Comparison of 3 Ultrasonic Techniques for Measuring the Systolic Pressure Index (ABIPULSE)

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 Overview

• Status: Unknown
• Conditions: Peripheral Arterial Disease; Atherosclerosis Obliterans; Atherosclerosis Right Leg; Atherosclerosis Left Leg

• Study Type: Observational
• Enrollment (Anticipated): 150

Contacts and Locations

• Study Contact: Name: Direction de la recherche et de l'enseignement; Phone Number: +33 2 31 06 57 81; Email: drci-secretariat@chu-caen.fr

Study Locations

• France
  • Caen, France
    • Recruiting
    • CHU de Caen
    • Contact: Damien LANNEELE

Participation Criteria

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

Patient referred to the Vascular Medicine Department for a vascular examination with ABI measurement. In most cases, these patients present with symptoms suggestive of PAD, most often with vascular risk factors for atherosclerosis.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Concordance on the IPS value measured with pulsed Doppler compared to gold standard	30 minutes

Collaborators and Investigators

• Sponsor: University Hospital, Caen

Study record dates

Study Major Dates

• Study Start (Actual): July 17, 2020
• Primary Completion (Anticipated): June 22, 2021
• Study Completion (Anticipated): June 22, 2021

Study Registration Dates

• First Submitted: June 17, 2020
• First Submitted That Met QC Criteria: June 17, 2020
• First Posted (Actual): June 19, 2020

Study Record Updates

• Last Update Posted (Actual): July 20, 2020
• Last Update Submitted That Met QC Criteria: July 17, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: ankle brachial index; color duplex ultrasound; pulsed doppler
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Peripheral Arterial Disease; Peripheral Vascular Diseases; Atherosclerosis
• Other Study ID Numbers: 20-037

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No