Peripheral Arterial Disease Clinical Trial
— ABIPULSEOfficial title:
Comparison of 3 Ultrasonic Techniques for Measuring the Systolic Pressure Index
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 |
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.
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. |
Country | Name | City | State |
---|---|---|---|
France | CHU de Caen | Caen |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Caen |
France,
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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