dates
Last Update Posted: July 18, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Rennes University Hospital:
Vascular physicians
Peripheral artery disease
classification
doppler waveforms
Saint-Bonnet