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NCT04451018: SYSTOE-HAIDI
Evaluation of Macro and Microcirculatory Arterial Condition of the Upper Limb in Insufficiently Renal Patients
trial testing evaluation of arterial anomalies in upper limbs in Arteriopathy Upper Limb in 300 participants. Status unknown.
17 June 2025
Quick facts
| Lead sponsor | University Hospital, Grenoble |
|---|---|
| Status | Status unknown |
| Study type | OBSERVATIONAL |
| Enrollment | 300 |
| Start date | 17 June 2020 |
| Primary completion | 17 June 2025 |
| Estimated completion | 17 June 2025 |
| Sites | 1 location across France |
Drugs / interventions tested
- evaluation of arterial anomalies in upper limbs
Conditions studied
- Arteriopathy Upper Limb — all drugs for Arteriopathy Upper Limb →
- Renal Insufficiency — all drugs for Renal Insufficiency →
- Digital Pressure — all drugs for Digital Pressure →
Sponsor
University Hospital, Grenoble
Who can join
18 and older, any sex, with Arteriopathy Upper Limb or Renal Insufficiency. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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).
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04451018 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University Hospital, Grenoble
- Last refreshed: 23 December 2020
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