NCT01971879

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

October 17, 2013

Completed
12 days until next milestone

First Posted

Study publicly available on registry

October 29, 2013

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

October 29, 2013

Status Verified

October 1, 2013

Enrollment Period

2 months

First QC Date

October 17, 2013

Last Update Submit

October 23, 2013

Conditions

Obliterating Arteriopathy of the Lower Limbs

Keywords

Remote ischemic preconditioningObliterating Arteriopathy of the Lower Limbs

Outcome Measures

Primary Outcomes (1)

  • Walking distance during the calibrated treadmill test

    1 week

Secondary Outcomes (6)

  • 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

  • +1 more secondary outcomes

Study Arms (2)

Control

SHAM COMPARATOR
Procedure: Control

Remote preconditioning

ACTIVE COMPARATOR
Procedure: Remote ischemic preconditioning

Interventions

Remote ischemic preconditioningPROCEDURE

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.

Remote preconditioning
ControlPROCEDURE

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.

Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • Patient refusal / patient not having provided written informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service de Médecine du Sport, CHU d'Angers

Angers, 49000, France

RECRUITING

Study Officials

  • Fabrice PRUNIER, Professor

    University Hospital, Angers

    STUDY DIRECTOR

  • Sylvain GRALL, Doctor

    University Hospital, Angers

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Fabrice PRUNIER, Professor

CONTACT

+33241.355.147faprunier@chu-angers.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 17, 2013

First Posted

October 29, 2013

Study Start

October 1, 2013

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

October 29, 2013

Record last verified: 2013-10

Locations

FR(1)