Doppler Flow Classification of Saint-Bonnet (Saint-Bonnet)

March 15, 2018 updated by: Rennes University Hospital

Doppler Flow Classification of Saint-Bonnet : A Non Interventional Clinical Trial

Observational Study that evaluates the interest of Doppler waveforms classification in Peripheral Artery disease

Study Overview

Status

Unknown

Conditions

Detailed Description

Patients who have Doppler ultrasound scanning in clinical practice currently have a systematic record of Doppler flow on arterial axes of the aorta and right and left lower limbs. The investigators will analyze a posteriori Doppler flow of patients by classifying them using the 3 classifications. The patient will have no constraints related to this study since the recordings are currently performed in clinical routine.

Study Type

Observational

Enrollment (Anticipated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Amiens, France, 80000
        • Recruiting
        • CHU AMIENS
        • Contact:
          • SEVESTRE
      • Bordeaux, France
        • Recruiting
        • CHU de Bordeaux
        • Contact:
          • CONSTANS
      • Brest, France, 29000
      • Caen, France, 14000
        • Recruiting
        • CHU De Caen
        • Contact:
          • LANEELLE
      • Grenoble, France, 38000
        • Recruiting
        • CHU de Grenoble
        • Contact:
          • PERNOD
      • Limoges, France, 87100
        • Recruiting
        • CHU de Limoges
        • Contact:
          • LACROIX
      • Rennes, France, 35033
      • Saint-Étienne, France, 42100
        • Recruiting
        • Chu de Saint-Etienne
        • Contact:
          • HELLO CLAIRE
      • Toulouse, France, 31555
        • Recruiting
        • CHU de Toulouse
        • Contact:
          • BURA-RIVIERE
      • Vichy, France, 03200
        • Recruiting
        • CH de Vichy
        • Contact:
          • ABBADIE FABRICE

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients addressed in a vascular center for vascular ultrasound

Description

Inclusion Criteria:

  • Age greater than or equal to 18 years;
  • Social insured
  • Patients referred in the department for any arterial examination of the lower limbs.

Exclusion Criteria:

- Patient unfit to understand the instructions of the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Doppler flows
Time Frame: Baseline
The difference between the number of unclassified Doppler flows using the Saint-Bonnet classification and the number of unclassified flows using the Spronk et al. This comparison will be done using the Mc Nemar test.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rennes University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 2016

Primary Completion (Anticipated)

December 1, 2022

Study Completion (Anticipated)

December 1, 2022

Study Registration Dates

First Submitted

March 7, 2018

First Submitted That Met QC Criteria

March 7, 2018

First Posted (Actual)

March 14, 2018

Study Record Updates

Last Update Posted (Actual)

March 19, 2018

Last Update Submitted That Met QC Criteria

March 15, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 35RC18_3099_SaintBonnet

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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