Ignite Creation Date:
2025-12-24 @ 2:17 PM
Ignite Modification Date:
2025-12-26 @ 6:18 PM
Study NCT ID:
NCT04911595
Status:
UNKNOWN
Last Update Posted:
2021-06-03
First Post:
2020-08-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Muscle Ischemia in Arterial Claudication (Tsingtao)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058729', 'term': 'Peripheral Arterial Disease'}], 'ancestors': [{'id': 'D050197', 'term': 'Atherosclerosis'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D016491', 'term': 'Peripheral Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2021-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-06-02', 'studyFirstSubmitDate': '2020-08-25', 'studyFirstSubmitQcDate': '2021-06-02', 'lastUpdatePostDateStruct': {'date': '2021-06-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Correlation of thallium scintigraphy to oximetry results', 'timeFrame': '1 year', 'description': 'The coefficient of correlation of DROP values to normalized late to early changes in radioactivity wil be calculated at the calf and buttock level'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Peripheral Arterial Disease']}, 'descriptionModule': {'briefSummary': 'The goal is to compare the results observed in patients that had both an exercise oximetry and a thallium scintigraphy for lower limb claudication', 'detailedDescription': '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'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients referred for claudication of suspected arterial', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Claudication suspected of arterial origin\n\nExclusion Criteria:\n\n* missing endopoint value'}, 'identificationModule': {'nctId': 'NCT04911595', 'acronym': 'Tsingtao', 'briefTitle': 'Evaluation of Muscle Ischemia in Arterial Claudication (Tsingtao)', 'organization': {'class': 'OTHER_GOV', 'fullName': 'University Hospital, Angers'}, 'officialTitle': "Evaluation de l'Ischemie Musculaire au Cours de l'Artériopathie Oblitérante Des Membres Inférieurs", 'orgStudyIdInfo': {'id': 'CE-2018/109'}}, 'armsInterventionsModule': {'interventions': [{'name': 'exercise oximetry', 'type': 'DIAGNOSTIC_TEST', 'description': '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'}, {'name': 'thallium scintigraphy', 'type': 'DIAGNOSTIC_TEST', 'description': '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'}]}, 'contactsLocationsModule': {'locations': [{'zip': '49933', 'city': 'Angers', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Pierre Abraham, MD, PhD', 'role': 'CONTACT'}, {'name': 'Pierre Abraham, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Centre hospitalier universitaire', 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}], 'centralContacts': [{'name': 'pierre abraham, MD; PhD', 'role': 'CONTACT', 'email': 'piabraham@chu-angers.fr', 'phone': '0241353689', 'phoneExt': '+33'}, {'name': 'Marine Mauboussin', 'role': 'CONTACT', 'email': 'marine.mauboussin@chu-angers.fr', 'phone': '0668047430', 'phoneExt': '+33'}], 'overallOfficials': [{'name': 'pierre abraham, MD; PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UH Angers'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Angers', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}