Peripheral Arterial DiseaseABIPULSENCT04440072
Comparison of 3 Ultrasonic Techniques for Measuring the Systolic Pressure Index
An observational study of Peripheral Arterial Disease and Atherosclerosis Obliterans, run by University Hospital, Caen at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Arterial Disease, Atherosclerosis Obliterans, Atherosclerosis Right Leg
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- 17 Jul 2020to 22 Jun 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Direction de la recherche et de l'enseignement contact
About this study
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
- Medical subject headings
- Peripheral Arterial Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Concordance on the IPS value measured with pulsed Doppler compared to gold standard
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2020
- Study start17 Jul 2020
- Primary completion22 Jun 2021 (estimated)
- Study completion22 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04440072
- Sponsor's protocol ID
- 20-037
- Acronym
- ABIPULSE
- Status last verified
- Jul 2020
- First submitted
- 17 Jun 2020
- Last updated
- 20 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of 3 Ultrasonic Techniques for Measuring the Systolic Pressure Index
- ClinicalTrials.gov ID
- NCT04440072
- Acronym / sponsor ID
- ABIPULSE / 20-037
- Conditions
- Peripheral Arterial Disease, Atherosclerosis Obliterans, Atherosclerosis Right Leg, Atherosclerosis Left Leg
- Keywords
- ankle brachial index, color duplex ultrasound, pulsed doppler
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- 17 Jul 2020 (actual)
- Primary completion
- 22 Jun 2021 (estimated)
- Study completion
- 22 Jun 2021 (estimated)
- First posted
- 19 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Concordance on the IPS value measured with pulsed Doppler compared to gold standard
Time frame: 30 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Direction de la recherche et de l'enseignement contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peripheral Arterial Disease and Atherosclerosis Obliterans, run by University Hospital, Caen at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Direction de la recherche et de l'enseignement (2 31 06 57 81 ext. +33, drci-secretariat@chu-caen.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concordance on the IPS value measured with pulsed Doppler compared to gold standard (time frame: 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2020.