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NCT04440072 Clinical Trial

Comparison of 3 Ultrasonic Techniques for Measuring the Systolic Pressure Index

Peripheral Arterial Disease Clinical Trial

— ABIPULSE  

Official title:
Comparison of 3 Ultrasonic Techniques for Measuring the Systolic Pressure Index

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04440072
Other study ID # 20-037
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date July 17, 2020
Est. completion date June 22, 2021

Study information
Verified date July 2020
Source University Hospital, Caen
Contact Direction de la recherche et de l'enseignement
Phone 2 31 06 57 81
Email drci-secretariat@chu-caen.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 150
Est. completion date June 22, 2021
Est. primary completion date June 22, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
France CHU de Caen Caen

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Caen

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Concordance on the IPS value measured with pulsed Doppler compared to gold standard 30 minutes
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