Clinical Trials Logo

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT03827512
Other study ID # 35RC18_30019_APP-Wave-PAD
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date December 1, 2018
Est. completion date December 31, 2022

Study information

Verified date July 2019
Source Rennes University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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


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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 1000
Est. completion date December 31, 2022
Est. primary completion date December 31, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

- No exclusion criteria

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Doppler arterial waveforms analysis
terminology used when describing arterial Doppler waveforms

Locations

Country Name City State
France Centre Hospitalier Universitaire de Rennes Rennes

Sponsors (2)

Lead Sponsor Collaborator
Rennes University Hospital French Society of Vascular Medicine

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Differences of terminology Number of different terminologies used by the vascular physicians to describe the arterial flows through study completion, an average of 1 year
Secondary 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) through study completion, an average of 1 year
Secondary Variations of description of the arterial Doppler waveforms Significant difference in terms of heterogeneity by region or place of formation through study completion, an average of 1 year