Ignite Creation Date:
2025-12-25 @ 4:37 AM
Ignite Modification Date:
2025-12-26 @ 3:39 AM
Study NCT ID:
NCT04451018
Status:
UNKNOWN
Last Update Posted:
2020-12-23
First Post:
2020-02-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of Macro and Microcirculatory Arterial Condition of the Upper Limb in Insufficiently Renal Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051437', 'term': 'Renal Insufficiency'}], 'ancestors': [{'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-06-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2025-06-17', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-12-22', 'studyFirstSubmitDate': '2020-02-14', 'studyFirstSubmitQcDate': '2020-06-25', 'lastUpdatePostDateStruct': {'date': '2020-12-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-17', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'arterial condition of the upper limbs', 'timeFrame': '24 HOURS', 'description': 'Description of the arterial condition with duplex ultrasound of the upper arteries: incompressibility or thrombosis of ulnar and/or radial arteries'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Arteriopathy Upper Limb', 'Renal Insufficiency', 'Digital Pressure']}, 'descriptionModule': {'briefSummary': 'Evaluation of macro and microcirculatory arterial condition of the upper limb in insufficiently renal patients\n\nHand 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.\n\nIn 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.\n\nThe 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).', 'detailedDescription': 'Prospective, monocentric study\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Chronic renal failure patient with nephrologist's decision to pre-dialysis", 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 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\n\nExclusion Criteria:\n\n* Subject under guardianship or subject deprived of liberty Failure to obtain patient's consent"}, 'identificationModule': {'nctId': 'NCT04451018', 'acronym': 'SYSTOE-HAIDI', 'briefTitle': 'Evaluation of Macro and Microcirculatory Arterial Condition of the Upper Limb in Insufficiently Renal Patients', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Grenoble'}, 'officialTitle': 'Evaluation of Macro and Microcirculatory Arterial Condition of the Upper Limb in Insufficiently Renal Patients', 'orgStudyIdInfo': {'id': '38RC19.285'}, 'secondaryIdInfos': [{'id': '2019-A02454-53', 'type': 'OTHER', 'domain': 'ID RCB'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'evaluation of arterial anomalies in upper limbs', 'type': 'OTHER', 'description': 'evaluation of arterial anomalies in upper limbs with doppler ultrasound'}]}, 'contactsLocationsModule': {'locations': [{'zip': '38043', 'city': 'Grenoble', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Sophie G BLAISE', 'role': 'CONTACT', 'phone': '+33 (0)4 76 76 55 47'}, {'name': 'Fatima BOUCHAFA', 'role': 'CONTACT', 'phone': '+33 (0)4 76 76 51 49'}], 'facility': 'Chu Grenoble Alpes', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}], 'centralContacts': [{'name': 'Sophie BLAISE', 'role': 'CONTACT', 'email': 'SBlaise@chu-grenoble.fr', 'phone': '+33(0)476 76 55 47', 'phoneExt': '+33'}, {'name': 'Fatima BOUCHAFA', 'role': 'CONTACT', 'phone': '04 76 76 51 49', 'phoneExt': '+33'}], 'overallOfficials': [{'name': 'Sophie BLAISE', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Grenoble'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Grenoble', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}