Ignite Creation Date:
2025-12-24 @ 5:47 PM
Ignite Modification Date:
2025-12-25 @ 3:14 PM
Study NCT ID:
NCT03490968
Status:
COMPLETED
Last Update Posted:
2024-02-29
First Post:
2018-03-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Impact of Branched-Chain Amino Acid Metabolism on Limb Dysfunction in PAD
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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-05-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2023-08-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-27', 'studyFirstSubmitDate': '2018-03-30', 'studyFirstSubmitQcDate': '2018-03-30', 'lastUpdatePostDateStruct': {'date': '2024-02-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-04-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'C3/C5acylcarnitine levels in healthy control subjects.', 'timeFrame': 'baseline'}, {'measure': 'C3/C5acylcarnitine levels in PAD exercise group after 12 weeks', 'timeFrame': 'Change from baseline to 12 weeks'}, {'measure': 'C3/C5 acylcarnitine levels in PAD surgical bypass group', 'timeFrame': 'Change from baseline to 12 weeks'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Peripheral Arterial Disease']}, 'referencesModule': {'references': [{'pmid': '40905129', 'type': 'DERIVED', 'citation': 'Sullivan AE, Behroozian A, Coolbaugh C, Shardelow E, Smith EK, Wells QS, Clair DG, Aday AW, Garrard CL 3rd, Curci JA, Holder TA, Barnett JV, Freiberg MS, Crescenzi RL, Wakeham DJ, Hearon CM Jr, Donahue MJ, Beckman JA. Microvascular Function and Ambulatory Capacity in Peripheral Artery Disease. Circ Cardiovasc Interv. 2025 Oct;18(10):e015582. doi: 10.1161/CIRCINTERVENTIONS.125.015582. Epub 2025 Sep 4.'}]}, 'descriptionModule': {'briefSummary': "Test the theory that abnormalities in the large blood vessels that deliver blood to your leg and the very small blood vessels in your leg's muscles (invisible to the eye) work together to worsen your leg function and walking."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion/exclusion criteria for Healthy Subjects\n\nInclusion criteria\n\n* Male or female, age ≥ 50 years old\n* Non-smoker\n\nExclusion criteria\n\n* Presence of peripheral artery disease\n* History of a heart attack or stroke\n* Diabetes\n* Active cancer\n* Severe renal disease (CrCl \\< 60)\n* Severe liver disease\n* Active rheumatological diseases\n\nInclusion/exclusion criteria for PAD Subjects\n\nInclusion criteria\n\n* Male or female, age 50 years or older\n* Atherosclerotic PAD, ABI ≤0.85\n* Willing to comply with protocol, attend follow-up appointments, complete all study assessments, and provide informed consent\n* For Aim 3, subjects will have Rutherford stage 4 or 5 disease\n* For Aim 3, subjects will be undergoing revascularization as standard of care\n\nExclusion criteria\n\n* Presence of a femoral, popliteal or tibial aneurysm of the index limb\n* Life expectancy less than 2 years\n* A vascular disease prognosis that includes an anticipated above ankle amputation on index limb within 4 weeks of index procedure\n* Renal dysfunction defined as MDRD eGFR ≤ 20ml/min/173 m2 at the time of screening\n* Currently on dialysis or history of a renal transplant\n* Cirrhosis or active hepatitis\n* A documented hypercoagulable state\n* Myocardial infarction within 6 months\n* Stroke within 6 months\n* Nonatherosclerotic occlusive disease of the lower extremity\n* Any prior infrainguinal revascularization on index limb\n* Current immunosuppressive medication, chemotherapy or radiation therapy\n* Inability to have an MRI\n* Exercise limitation aside from that due to PAD (i.e. COPD, degenerative joint disease, etc.)\n* Women who are pregnant\n* Women who are nursing\n* Primary indications for systemic oral anticoagulation for active arterial or venous thromboembolic disease.'}, 'identificationModule': {'nctId': 'NCT03490968', 'briefTitle': 'The Impact of Branched-Chain Amino Acid Metabolism on Limb Dysfunction in PAD', 'organization': {'class': 'OTHER', 'fullName': 'Vanderbilt University Medical Center'}, 'officialTitle': 'The Impact of Branched-Chain Amino Acid Metabolism on Limb Dysfunction in PAD (MicroPAD)', 'orgStudyIdInfo': {'id': '180441'}, 'secondaryIdInfos': [{'id': '18SFRN33900069', 'type': 'OTHER_GRANT', 'domain': 'American Heart Association'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Healthy Subjects', 'interventionNames': ['Behavioral: Vascular Assessment']}, {'type': 'EXPERIMENTAL', 'label': 'Peripheral Artery Disease (PAD) with Supervised Exercise', 'description': 'Subjects will be referred for supervised exercise therapy. Subjects will have 3 visits per week for 12 weeks. Each visit will include a minimum of 30 to 40 minutes of exercise to improve ambulation with a certified trainer.', 'interventionNames': ['Behavioral: Supervised Exercise', 'Behavioral: Vascular Assessment']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'PAD Subjects Who Undergo Revascularization of the Leg', 'description': 'This group of subjects are receiving leg revascularization as part of standard of care.', 'interventionNames': ['Behavioral: Vascular Assessment']}], 'interventions': [{'name': 'Supervised Exercise', 'type': 'BEHAVIORAL', 'description': 'Subjects will have 3 visits per week for 12 weeks.', 'armGroupLabels': ['Peripheral Artery Disease (PAD) with Supervised Exercise']}, {'name': 'Vascular Assessment', 'type': 'BEHAVIORAL', 'description': 'Screen: Subjects will undergo a H\\&P, ankle brachial index, ECG, CBC, CMP, lipid panel, HgA1C, and urinalysis. A urine pregnancy test will be performed on women of childbearing age.\n\nTesting Visit 1: MRI, IV in common femoral vein with phlebotomy (60 cc total) before and after sphygmomanometric cuff occlusion of lower limb, 6-minute walk test, 4-meter walk speed test, walking impairment questionnaire, and muscle biopsy.\n\nSupervised exercise and leg revascularization patients will return in 12 weeks and have the same study procedures as testing visit 1, plus an ankle brachial index, repeated.', 'armGroupLabels': ['Healthy Subjects', 'PAD Subjects Who Undergo Revascularization of the Leg', 'Peripheral Artery Disease (PAD) with Supervised Exercise']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt University Medical Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}], 'overallOfficials': [{'name': 'Joshua Beckman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Vanderbilt University Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vanderbilt University Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'American Heart Association', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Joshua Beckman', 'investigatorAffiliation': 'Vanderbilt University Medical Center'}}}}