Artery Disease, PeripheralFirst-SEDANNCT03362710
Simplified and Easy Detection of Arterial Disease in Nursing Homes
A study testing simplified tools in people with Artery Disease, Peripheral, run by University Hospital, Angers at 1 site in France.
Trial summary
Peripheral artery disease (PAD) affects mainly elderly patients. The ankle brachial index (ABI) and ultrasound imaging are the standard diagnostic tools in PAD diagnostic and severity estimation. Measurements are generally performed by a vascular physician. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Artery Disease, Peripheral
- What is being tested?
- simplified tools
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 225 participants
- Where
- 1 siteFrance
- Study dates
- 9 Apr 2018to 30 Mar 2022
- Phase
- Interventional
- 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
Who may be able to join
- Patients referred for arterial assessment of the lower limbs as part of a screening or follow-up of PAD
- Patients without contraindications for all non-invasive measures
- Age superior to 18 years
- Affiliated patients of a social security scheme
- Patients who have signed informed consent.
Who cannot join
- Patients protected by law
- Patients unable to understand the objectives or instructions of the study
- Patients in an exclusion period relative to another biomedical study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation du Risque Vasculaire Par Mesures Non Invasives en Soins Primaires.
Peripheral artery disease (PAD) affects mainly elderly patients. The ankle brachial index (ABI) and ultrasound imaging are the standard diagnostic tools in PAD diagnostic and severity estimation. Measurements are generally performed by a vascular physician. However, access to medical specialist is becoming increasingly difficult with long waiting times while the aging of the population increases, while most of these patients are seen by the general practitioner.
To date, there is a lot of data in the literature on the value of using various ambulatory devices in the diagnosis and severity estimation of PAD but studied one by one.
The investigators propose to compare the measurements made by a series of simple non-invasive ambulatory tools with the measurements performed by the vascular specialist. The investigators wish to demonstrate that a series of simple and economical tools, available to paramedical health professionals can diagnose PAD and evaluate ts severity the reducing the direct and indirect associated costs.
Read the detailed description
Patients referred for an arterial vascular investigations of the lower limbs will be included.
After signing the consent, all included patients will be assessed by the examination series, among which ABI measurement and an arterial Doppler ultrasound of the lower limbs +/- transcutaneous oxygen pressure recording in case of suspected critical limb ischemia. Following the visit patients will be classified as have or not PAD and in case of PAD classified for the severity of PAD on the basis of the investigation results.
Blinded to the results of the vascular laboratory test, a technician will:
Measure ABI with an automatic sphygmomanometer.
Examination series:
- Skin temperature on the back of the foot with infra-red thermometry
- Toe saturometry
- ABI with an automatic sphygmomanometry
- Skin Recoloration time at the foot
- Conditions
- Artery Disease, Peripheral
- Being tested
- simplified tools
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
simplified toolsDiagnostic test
- Skin temperature on the back of the foot with infra-red thermometry
- Toe saturometry
- ABI with an automatic sphygmomanometry
- Skin Recoloration time at the foot
| Study group | Role | What they receive |
|---|---|---|
| PAD patients | Experimental | Patients referred for an arterial doppler assessment of lower limbs will be included.
Intervention is a series of examination, followed by the measurement of the ABI and an arterial echo-doppler of the lower limbs +/- transcutaneous oxygen pressure measurements in case of suspected critical limb ischemia.
A technician will perform the evaluation with simplified tools blinded to the results of vascular specialised investigations Receives: Diagnostic Test: simplified tools |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance of non-invasive measurements
Performance of the score will be studied with the receiver operating characteristic (ROC) approach and multivariate analysis using echo-doppler and transcutaneous oxymetry results as references for PAD severity classification standard
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2017
- Study start9 Apr 2018
- Primary completion30 Mar 2022
- Study completion30 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Artery Disease, PeripheralStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 225 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Samir HENNI, MD,PhD, Principal investigator, UH Angers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03362710
- Sponsor's protocol ID
- 2017-A02635-48
- Acronym
- First-SEDAN
- Status last verified
- Aug 2020
- First submitted
- 29 Nov 2017
- Last updated
- 31 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation du Risque Vasculaire Par Mesures Non Invasives en Soins Primaires.
- ClinicalTrials.gov ID
- NCT03362710
- Acronym / sponsor ID
- First-SEDAN / 2017-A02635-48
- Conditions
- Artery Disease, Peripheral
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 225 participants (actual)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- 9 Apr 2018 (actual)
- Primary completion
- 30 Mar 2022 (actual)
- Study completion
- 30 Mar 2022 (actual)
- First posted
- 5 Dec 2017 (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.
Peripheral artery disease (PAD) affects mainly elderly patients. The ankle brachial index (ABI) and ultrasound imaging are the standard diagnostic tools in PAD diagnostic and severity estimation. Measurements are generally performed by a vascular physician. However, access to medical specialist is becoming increasingly difficult with long waiting times while the aging of the population increases, while most of these patients are seen by the general practitioner.
To date, there is a lot of data in the literature on the value of using various ambulatory devices in the diagnosis and severity estimation of PAD but studied one by one.
The investigators propose to compare the measurements made by a series of simple non-invasive ambulatory tools with the measurements performed by the vascular specialist. The investigators wish to demonstrate that a series of simple and economical tools, available to paramedical health professionals can diagnose PAD and evaluate ts severity the reducing the direct and indirect associated costs.
Detailed description
Patients referred for an arterial vascular investigations of the lower limbs will be included.
After signing the consent, all included patients will be assessed by the examination series, among which ABI measurement and an arterial Doppler ultrasound of the lower limbs +/- transcutaneous oxygen pressure recording in case of suspected critical limb ischemia. Following the visit patients will be classified as have or not PAD and in case of PAD classified for the severity of PAD on the basis of the investigation results.
Blinded to the results of the vascular laboratory test, a technician will:
Measure ABI with an automatic sphygmomanometer.
Examination series:
- Skin temperature on the back of the foot with infra-red thermometry
- Toe saturometry
- ABI with an automatic sphygmomanometry
- Skin Recoloration time at the foot
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PAD patients | Experimental | Diagnostic Test: simplified toolsPatients referred for an arterial doppler assessment of lower limbs will be included. Intervention is a series of examination, followed by the measurement of the ABI and an arterial echo-doppler of the lower limbs +/- transcutaneous oxygen pressure measurements in case of suspected critical limb ischemia. A technician will perform the evaluation with simplified tools blinded to the results of vascular specialised investigations |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients referred for arterial assessment of the lower limbs as part of a screening or follow-up of PAD
- Patients without contraindications for all non-invasive measures
- Age superior to 18 years
- Affiliated patients of a social security scheme
- Patients who have signed informed consent.
Key exclusion criteria (3 listed)
- Patients protected by law
- Patients unable to understand the objectives or instructions of the study
- Patients in an exclusion period relative to another biomedical study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| simplified tools1. Skin temperature on the back of the foot with infra-red thermometry 2. Toe saturometry 3. ABI with an automatic sphygmomanometry 4. Skin Recoloration time at the foot | Diagnostic test | PAD patients |
Primary outcome
Performance of non-invasive measurements
Time frame: 1 hour
Performance of the score will be studied with the receiver operating characteristic (ROC) approach and multivariate analysis using echo-doppler and transcutaneous oxymetry results as references for PAD severity classification standard
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
- Individual participant dataSharing planned: No
Related trials for Artery Disease, Peripheral
Active, not recruiting
SUCCESS (SelUtion, Safety, effiCaCy, hEalth economicS and promS) PTA Study
Peripheral Artery Disease
RecruitingPhase 3
Reducing Adverse Vascular Outcomes With Factor XI Inhibition in Adult Participants With Peripheral Artery Disease
Peripheral Artery Disease (PAD)
Recruiting
The THOR IDE Study
Peripheral Artery Disease, Peripheral Artery Stenosis
Not yet recruiting
Daily Stretching to Improve Walking in Older Patients With Peripheral Artery Disease: The STRETCH PAD Study
Peripheral Artery Disease (PAD), Intermittent Claudication
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
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.
Samir HENNI, MD,PhD principal investigator
UH Angers
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing simplified tools in people with Artery Disease, Peripheral, run by University Hospital, Angers 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 5 inclusion and 3 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: finished, as of the sponsor's last update on 31 Mar 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Performance of non-invasive measurements (time frame: 1 hour). 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 31 Mar 2022.