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:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- University Hospital, Caen
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- Concordance on the IPS value measured with pulsed Doppler compared to gold standard
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
Study Sites (1)
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