Peripheral Artery DiseaseBIORNCT03305198
BIOlogical Response to Exercise : A Metabolomic Study in Peripheral Artery Disease (BIOR)
A study testing Capillary blood sampling from the earlobe in people with Peripheral Artery Disease, run by University Hospital, Angers at 1 site in France.
Trial summary
The measurement of the transcutaneous oxygen pressure during walking allows to estimate the importance of ischemia, bilaterally and segment of limb by segment of limb. The determination of the metabolic compounds concentration, with metabolomic approach, is emerging in physiology and exercise. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Artery Disease
- What is being tested?
- Capillary blood sampling from the earlobe
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteFrance
- Study dates
- 1 Oct 2017to 18 Mar 2019
- 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
- Age > 18 years old
- Patient able to walk on a treadmill
- Patient agrees to be involve in the protocol and sign the consent form
Who cannot join
- Patient not covered by the French health insurance
- Patient has a wash-out period for another clinical trial
- Patient with comorbidity as bleeding disorder or with a anticoagulant therapy
Trial locations and contacts
1 site in 1 country.
About this study
The measurement of the transcutaneous oxygen pressure during walking allows to estimate the importance of ischemia, bilaterally and segment of limb by segment of limb. The determination of the metabolic compounds concentration, with metabolomic approach, is emerging in physiology and exercise.
This pilot study focuses on the feasibility of the metabolomics analysis with micro method , by capillary drawing from earlobe sampling, for patients with peripheral artery disease (PAD)
Read the detailed description
Ankle brachial index is measured at rest for alml subjects. Blood sample (180-360 microliter) will be collected at rest transcutaneous oxygen pressure is measured at the chest, calves and buttocks and results will be expressed as the minimal value of the DROP index (Limb changes minus chest changes) Patients walk on treadmill (2MPH 10% slope) until exertional limb pain. Blood sample (180 microliter) will be collected again, at minute 3 of recovery from walking Correlation of each metobolite increase to the sum of DROP values wil be studied.
- Conditions
- Peripheral Artery Disease
- Being tested
- Capillary blood sampling from the earlobe
- 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.
Capillary blood sampling from the earlobeBiological
Sample at rest before the walking test Sample at rest 3 minutes after the end of the walking period
| Study group | Role | What they receive |
|---|---|---|
| Patients undergoing exercise oximetry | Experimental | Patients with PAD referred for treadmill testing and exercise oximetry will have a capillary blood sampling from the earlobe Receives: Biological: Capillary blood sampling from the earlobe |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chances in the metabolomic signature of arterial claudication by capillary blood sampling from the earlobe
Search a significant difference between biological markers before and after the test during a walk on a treadmill
Measured: Half an hour (includes the resting walking and recovery period of exercise)
Secondary outcomes (1)
Changes inthe correlation of observed metabolomic variations and the importance of ischemia evaluated by oximetry
Evaluate the coefficient of correlation between the changes of metabolomic pârameters and the sum of the observed DROPmin values of all studied subjects.
Measured: Half an hour (includes the resting walking and recovery period of exercise)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2017
- Study start1 Oct 2017
- Primary completion18 Mar 2019
- Study completion18 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Artery DiseaseStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Analysis of changes in metabolomic signature from rest to post exercise
- Masking
- None (open label)
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Pierre ABRAHAM, MD, Ph.D, Principal investigator, University Hospital in Angers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03305198
- Sponsor's protocol ID
- 2017-A01147-46
- Acronym
- BIOR
- Status last verified
- Mar 2019
- First submitted
- 28 Sep 2017
- Last updated
- 22 Mar 2019
- 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 22 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BIOlogical Response to Exercise : A Metabolomic Study in Peripheral Artery Disease (BIOR)
- ClinicalTrials.gov ID
- NCT03305198
- Acronym / sponsor ID
- BIOR / 2017-A01147-46
- Conditions
- Peripheral Artery Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 18 Mar 2019 (actual)
- Study completion
- 18 Mar 2019 (actual)
- First posted
- 9 Oct 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.
The measurement of the transcutaneous oxygen pressure during walking allows to estimate the importance of ischemia, bilaterally and segment of limb by segment of limb. The determination of the metabolic compounds concentration, with metabolomic approach, is emerging in physiology and exercise.
This pilot study focuses on the feasibility of the metabolomics analysis with micro method , by capillary drawing from earlobe sampling, for patients with peripheral artery disease (PAD)
Detailed description
Ankle brachial index is measured at rest for alml subjects. Blood sample (180-360 microliter) will be collected at rest transcutaneous oxygen pressure is measured at the chest, calves and buttocks and results will be expressed as the minimal value of the DROP index (Limb changes minus chest changes) Patients walk on treadmill (2MPH 10% slope) until exertional limb pain. Blood sample (180 microliter) will be collected again, at minute 3 of recovery from walking Correlation of each metobolite increase to the sum of DROP values wil be studied.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Analysis of changes in metabolomic signature from rest to post exercise
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing exercise oximetry | Experimental | Biological: Capillary blood sampling from the earlobePatients with PAD referred for treadmill testing and exercise oximetry will have a capillary blood sampling from the earlobe |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age > 18 years old
- Patient able to walk on a treadmill
- Patient agrees to be involve in the protocol and sign the consent form
Key exclusion criteria (3 listed)
- Patient not covered by the French health insurance
- Patient has a wash-out period for another clinical trial
- Patient with comorbidity as bleeding disorder or with a anticoagulant therapy
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 |
|---|---|---|
| Capillary blood sampling from the earlobeSample at rest before the walking test Sample at rest 3 minutes after the end of the walking period | Biological | Patients undergoing exercise oximetry |
Primary outcome
Chances in the metabolomic signature of arterial claudication by capillary blood sampling from the earlobe
Time frame: Half an hour (includes the resting walking and recovery period of exercise)
Search a significant difference between biological markers before and after the test during a walk on a treadmill
1 secondary outcome
Changes inthe correlation of observed metabolomic variations and the importance of ischemia evaluated by oximetry
Time frame: Half an hour (includes the resting walking and recovery period of exercise)
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 22 Mar 2019.
- 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.
Pierre ABRAHAM, MD, Ph.D principal investigator
University Hospital in 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 Capillary blood sampling from the earlobe in people with Peripheral Artery Disease, 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 3 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 22 Mar 2019. 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?
Chances in the metabolomic signature of arterial claudication by capillary blood sampling from the earlobe (time frame: Half an hour (includes the resting walking and recovery period of exercise)). 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 22 Mar 2019.