Comparison of 3 Ultrasonic Techniques for Measuring the Systolic Pressure Index

NCT04440072 | Unknown

• 1 other identifier: 20-037
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Peripheral Arterial Disease; Atherosclerosis Obliterans; Atherosclerosis Right Leg; Atherosclerosis Left Leg

Keywords

ankle brachial index; color duplex ultrasound; pulsed doppler

Outcome Measures

Primary Outcomes (1)

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

  30 minutes

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Caen: lead

Study Sites (1)

CHU de Caen

Caen, France

RECRUITING

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Central Study Contacts

Direction de la recherche et de l'enseignement

CONTACT

2 31 06 57 81; drci-secretariat@chu-caen.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2020
• First Posted: June 19, 2020
• Study Start: July 17, 2020
• Primary Completion: June 22, 2021
• Study Completion: June 22, 2021
• Last Updated: July 20, 2020

Record last verified: 2020-07

Locations

FR (1)