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STELLA: Lactate Increase in Peripheral Artery Disease

Sponsor
University Hospital, Angers (Other)
Overall Status
Completed
CT.gov ID
NCT03266861
Collaborator
(none)
750
Enrollment
1
Location
36.2
Actual Duration (Months)
20.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To our knowledge, the measurement of the transcutaneous oxygen pressure during walking is the only continuous method that estimates the importance of ischemia, bilaterally and segment of limb by segment of limb. The determination of the lactates concentration, with micro method from earlobe sampling, is very widely validated in physiology and exercise physiopathology; and it is widely used, by laboratories, for exercise investigation in athletes. We use it in routine to evaluate the presence of functional limitation during tcpO2 tests on a treadmill.

The present study hypothesises a significant relationship between lactatemia variation (difference between lactatemia after 3 minutes of recovery from walking and the value at rest) and tcpO2 "decrease from rest of oxygen pressure (DROP) values for patients with peripheral artery disease (PAD).

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Exercise oximetry

Detailed Description

Lactates sample (100 microliter) will be collected at rest Ankle brachial index is measured at rest transcutaneous oxygen pressure is measured at the chest, calves and buttocks and results will be expressed as the minimal value of the DROP index (Limb changes minus chest changes) Patients walk on treadmill (2MPH 10% slope) until exertional limb pain. Lactates sample (100 microliter) will be collected at minute 3 of recovery from walking Correlation of lactate increase to the sum of DROP values wil be studied

Study Design

Study Type:
Observational
Actual Enrollment :
750 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Study of Transcutaneous Exercise Oxymetry, reLationship to LActates Increase in Claudication
Actual Study Start Date :
Oct 3, 2017
Actual Primary Completion Date :
Oct 10, 2020
Actual Study Completion Date :
Oct 10, 2020

Arms and Interventions

Arm Intervention/Treatment
Patients undergoing exercise oximetry

Patients with PAD referred for treadmill testing and exercise oximetry

Diagnostic Test: Exercise oximetry
Sample at rest before the walking test Sample at rest 3 minutes after the end of the walking period
Other Names:
  • Capillary blood sampling from the earlobe

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Correlation of lactate results to oximetry [one and a half hour]

      Evaluate the coefficient of correlation between the lactatemia increase from rest and the sum of the observed DROP values of all studied subjects.

    Secondary Outcome Measures

    1. Correlation of lactate results to resting Ankle to brachial index (ABI) [one and a half hour]

      Evaluate the coefficient of correlation between the lactatemia increase from rest and the sum of the resting ABI value of all studied subjects..

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Age > 18 years old

    • Patient able to walk on a treadmill

    • Patient covered by the French health insurance

    • Patient able to understand the protocol

    • Patient agrees to be involve in the protocol and sign the consent form

    Exclusion Criteria:

    • Patient refuses to participate at the this protocol

    • Patient has a wash-out period for another clinical trial

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Centre hospitalier universitaire Angers France 49933

    Sponsors and Collaborators

    • University Hospital, Angers

    Investigators

    • Principal Investigator: Pierre ABRAHAM, MD; PhD, University Hospitaml in Angers

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Angers
    ClinicalTrials.gov Identifier:
    NCT03266861
    Other Study ID Numbers:
    • 2017-A00912-51
    First Posted:
    Aug 30, 2017
    Last Update Posted:
    Jul 12, 2021
    Last Verified:
    Aug 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Peripheral Arterial Disease
    Intermittent Claudication

    Study Results

    No Results Posted as of Jul 12, 2021