Peripheral Arterial DiseaseTsingtaoNCT04911595
Evaluation of Muscle Ischemia in Arterial Claudication (Tsingtao)
An observational study of Peripheral Arterial Disease, run by University Hospital, Angers at 1 site in France.
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Arterial Disease
- What is being tested?
- exercise oximetry and thallium scintigraphy
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2010to Jun 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients referred for claudication of suspected arterial
Who may be able to join
- Claudication suspected of arterial origin
Who cannot join
- missing endopoint value
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Centre hospitalier universitaire
Angers, 49933
Pierre Abraham, MD, PhD
Pierre Abraham, MD PhD
About this study
Official title: 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
Read the 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
- Conditions
- Peripheral Arterial Disease
- Being tested
- exercise oximetry, thallium scintigraphy
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2021
- Study startJun 2010
- Primary completionJun 2021 (estimated)
- Study completionJun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- pierre abraham, MD; PhD, Principal investigator, UH Angers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04911595
- Sponsor's protocol ID
- CE-2018/109
- Acronym
- Tsingtao
- Status last verified
- Jun 2021
- First submitted
- 25 Aug 2020
- Last updated
- 3 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation de l'Ischemie Musculaire au Cours de l'Artériopathie Oblitérante Des Membres Inférieurs
- ClinicalTrials.gov ID
- NCT04911595
- Acronym / sponsor ID
- Tsingtao / CE-2018/109
- Conditions
- Peripheral Arterial Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- Jun 2010 (actual)
- Primary completion
- Jun 2021 (estimated)
- Study completion
- Jun 2021 (estimated)
- First posted
- 3 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal is to compare the results observed in patients that had both an exercise oximetry and a thallium scintigraphy for lower limb claudication
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients referred for claudication of suspected arterial
Key inclusion criteria (1 listed)
- Claudication suspected of arterial origin
Key exclusion criteria (1 listed)
- missing endopoint value
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| exercise oximetrytranscutaneous 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 | Diagnostic test | – |
| thallium scintigraphyMuscle 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 | Diagnostic test | – |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2021.
- Individual participant dataSharing planned: Undecided
Related trials for Peripheral Arterial Disease
Active, not recruiting
SUCCESS (SelUtion, Safety, effiCaCy, hEalth economicS and promS) PTA Study
Peripheral Artery Disease
RecruitingPhase 3
Reducing Adverse Vascular Outcomes With Factor XI Inhibition in Adult Participants With Peripheral Artery Disease
Peripheral Artery Disease (PAD)
Recruiting
The THOR IDE Study
Peripheral Artery Disease, Peripheral Artery Stenosis
Not yet recruiting
Daily Stretching to Improve Walking in Older Patients With Peripheral Artery Disease: The STRETCH PAD Study
Peripheral Artery Disease (PAD), Intermittent Claudication
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
pierre abraham, MD; PhD principal investigator
UH Angers
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peripheral Arterial Disease, run by University Hospital, Angers at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact pierre abraham, MD; PhD (0241353689 ext. +33, piabraham@chu-angers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation of thallium scintigraphy to oximetry results (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2021.