Lactate Increase in Peripheral Artery Disease (STELLA)

Study of Transcutaneous Exercise Oxymetry, reLationship to LActates Increase in Claudication

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).

Study Overview

• Status: Completed
• Conditions: Peripheral Artery Disease; Claudication, Intermittent
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 750

Contacts and Locations

Study Locations

• France
  • Angers, France, 49933
    • Centre Hospitalier Universitaire

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

Patient with peripheral artery disease

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation of lactate results to oximetry	Evaluate the coefficient of correlation between the lactatemia increase from rest and the sum of the observed DROP values of all studied subjects.	one and a half hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation of lactate results to resting Ankle to brachial index (ABI)	Evaluate the coefficient of correlation between the lactatemia increase from rest and the sum of the resting ABI value of all studied subjects..	one and a half hour

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): October 3, 2017
• Primary Completion (Actual): October 10, 2020
• Study Completion (Actual): October 10, 2020

Study Registration Dates

• First Submitted: August 22, 2017
• First Submitted That Met QC Criteria: August 29, 2017
• First Posted (Actual): August 30, 2017

Study Record Updates

• Last Update Posted (Actual): July 12, 2021
• Last Update Submitted That Met QC Criteria: July 9, 2021
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Vascular Diseases; Peripheral Arterial Disease; Intermittent Claudication
• Other Study ID Numbers: 2017-A00912-51

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No