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NCT04911595 Clinical Trial

Evaluation of Muscle Ischemia in Arterial Claudication (Tsingtao)

Peripheral Arterial Disease Clinical Trial

— Tsingtao  

Official title:
Evaluation de l'Ischemie Musculaire au Cours de l'Artériopathie Oblitérante Des Membres Inférieurs

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04911595
Other study ID # CE-2018/109
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date June 2010
Est. completion date June 2021

Study information
Verified date June 2021
Source University Hospital, Angers
Contact pierre abraham, MD; PhD
Phone 0241353689
Email piabraham@chu-angers.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The goal is to compare the results observed in patients that had both an exercise oximetry and a thallium scintigraphy for lower limb claudication

Description:

On our routine pratice, patients suffering claudication (specifically atypical claudication or claudication of doubful vascular origin) have exercise oximetry to prove the vascular origin of pain. If still doubtful (inconsistency of pain and oximetry results) patients are referred for thallium scintigraphy. Our goal is to compare the results issued from these two test

Recruitment information / eligibility
Status Recruiting
Enrollment 30
Est. completion date June 2021
Est. primary completion date June 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Claudication suspected of arterial origin Exclusion Criteria: - missing endopoint value

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• exercise oximetry
transcutaneous oxygen pressure is measured at the skin level on chest , buttocks and calves during a walking test 3.2 km*:h 10% slope. From the test result the decrease from rest of oxygen pressure (DROP) index is calculated to estimate muscle ischemia
• thallium scintigraphy
Muscle thallium fixation is measured immediately after a walking test 3.2 km*:h 10% slope and at 4 hours after the test. From the test result the difference of late and early radioactivity is calculated at the buttock and calf level and normalized to total body radioactivity to estimate muscle ischemia

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 thallium scintigraphy to oximetry results The coefficient of correlation of DROP values to normalized late to early changes in radioactivity wil be calculated at the calf and buttock level 1 year
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