Arteriopathy Upper LimbSYSTOE-HAIDINCT04451018
Evaluation of Macro and Microcirculatory Arterial Condition of the Upper Limb in Insufficiently Renal Patients
An observational study of Arteriopathy Upper Limb and Renal Insufficiency, run by University Hospital, Grenoble at 1 site in France.
Trial summary
Evaluation of macro and microcirculatory arterial condition of the upper limb in insufficiently renal patients Hand ischemia affects 1.6 to 8% of patients with arteriovenous fistula (FAV) of hemodialysis in the upper limb. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arteriopathy Upper Limb, Renal Insufficiency, Digital Pressure
- What is being tested?
- evaluation of arterial anomalies in upper limbs
- How many people
- 300 participants
- Where
- 1 siteFrance
- Study dates
- 17 Jun 2020to 17 Jun 2025
- 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: Chronic renal failure patient with nephrologist's decision to pre-dialysis
Who may be able to join
- Chronic renal failure patient with nephrologist's decision to pre-dialysis Or Chronic renal insufficient patient with arteriovenous fistula of the upper limb and sign of digital ischemia (cold hand, digital ulcer, digital necrosis) Agreement on the study's non-opposition form Age above or equal 18 years Patient affiliated with a social security plan
Who cannot join
- Subject under guardianship or subject deprived of liberty Failure to obtain patient's consent
Trial locations and contacts
1 site in 1 country.
Fatima BOUCHAFA contact
France1 site, 1 recruiting
- Recruiting
Chu Grenoble Alpes
Grenoble, 38043
Sophie G BLAISE, +33 (0)4 76 76 55 47
Fatima BOUCHAFA, +33 (0)4 76 76 51 49
About this study
Evaluation of macro and microcirculatory arterial condition of the upper limb in insufficiently renal patients
Hand ischemia affects 1.6 to 8% of patients with arteriovenous fistula (FAV) of hemodialysis in the upper limb. The diagnostic and therapeutic stakes are major as it concerns the functional prognosis of the hand and, to a lesser extent, vascular access for hemodialysis.
Read more
In some cases, the diagnosis of ischemic hemo-hijacking is evident, in other cases, the ischemic condition appears to be rather the result of uncompensated arteriatory of the upper limb or limbs. Echo-doppler exploration is usual for assessing vascular access but without validated formal criteria for arterial disease in the upper limbs, with fistula flow calculation and analysis of FAV hemodynamics. Compression manoeuvres on or under the FAV can also be performed. The pressures of the digital arteries are also indicated with non-consensual values found in the literature for the diagnosis of digital ischemia but with varying tools in terms of collection of measurements.
The main objective of this study is to collate the characteristics of arterial condition of the upper limbs of medium or severe renal patients, medium- or short-term candidates for kidney dialysis. The data collected will match the data of the arterial echodoppler as well as measures of pressures doppler laser and plethysmography. Candidates for dialysis tend to be older and polyvascular. A better assessment of the vascular condition of their upper limbs, including the diagnosis of advanced arterial disease, could eventually guide the choice of type of dialysis (compared to an indication of FAV).
Read the detailed description
Prospective, monocentric study
The main objective of the research Description of the arterial condition of the upper limbs of kidney failure patients candidates for dialysis Primary Search Judgment Criterion: Description of the ultrasound characteristics of the arterial echo-doppler of the upper limbs.
- Being tested
- evaluation of arterial anomalies in upper limbs
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
evaluation of arterial anomalies in upper limbsOther
evaluation of arterial anomalies in upper limbs with doppler ultrasound
What is being measured
The primary outcome is the main question the study is designed to answer.
arterial condition of the upper limbs
Description of the arterial condition with duplex ultrasound of the upper arteries: incompressibility or thrombosis of ulnar and/or radial arteries
Measured: 24 HOURS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2020
- Study start17 Jun 2020
- Primary completion17 Jun 2025 (estimated)
- Study completion17 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arteriopathy Upper LimbStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sophie BLAISE, Principal investigator, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04451018
- Sponsor's protocol ID
- 38RC19.285
- Other IDs
- 2019-A02454-53
- Acronym
- SYSTOE-HAIDI
- Status last verified
- Dec 2020
- First submitted
- 14 Feb 2020
- Last updated
- 23 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Macro and Microcirculatory Arterial Condition of the Upper Limb in Insufficiently Renal Patients
- ClinicalTrials.gov ID
- NCT04451018
- Acronym / sponsor ID
- SYSTOE-HAIDI / 38RC19.285
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- 17 Jun 2020 (actual)
- Primary completion
- 17 Jun 2025 (estimated)
- Study completion
- 17 Jun 2025 (estimated)
- First posted
- 30 Jun 2020 (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.
Evaluation of macro and microcirculatory arterial condition of the upper limb in insufficiently renal patients
Hand ischemia affects 1.6 to 8% of patients with arteriovenous fistula (FAV) of hemodialysis in the upper limb. The diagnostic and therapeutic stakes are major as it concerns the functional prognosis of the hand and, to a lesser extent, vascular access for hemodialysis.
In some cases, the diagnosis of ischemic hemo-hijacking is evident, in other cases, the ischemic condition appears to be rather the result of uncompensated arteriatory of the upper limb or limbs. Echo-doppler exploration is usual for assessing vascular access but without validated formal criteria for arterial disease in the upper limbs, with fistula flow calculation and analysis of FAV hemodynamics. Compression manoeuvres on or under the FAV can also be performed. The pressures of the digital arteries are also indicated with non-consensual values found in the literature for the diagnosis of digital ischemia but with varying tools in terms of collection of measurements.
The main objective of this study is to collate the characteristics of arterial condition of the upper limbs of medium or severe renal patients, medium- or short-term candidates for kidney dialysis. The data collected will match the data of the arterial echodoppler as well as measures of pressures doppler laser and plethysmography. Candidates for dialysis tend to be older and polyvascular. A better assessment of the vascular condition of their upper limbs, including the diagnosis of advanced arterial disease, could eventually guide the choice of type of dialysis (compared to an indication of FAV).
Detailed description
Prospective, monocentric study
The main objective of the research Description of the arterial condition of the upper limbs of kidney failure patients candidates for dialysis Primary Search Judgment Criterion: Description of the ultrasound characteristics of the arterial echo-doppler of the upper limbs.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Chronic renal failure patient with nephrologist's decision to pre-dialysis
Key inclusion criteria (1 listed)
- Chronic renal failure patient with nephrologist's decision to pre-dialysis Or Chronic renal insufficient patient with arteriovenous fistula of the upper limb and sign of digital ischemia (cold hand, digital ulcer, digital necrosis) Agreement on the study's non-opposition form Age above or equal 18 years Patient affiliated with a social security plan
Key exclusion criteria (1 listed)
- Subject under guardianship or subject deprived of liberty Failure to obtain patient's consent
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 |
|---|---|---|
| evaluation of arterial anomalies in upper limbsevaluation of arterial anomalies in upper limbs with doppler ultrasound | Other | – |
Primary outcome
arterial condition of the upper limbs
Time frame: 24 HOURS
Description of the arterial condition with duplex ultrasound of the upper arteries: incompressibility or thrombosis of ulnar and/or radial arteries
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2020.
- Individual participant dataSharing planned: No
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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.
Fatima BOUCHAFA contact
Sophie BLAISE principal investigator
University Hospital, Grenoble
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 Arteriopathy Upper Limb and Renal Insufficiency, run by University Hospital, Grenoble 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 23 Dec 2020. 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 Sophie BLAISE (+33(0)476 76 55 47 ext. +33, SBlaise@chu-grenoble.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
arterial condition of the upper limbs (time frame: 24 HOURS). 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 23 Dec 2020.