## Protocol Section
### Identification Module
**NCT ID:** NCT01971879

**Acronym:** PARADIS

**Brief Title:** Protection of Arteritic Patients by Remote Preconditioning

**Official Title:** Protection of Arteritic Patients by Remote Preconditioning

#### Organization Study ID Info
**ID:** AOI 2012-07
#### Organization
**Class:** OTHER_GOV
**Full Name:** University Hospital, Angers
### Status Module
#### Completion Date
**Date:** 2013-12

**Type:** ESTIMATED

#### Expanded Access Info
**Last Known Status:** RECRUITING
#### Last Update Post Date
**Date:** 2013-10-29

**Type:** ESTIMATED

**Last Update Submit Date:** 2013-10-23

**Overall Status:** UNKNOWN

#### Primary Completion Date
**Date:** 2013-12

**Type:** ESTIMATED

#### Start Date
**Date:** 2013-10

**Status Verified Date:** 2013-10

#### Study First Post Date
**Date:** 2013-10-29
**Type:** ESTIMATED
**Study First Submit Date:** 2013-10-17
**Study First Submit QC Date:** 2013-10-23
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER_GOV

**Name:** University Hospital, Angers

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Obliterating Arteriopathy of the Lower Limbs

**Keywords:**

- Remote ischemic preconditioning

- Obliterating Arteriopathy of the Lower Limbs

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** CROSSOVER

##### Masking Info

**Masking:** DOUBLE

**Who Masked:**

- PARTICIPANT

- INVESTIGATOR

**Primary Purpose:** SUPPORTIVE_CARE

#### Enrollment Info

**Count:** 20

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Procedure: Control

**Label:** Control

**Type:** SHAM_COMPARATOR

#### Arm Group 2

**Intervention Names:**

- Procedure: Remote ischemic preconditioning

**Label:** Remote preconditioning

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Remote preconditioning

**Description:** 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.

**Name:** Remote ischemic preconditioning

**Type:** PROCEDURE

#### Intervention 2

**Arm Group Labels:**

- Control

**Description:** 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.

**Name:** Control

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

**Measure:** Walking distance during the calibrated treadmill test

**Time Frame:** 1 week

#### Secondary Outcomes

**Measure:** Tissue oxygenation measure by Near Infra-Red Spectroscopy during the test

**Time Frame:** 1 week

**Measure:** TCPO2 half-rise time measure after the test

**Time Frame:** 1 week

**Measure:** Measure of the deepness of TCPO2 drop

**Time Frame:** 1 week

**Measure:** Heart rate measured 1 min and 2 min after test stop/ resting heart rate before test

**Time Frame:** 1 week

**Measure:** Oxygen consumption analyse during the effort (VO2)

**Time Frame:** 1 week

**Measure:** Lactate blood level at the end of the test

**Time Frame:** 1 week

### Eligibility Module

**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

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** faprunier@chu-angers.fr

**Name:** Fabrice PRUNIER, Professor

**Phone:** +33241.355.147

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Angers

**Contacts:**

***Contact 1:***

- **Email:** PiAbraham@chu-angers.fr

- **Name:** Pierre ABRAHAM, Professor

- **Phone:** +33241.356.689

- **Role:** CONTACT

***Contact 2:***

- **Name:** Sylvain GRALL, Doctor

- **Role:** PRINCIPAL_INVESTIGATOR

***Contact 3:***

- **Name:** Pierre ABRAHAM, Professor

- **Role:** SUB_INVESTIGATOR

***Contact 4:***

- **Name:** Antoine BRUNEAU, Doctor

- **Role:** SUB_INVESTIGATOR

**Country:** France

**Facility:** Service de Médecine du Sport, CHU d'Angers

**Status:** RECRUITING

**Zip:** 49000

#### Overall Officials

**Official 1:**

**Affiliation:** University Hospital, Angers

**Name:** Fabrice PRUNIER, Professor

**Role:** STUDY_DIRECTOR

**Official 2:**

**Affiliation:** University Hospital, Angers

**Name:** Sylvain GRALL, Doctor

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M10543

- Name: Ischemia

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
