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Clinical Trials/NCT04440072
NCT04440072UnknownNot Applicable

Comparison of 3 Ultrasonic Techniques for Measuring the Systolic Pressure Index

University Hospital, Caen1 site in 1 country150 target enrollmentStarted: July 17, 2020Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Enrollment
150
Locations
1
Primary Endpoint
Concordance on the IPS value measured with pulsed Doppler compared to gold standard
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

Continuous Doppler ankle brachial index (ABI) is the gold standard for screening and monitoring of peripheral arterial disease (PAD) but is no longer carried out in clinical practice.

The recommended measurement was gradually replaced by colour or pulsed Doppler without validation of these techniques.

The objective of our study is to compare these two techniques (color Doppler and pulsed Doppler in echodoppler) with respect to the gold standard (continuous Doppler) for ABI measurement.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Cross Sectional

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Patient referred to the Vascular Medicine Department of Caen University Hospital for a vascular examination with ABI measurement having been informed and not objecting to participation in the study and benefiting from a social protection system.

Exclusion Criteria

  • •Patient with arrhythmia
  • •Patient with trans-tibial or more proximal amputation
  • •Patient with extensive trophic disorder not allowing measurement
  • •Patient with subgonal bypass
  • •Known bilateral sub-clavian stenoses
  • •Patient deprived of liberty or under a measure of legal protection
  • •Interned patient for the treatment of a psychiatric or physical illness
  • •Patients who are legally incompetent, under the protection of justice, under guardianship or trusteeship.

Outcomes

Primary Outcomes

Concordance on the IPS value measured with pulsed Doppler compared to gold standard

Time Frame: 30 minutes

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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