Ignite Creation Date:
2025-12-24 @ 11:38 PM
Ignite Modification Date:
2026-02-02 @ 6:41 AM
Study NCT ID:
NCT02834351
Status:
COMPLETED
Last Update Posted:
2016-12-19
First Post:
2016-06-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tissue Lesions in Exercise Related Ischemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D058729', 'term': 'Peripheral Arterial Disease'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-12', 'completionDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-12-15', 'studyFirstSubmitDate': '2016-06-16', 'studyFirstSubmitQcDate': '2016-07-14', 'lastUpdatePostDateStruct': {'date': '2016-12-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-07-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Activity differences in mitochondrial complex I between the distal and proximal levy in group 1 and group 2.', 'timeFrame': '1 week', 'description': 'Measurement of mitochondrial complex 1 activity (arbitrary units) on muscle biopsies by the laboratory of biochemistry. Comparison of the results observed on the same miuscle at the proximal level (assumed normal in both groups) and distal level (assumed ischemic in claudicants but not in cardiac patients without limb symptoms.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Ischemia', 'Peripheral Artery Disease']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the effect of muscle ischemia during claudication on mitochondrial function.\n\nComparison to patients with arterial disease but absence of lower limb claudication (Cardiac group) feasibility study.', 'detailedDescription': 'Assess the feasibility of the study of micro-vascular function and mitochondrial on muscle sample (sartorius) in a group of arterial disease and non arteriopathy group.\n\nAnalysis of the activity of mitochondrial chain Immunochemistry of tissue markers'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Intervention for femoropopliteal bypass (PAD group)\n* Intervention for saphenous withdrawal for coronary bypass surgery (cardiac group)\n\nExclusion Criteria:\n\n* Participate in another biomedical research\n* Pregnant woman'}, 'identificationModule': {'nctId': 'NCT02834351', 'acronym': 'SARTORIUS', 'briefTitle': 'Tissue Lesions in Exercise Related Ischemia', 'organization': {'class': 'OTHER_GOV', 'fullName': 'University Hospital, Angers'}, 'officialTitle': "Atteinte Tissulaire au Cours de l'ischémie Chronique d'Effort. Validation d'un modèle d'étude du Muscle Sartorius Humain", 'orgStudyIdInfo': {'id': '2013-A00166-39'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Peripheral artery diseased group', 'description': 'pad Patients referred for femoro popliteal bypass Muscle biopsy during surgery', 'interventionNames': ['Other: Muscle Biopsy']}, {'type': 'SHAM_COMPARATOR', 'label': 'Cardiac group', 'description': 'Patients referred for saphenous withdrawal for coronary bypass Muscle biopsy during surgery', 'interventionNames': ['Other: Muscle Biopsy']}], 'interventions': [{'name': 'Muscle Biopsy', 'type': 'OTHER', 'description': 'A distal and proximal biopsy of the sartorius muscles ( 0.5 cm3 each) will be performed during surgery for saphenous vein withdrawal (cardiac group) or arterial bypass (PAD group) The samples are then treated with neurovascular and mitochondrial biology laboratory.\n\nthe activity of the complex 1 is analyzed and compared between the 2 groups.', 'armGroupLabels': ['Cardiac group', 'Peripheral artery diseased group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '49933', 'city': 'Angers', 'country': 'France', 'facility': 'Uh Angers', 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}], 'overallOfficials': [{'name': 'Pierre ABRAHAM, PROFESSOR', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UH ANGERS'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Angers', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}