NCT04911595

Brief 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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2010

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2010

Completed
10.2 years until next milestone

First Submitted

Initial submission to the registry

August 25, 2020

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 3, 2021

Completed
Last Updated

June 3, 2021

Status Verified

June 1, 2021

Enrollment Period

11 years

First QC Date

August 25, 2020

Last Update Submit

June 2, 2021

Conditions

Peripheral Arterial Disease

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

exercise oximetryDIAGNOSTIC_TEST

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 scintigraphyDIAGNOSTIC_TEST

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients referred for claudication of suspected arterial

You may qualify if:

  • Claudication suspected of arterial origin

You may not qualify if:

  • missing endopoint value

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre hospitalier universitaire

Angers, 49933, France

RECRUITING

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

AtherosclerosisArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesPeripheral Vascular Diseases

Study Officials

  • pierre abraham, MD; PhD

    UH Angers

    PRINCIPAL INVESTIGATOR

Central Study Contacts

pierre abraham, MD; PhD

CONTACT

0241353689piabraham@chu-angers.fr

Marine Mauboussin

CONTACT

0668047430marine.mauboussin@chu-angers.fr

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 25, 2020

First Posted

June 3, 2021

Study Start

June 1, 2010

Primary Completion

June 1, 2021

Study Completion

June 1, 2021

Last Updated

June 3, 2021

Record last verified: 2021-06

Locations

FR(1)