Obliterating Arteriopathy of the Lower LimbsPARADISNCT01971879
Protection of Arteritic Patients by Remote Preconditioning
A study testing Remote ischemic preconditioning in people with Obliterating Arteriopathy of the Lower Limbs, run by University Hospital, Angers at 1 site in France.
Trial summary
Prospective, monocentric, randomised, double-blind study with 20 patients enrolled to be explored twice through a Cross-over strategy to determine whether remote preconditioning improves arteritic patients' ability to walk. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obliterating Arteriopathy of the Lower Limbs
- What is being tested?
- Remote ischemic preconditioning
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2013to Dec 2013
- 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
- Positive treadmill test (maximum walking distance < 750m because of lower limbs muscular pain)
- Resting systolic pressure index < 0,9 (uni- or bilateral)
- Resting systolic blood pressure <200mmHg
- Written informed consent
- Affiliation to a Social Security scheme
Who cannot join
- Effort hypoxemia during the selection treadmill test
- Patient treated with metformin during the 7 days preceding the treadmill tests
- Person who is not affiliated to a Social Security scheme or benefiting from such a scheme
- Person in an exclusion period related to another biomedical study
- Patient refusal / patient not having provided written informed consent
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Service de Médecine du Sport, CHU d'Angers
Angers, 49000
Pierre ABRAHAM, Professor, +33241.356.689, PiAbraham@chu-angers.fr
Sylvain GRALL, Doctor
About this study
Prospective, monocentric, randomised, double-blind study with 20 patients enrolled to be explored twice through a Cross-over strategy to determine whether remote preconditioning improves arteritic patients' ability to walk.
Read the detailed description
Patients will be screened amongst arteritic patients who have undergone a positive treadmill test in Angers University Hospital, defined by a premature test stop caused by muscular pain associated to trans-cutaneous pressure of oxygen (TCPO2) drop.
After signing the informed consent, patients will take two treadmill tests in a week-span. According to randomization, patients will undergo the "remote preconditioning" procedure or the "control" procedure before the first treadmill test. The following week, in respect to a cross-over strategy patients will undergo the other procedure before the second treadmill test.
Only the study nurse will be advised of the procedure to do. Investigators will not be informed about the allocated procedure. Patients will not be informed about the procedure supposed to have a beneficial effect.
The treadmill test will be run according to a calibrated protocol. After a 2-minute stand-up resting period, the treadmill will progressively speed up to a 3.2km/h during one minute. This stage will be maintained with a 10% slope for 14 minutes. Then, the treadmill's slope and speed will increase progressively every minute according to a calibrated protocol. The test duration will be measured from the start of the walk to the patient's request to stop because of pain in the lower limbs.
TCPO2 will be measured before and during the test on the glutei and the legs. Tissue oxygenation on both lower limbs will be measured by Near Infra-Red Spectroscopy (NIRO-200NX system). Oxygen consumption will be analysed throughout the test.
A blood sample will be drawn just before the start of the test, that is 5 minutes after the end of the last cuff deflation. A second blood sample will be drawn 2 minutes after the patient's request to stop walking. These blood samples are composed of one 3ml tube to measure out blood lactate level, one 6ml ethylene diamine tetraacetic acid (EDTA) tube and a 5ml plain tube. These two last tubes will be centrifuged and subsampled to build up a bio-collection stored at the local Biological Resources Center.
- Being tested
- Remote ischemic preconditioning, Control
- Keywords
- Remote ischemic preconditioning, Obliterating Arteriopathy of the Lower Limbs
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote ischemic preconditioningProcedure or surgery
A blood pressure cuff is placed on one arm and is inflated to 200mmHg during 5 minutes. During the following 5 minutes, the cuff is inflated at the same pressure on the contralateral arm. This sequence is repeated 3 times, that is to say 3 sequences of cuff inflation for 5 minutes on each arm followed by 5 minutes without inflation.
The treadmill test starts 5 minutes after the end of the last deflation of the cuff.
ControlProcedure or surgery
A blood pressure cuff is placed on one arm and is inflated to 10mmHg during 5 minutes. During the following 5 minutes, the cuff is inflated at the same pressure on the contralateral arm. This sequence is repeated 3 times, that is to say 3 sequences of cuff inflation for 5 minutes on each arm followed by 5 minutes without inflation.
The treadmill test starts 5 minutes after the end of the last deflation of the cuff.
| Study group | Role | What they receive |
|---|---|---|
| Control | Sham comparator | Not described Receives: Procedure: Control |
| Remote preconditioning | Active comparator | Not described Receives: Procedure: Remote ischemic preconditioning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Walking distance during the calibrated treadmill test
Measured: 1 week
Secondary outcomes (6)
Tissue oxygenation measure by Near Infra-Red Spectroscopy during the test
Measured: 1 week
TCPO2 half-rise time measure after the test
Measured: 1 week
Measure of the deepness of TCPO2 drop
Measured: 1 week
Heart rate measured 1 min and 2 min after test stop/ resting heart rate before test
Measured: 1 week
Oxygen consumption analyse during the effort (VO2)
Measured: 1 week
Lactate blood level at the end of the test
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2013 (estimated)
- Study startOct 2013
- Primary completionDec 2013 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obliterating Arteriopathy of the Lower LimbsStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Fabrice PRUNIER, Professor, Study director, University Hospital, AngersSylvain GRALL, Doctor, Principal investigator, University Hospital, Angers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01971879
- Sponsor's protocol ID
- AOI 2012-07
- Acronym
- PARADIS
- Status last verified
- Oct 2013
- First submitted
- 17 Oct 2013
- Last updated
- 29 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protection of Arteritic Patients by Remote Preconditioning
- ClinicalTrials.gov ID
- NCT01971879
- Acronym / sponsor ID
- PARADIS / AOI 2012-07
- Keywords
- Remote ischemic preconditioning, Obliterating Arteriopathy of the Lower Limbs
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- Oct 2013
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 29 Oct 2013 (estimated)
- 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.
Prospective, monocentric, randomised, double-blind study with 20 patients enrolled to be explored twice through a Cross-over strategy to determine whether remote preconditioning improves arteritic patients' ability to walk.
Detailed description
Patients will be screened amongst arteritic patients who have undergone a positive treadmill test in Angers University Hospital, defined by a premature test stop caused by muscular pain associated to trans-cutaneous pressure of oxygen (TCPO2) drop.
After signing the informed consent, patients will take two treadmill tests in a week-span. According to randomization, patients will undergo the "remote preconditioning" procedure or the "control" procedure before the first treadmill test. The following week, in respect to a cross-over strategy patients will undergo the other procedure before the second treadmill test.
Only the study nurse will be advised of the procedure to do. Investigators will not be informed about the allocated procedure. Patients will not be informed about the procedure supposed to have a beneficial effect.
The treadmill test will be run according to a calibrated protocol. After a 2-minute stand-up resting period, the treadmill will progressively speed up to a 3.2km/h during one minute. This stage will be maintained with a 10% slope for 14 minutes. Then, the treadmill's slope and speed will increase progressively every minute according to a calibrated protocol. The test duration will be measured from the start of the walk to the patient's request to stop because of pain in the lower limbs.
TCPO2 will be measured before and during the test on the glutei and the legs. Tissue oxygenation on both lower limbs will be measured by Near Infra-Red Spectroscopy (NIRO-200NX system). Oxygen consumption will be analysed throughout the test.
A blood sample will be drawn just before the start of the test, that is 5 minutes after the end of the last cuff deflation. A second blood sample will be drawn 2 minutes after the patient's request to stop walking. These blood samples are composed of one 3ml tube to measure out blood lactate level, one 6ml ethylene diamine tetraacetic acid (EDTA) tube and a 5ml plain tube. These two last tubes will be centrifuged and subsampled to build up a bio-collection stored at the local Biological Resources Center.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Sham comparator | Procedure: Control |
| Remote preconditioning | Active comparator | Procedure: Remote ischemic preconditioning |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Positive treadmill test (maximum walking distance < 750m because of lower limbs muscular pain)
- Resting systolic pressure index < 0,9 (uni- or bilateral)
- Resting systolic blood pressure <200mmHg
- Written informed consent
- Affiliation to a Social Security scheme
Key exclusion criteria (5 listed)
- Effort hypoxemia during the selection treadmill test
- Patient treated with metformin during the 7 days preceding the treadmill tests
- Person who is not affiliated to a Social Security scheme or benefiting from such a scheme
- Person in an exclusion period related to another biomedical study
- Patient refusal / patient not having provided written informed consent
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 |
|---|---|---|
| Remote ischemic preconditioningA blood pressure cuff is placed on one arm and is inflated to 200mmHg during 5 minutes. During the following 5 minutes, the cuff is inflated at the same pressure on the contralateral arm. This sequence is repeated 3 times, that is to say 3 sequences of cuff inflation for 5 minutes on each arm followed by 5 minutes without inflation. The treadmill test starts 5 minutes after the end of the last deflation of the cuff. | Procedure or surgery | Remote preconditioning |
| ControlA blood pressure cuff is placed on one arm and is inflated to 10mmHg during 5 minutes. During the following 5 minutes, the cuff is inflated at the same pressure on the contralateral arm. This sequence is repeated 3 times, that is to say 3 sequences of cuff inflation for 5 minutes on each arm followed by 5 minutes without inflation. The treadmill test starts 5 minutes after the end of the last deflation of the cuff. | Procedure or surgery | Control |
Primary outcome
Walking distance during the calibrated treadmill test
Time frame: 1 week
6 secondary outcomes
Tissue oxygenation measure by Near Infra-Red Spectroscopy during the test
Time frame: 1 week
TCPO2 half-rise time measure after the test
Time frame: 1 week
Measure of the deepness of TCPO2 drop
Time frame: 1 week
Heart rate measured 1 min and 2 min after test stop/ resting heart rate before test
Time frame: 1 week
Oxygen consumption analyse during the effort (VO2)
Time frame: 1 week
Lactate blood level at the end of the test
Time frame: 1 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2013.
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.
Fabrice PRUNIER, Professor study director
University Hospital, Angers
Sylvain GRALL, Doctor principal investigator
University Hospital, 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 Remote ischemic preconditioning in people with Obliterating Arteriopathy of the Lower Limbs, 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 5 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 29 Oct 2013. 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. Some participants in this study may receive a placebo. 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 Fabrice PRUNIER, Professor (+33241.355.147, faprunier@chu-angers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Walking distance during the calibrated treadmill test (time frame: 1 week). 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 29 Oct 2013.