UnknownNot Applicable

Comparison of 3 Ultrasonic Techniques for Measuring the Systolic Pressure Index

France150 participantsStarted 2020-07-17

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: 30 minutes

Trial details

NCT IDNCT04440072

SponsorUniversity Hospital, Caen

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2021-06-22

Contact for this trial

Direction de la recherche et de l'enseignement

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

View on ClinicalTrials.gov More Peripheral Arterial Disease trials