Protection of Arteritic Patients by Remote Preconditioning (PARADIS)

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.

Study Overview

• Status: Unknown
• Conditions: Obliterating Arteriopathy of the Lower Limbs
• Intervention / Treatment: Procedure: Control; Procedure: Remote ischemic preconditioning

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 Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Angers, France, 49000
    • Recruiting
    • Service de Médecine du Sport, CHU d'Angers
    • Contact: Pierre ABRAHAM, Professor; Phone Number: +33241.356.689; Email: PiAbraham@chu-angers.fr
    • Principal Investigator: Sylvain GRALL, Doctor
    • Sub-Investigator: Pierre ABRAHAM, Professor
    • Sub-Investigator: Antoine BRUNEAU, Doctor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Control	Procedure: Control; 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.
Active Comparator: Remote preconditioning	Procedure: Remote ischemic preconditioning; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Walking distance during the calibrated treadmill test	1 week

Secondary Outcome Measures

Outcome Measure	Time Frame
Tissue oxygenation measure by Near Infra-Red Spectroscopy during the test	1 week
TCPO2 half-rise time measure after the test	1 week
Measure of the deepness of TCPO2 drop	1 week
Heart rate measured 1 min and 2 min after test stop/ resting heart rate before test	1 week
Oxygen consumption analyse during the effort (VO2)	1 week
Lactate blood level at the end of the test	1 week

Collaborators and Investigators

• Sponsor: University Hospital, Angers
• Investigators: Study Director: Fabrice PRUNIER, Professor, University Hospital, Angers; Principal Investigator: Sylvain GRALL, Doctor, University Hospital, Angers

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (Anticipated): December 1, 2013
• Study Completion (Anticipated): December 1, 2013

Study Registration Dates

• First Submitted: October 17, 2013
• First Submitted That Met QC Criteria: October 23, 2013
• First Posted (Estimate): October 29, 2013

Study Record Updates

• Last Update Posted (Estimate): October 29, 2013
• Last Update Submitted That Met QC Criteria: October 23, 2013
• Last Verified: October 1, 2013

More Information

Terms related to this study

• Keywords: Remote ischemic preconditioning; Obliterating Arteriopathy of the Lower Limbs
• Other Study ID Numbers: AOI 2012-07

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No