Lactate Increase in Peripheral Artery Disease

NCT ID: NCT03266861

Last Updated: 2021-07-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

750 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-10-03

Study Completion Date

2020-10-10

Brief Summary

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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).

Detailed Description

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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

Conditions

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Peripheral Artery Disease Claudication, Intermittent

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients undergoing exercise oximetry

Patients with PAD referred for treadmill testing and exercise oximetry

Exercise oximetry

Intervention Type DIAGNOSTIC_TEST

Sample at rest before the walking test Sample at rest 3 minutes after the end of the walking period

Interventions

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Exercise oximetry

Sample at rest before the walking test Sample at rest 3 minutes after the end of the walking period

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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Capillary blood sampling from the earlobe

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Angers

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pierre ABRAHAM, MD; PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospitaml in Angers

Locations

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Centre hospitalier universitaire

Angers, , France

Site Status

Countries

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France

Other Identifiers

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2017-A00912-51

Identifier Type: -

Identifier Source: org_study_id

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