Lactate Increase in Peripheral Artery Disease

NCT03266861 | Completed

• 1 other identifier: 2017-A00912-51
• Study Type: observational
• Target: 750
• Locations: 1 country
• Sites: 1

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).

Conditions

Peripheral Artery Disease; Claudication, Intermittent

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Correlation of lactate results to resting Ankle to brachial index (ABI)

  one and a half hour

Study Arms (1)

Patients undergoing exercise oximetry

Patients with PAD referred for treadmill testing and exercise oximetry

Diagnostic Test: Exercise oximetry

Interventions

Exercise oximetry DIAGNOSTIC_TEST

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

Also known as: Capillary blood sampling from the earlobe

Patients undergoing exercise oximetry

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient with peripheral artery disease

You may qualify if:

• 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

You may not qualify if:

• Patient refuses to participate at the this protocol
• Patient has a wash-out period for another clinical trial

Sponsors & Collaborators

• University Hospital, Angers: lead

Study Sites (1)

Centre hospitalier universitaire

Angers, 49933, France

Location

MeSH Terms

Conditions

Peripheral Arterial Disease; Intermittent Claudication

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Pierre ABRAHAM, MD; PhD

  University Hospitaml in Angers

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2017
• First Posted: August 30, 2017
• Study Start: October 3, 2017
• Primary Completion: October 10, 2020
• Study Completion: October 10, 2020
• Last Updated: July 12, 2021

Record last verified: 2020-08

Locations

FR (1)