Lactate Increase in Peripheral Artery Disease

Peripheral Artery Disease Clinical Trial

— STELLA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03266861
• Other study ID #: 2017-A00912-51
• Status: Completed
• Start date: October 3, 2017
• Est. completion date: October 10, 2020

Study information

• Verified date: August 2020
• Source: University Hospital, Angers
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 750
• Est. completion date: October 10, 2020
• Est. primary completion date: October 10, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Claudication, Intermittent
• Intermittent Claudication
• Peripheral Arterial Disease
• Peripheral Artery Disease

Intervention

Diagnostic Test:
• Exercise oximetry
Sample at rest before the walking test Sample at rest 3 minutes after the end of the walking period

Locations

Country	Name	City	State
France	Centre hospitalier universitaire	Angers

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Angers

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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