- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04911595
Evaluation of Muscle Ischemia in Arterial Claudication (Tsingtao) (Tsingtao)
June 2, 2021 updated by: University Hospital, Angers
Evaluation de l'Ischemie Musculaire au Cours de l'Artériopathie Oblitérante Des Membres Inférieurs
The goal is to compare the results observed in patients that had both an exercise oximetry and a thallium scintigraphy for lower limb claudication
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed 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
Study Type
Observational
Enrollment (Anticipated)
30
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: pierre abraham, MD; PhD
- Phone Number: +33 0241353689
- Email: piabraham@chu-angers.fr
Study Contact Backup
- Name: Marine Mauboussin
- Phone Number: +33 0668047430
- Email: marine.mauboussin@chu-angers.fr
Study Locations
-
-
-
Angers, France, 49933
- Recruiting
- Centre Hospitalier Universitaire
-
Contact:
- Pierre Abraham, MD, PhD
-
Principal Investigator:
- Pierre Abraham, MD PhD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients referred for claudication of suspected arterial
Description
Inclusion Criteria:
- Claudication suspected of arterial origin
Exclusion Criteria:
- missing endopoint value
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Correlation of thallium scintigraphy to oximetry results
Time Frame: 1 year
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: pierre abraham, MD; PhD, UH Angers
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 1, 2010
Primary Completion (Anticipated)
June 1, 2021
Study Completion (Anticipated)
June 1, 2021
Study Registration Dates
First Submitted
August 25, 2020
First Submitted That Met QC Criteria
June 2, 2021
First Posted (Actual)
June 3, 2021
Study Record Updates
Last Update Posted (Actual)
June 3, 2021
Last Update Submitted That Met QC Criteria
June 2, 2021
Last Verified
June 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CE-2018/109
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Peripheral Arterial Disease
-
University of NebraskaNot yet recruitingPeripheral Arterial Disease | Peripheral Vascular Diseases | Peripheral Arterial Occlusive Disease | Peripheral Artery DiseaseUnited States
-
CID S.p.A.Meditrial Europe Ltd.Not yet recruitingPeripheral Arterial Occlusive Disease | Peripheral Artery DiseaseItaly
-
Marissa JarosinskiRecruitingPeripheral Arterial Occlusive Disease | Peripheral Vascular Disease | Peripheral Artery Disease | Clopidogrel, Poor Metabolism of | Artery DiseaseUnited States
-
Stanford UniversityTerminatedPAD - Peripheral Arterial Disease | PVD- Peripheral Vascular DiseaseUnited States
-
Vascuros Medical Pte LtdNovella ClinicalUnknownPeripheral Arterial Occlusive Disease | Peripheral Vascular Disease | Peripheral Artery DiseaseSingapore, Belgium, Germany
-
Western Vascular Institute, IrelandRecruitingPeripheral Arterial Occlusive DiseaseIreland
-
Jena University HospitalAngioDroid s.r.l., Bologna (Italy)CompletedPeripheral Arterial Occlusive DiseaseGermany
-
Seoul National University HospitalAstellas Pharma Korea, Inc.CompletedPeripheral Arterial Occlusive DiseaseKorea, Republic of
-
Heidelberg UniversityTerminatedPeripheral Arterial Occlusive DiseaseGermany
-
Johann Wolfgang Goethe University HospitalSuspendedPeripheral Arterial Occlusive DiseaseGermany
Clinical Trials on exercise oximetry
-
University Hospital, AngersCompletedPeripheral Artery Disease | Claudication, IntermittentFrance
-
University of Wisconsin, MadisonRecruitingOxygen ConsumptionUnited States
-
Aristotle University Of ThessalonikiRecruitingCoronary Artery Disease | Aortic Valve Stenosis | Mitral DiseaseGreece
-
Medline IndustriesClinimark, LLCCompletedHealthy | Arterial Oxygen SaturationUnited States
-
Medline IndustriesClinimark, LLCTerminated
-
Malcolm KohlerActive, not recruitingObstructive Sleep ApneaSwitzerland
-
Aga Khan UniversityBill and Melinda Gates FoundationCompletedHypoxemia | Severe PneumoniaPakistan
-
Kasr El Aini HospitalCompletedHyperventilation | Infratentorial Neoplasms | CraniotomyEgypt
-
University Hospital, ToursCompletedNeuromuscular Diseases in Children | Neuromuscular Diseases in InfantsFrance
-
Central Hospital, Nancy, FranceNot yet recruiting