Focus on Analysis of Recovery in Oximetry

NCT04376099 | Completed

• 1 other identifier: 2020/42
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

Analysis of localizations for symptoms and ischemia on treadmill and of the recovery profiles of patients that have had an exercise oximetry

Conditions

Intermittent Claudication

Outcome Measures

Primary Outcomes (1)

• Transcutanesous oximetry DROP index 50% recovery time

  Time for the DROP index to reach 50% of its minimal value from the end of walking

  Maximum 30 minutes (duration of the recovery phase)

Secondary Outcomes (2)

• Transcutanesous oximetry DROP index 90% recovery time

  Maximum 30 minutes (duration of the recovery phase)

• Concordance of pain and ischemia during the treadmill test

  Maximum 60 minutes (duration of each test)

Study Arms (1)

Exercise oximetry

Patients complaining claudication and referred for exercise diagnostic oximetry. Exercise oximetry are performed on treadmill (3.2km/h, 10% slope)

Diagnostic Test: Transcutaneous oxygen pressure measurement during the treadmill test

Interventions

Transcutaneous oxygen pressure measurement during the treadmill test DIAGNOSTIC_TEST

Calculation of the decrease from rest of oxygen pressure (DROP) throughout the period of rest exercise and recovery. The DROP is calculated as chanegs on each limb probe minus changes on a chest reference probe from rest. Analysis of the recovery period of the recordings will be done to seach for recovery 50% and 90% from the minimal DROP observed Evaluation of calf and non calf pain during the tests. Evaluation of calf and non calf (buttock or thigh) ischemia during the tests. Ischemia being defined as a monimal DROP lower than minus 15 mmHg.

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

Adult patients referred for exercise oximetry for intermittent claudication

You may qualify if:

• Available exercise oximetry recording

You may not qualify if:

• Deny of the use of the medical file from the patient

Sponsors & Collaborators

• University Hospital, Angers: lead

Study Sites (1)

University Hospital

Angers, 49933, France

Location

MeSH Terms

Conditions

Intermittent Claudication

Condition Hierarchy (Ancestors)

Peripheral Arterial Disease; Peripheral Vascular Diseases; Vascular Diseases; Cardiovascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Pierre ABRAHAM, MD; PhD

  UH in Angers (FRANCE)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2020
• First Posted: May 6, 2020
• Study Start: January 1, 2018
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: May 6, 2020

Record last verified: 2020-04

Locations

FR (1)