Clinical trial NCT01971879: Protection of Arteritic Patients by Remote Preconditioning
Official title: Protection of Arteritic Patients by Remote Preconditioning
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obliterating Arteriopathy of the Lower Limbs
Keywords: Remote ischemic preconditioning
Obliterating Arteriopathy of the Lower Limbs
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2013-10-29
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Walking distance during the calibrated treadmill test
timeFrame: 1 week
Secondary outcomes:
measure: Tissue oxygenation measure by Near Infra-Red Spectroscopy during the test
timeFrame: 1 week
measure: TCPO2 half-rise time measure after the test
timeFrame: 1 week
measure: Measure of the deepness of TCPO2 drop
timeFrame: 1 week
measure: Heart rate measured 1 min and 2 min after test stop/ resting heart rate before test
timeFrame: 1 week
measure: Oxygen consumption analyse during the effort (VO2)
timeFrame: 1 week
measure: Lactate blood level at the end of the test
timeFrame: 1 week
Other outcomes:
Locations:
city: Angers
country: France
facility: Service de Médecine du Sport, CHU d'Angers
Study officials:
affiliation: University Hospital, Angers
name: Fabrice PRUNIER, Professor
role: STUDY_DIRECTOR
affiliation: University Hospital, Angers
name: Sylvain GRALL, Doctor
role: PRINCIPAL_INVESTIGATOR
References: