Ignite Creation Date:
2025-12-25 @ 3:47 AM
Ignite Modification Date:
2026-02-20 @ 6:23 PM
Study NCT ID:
NCT00848302
Status:
COMPLETED
Last Update Posted:
2017-03-07
First Post:
2009-02-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Endothelial Function in Human Arteries
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D016491', 'term': 'Peripheral Vascular Diseases'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001120', 'term': 'Arginine'}, {'id': 'D009569', 'term': 'Nitric Oxide'}], 'ancestors': [{'id': 'D024361', 'term': 'Amino Acids, Basic'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D000599', 'term': 'Amino Acids, Diamino'}, {'id': 'D000601', 'term': 'Amino Acids, Essential'}, {'id': 'D026361', 'term': 'Reactive Nitrogen Species'}, {'id': 'D005609', 'term': 'Free Radicals'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D009589', 'term': 'Nitrogen Oxides'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D010087', 'term': 'Oxides'}, {'id': 'D017601', 'term': 'Oxygen Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-06', 'studyFirstSubmitDate': '2009-02-12', 'studyFirstSubmitQcDate': '2009-02-19', 'lastUpdatePostDateStruct': {'date': '2017-03-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-02-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'IVUS mediated assessment of endothelial-dependent (EDR) and endothelial-independent (EIR) vasorelaxation before and after catheter-directed L-arginine delivery in patent arteries.', 'timeFrame': 'Procedural'}], 'secondaryOutcomes': [{'measure': 'Local arterial factors including peripheral L-arginine and nitrotyrosine levels via mass spectrometry and morphologic parameters of plaque composition.', 'timeFrame': 'Procedural'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['peripheral vascular disease', 'endothelial dysfunction', 'intravascular ultrasound', 'L-Arginine'], 'conditions': ['Endothelial Dysfunction']}, 'referencesModule': {'references': [{'pmid': '28366306', 'type': 'DERIVED', 'citation': 'Kashyap VS, Lakin RO, Campos P, Allemang M, Kim A, Sarac TP, Hausladen A, Stamler JS. The LargPAD Trial: Phase IIA evaluation of l-arginine infusion in patients with peripheral arterial disease. J Vasc Surg. 2017 Jul;66(1):187-194. doi: 10.1016/j.jvs.2016.12.127. Epub 2017 Mar 30.'}, {'pmid': '23830159', 'type': 'DERIVED', 'citation': 'Kashyap VS, Lakin RO, Feiten LE, Bishop PD, Sarac TP. In vivo assessment of endothelial function in human lower extremity arteries. J Vasc Surg. 2013 Nov;58(5):1259-66. doi: 10.1016/j.jvs.2013.05.029. Epub 2013 Jul 3.'}]}, 'descriptionModule': {'briefSummary': 'Up to 30 patients with lower extremity disease scheduled to undergo diagnostic angiography will undergo baseline bloodwork and IVUS (intravascular ultrasound), followed by dosing with L-arginine to assess changes in endothelial function.', 'detailedDescription': 'We will assess doses of regional L-arginine supplementation in patients undergoing elective angiography for lower extremity PAD. Assessment of EDR and EIR with IVUS in patent arteries will be performed with one of 3 doses of catheter-directed L-arginine. We will obtain plasma samples from the peripheral arteries and assay amino acid levels and protein oxidation products using mass spectrometry. These experiments will determine the optimal L-arginine supplementation dose to be used in further studies. We expect to show that L-arginine supplementation will have a more significant effect on vessels less affected by atherosclerosis, but that this effect diminishes with greater atheroma accumulation as measured by IVUS virtual histology. Also, we expect L-arginine supplementation to be most effective in vessels with low baseline L-arginine levels. Lastly, we will compare local arterial factors obtained via catheter-directed arterial sampling (NOx, L-arginine, nitrotyrosine levels) to traditional serum risk factors (glucose, HbA1c, LDL, homocysteine and hs C-reactive protein).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age \\>18 years\n* symptoms of intermittent claudication, rest pain or minor tissue loss (Rutherford Category I-V)\n* ABI of \\<.90\n* angiographic demonstration of a 100mm patent segment of superficial femoral artery containing at least one distal runoff vessel\n\nExclusion Criteria:\n\n* acute limb ischemia,\n* contraindication to angiography (creatinine \\>2.5)\n* concurrent oral anticoagulant therapy that cannot be safely withheld\n* extensive tissue loss or gangrene'}, 'identificationModule': {'nctId': 'NCT00848302', 'briefTitle': 'Endothelial Function in Human Arteries', 'organization': {'class': 'OTHER', 'fullName': 'The Cleveland Clinic'}, 'officialTitle': 'Endothelial Function in Human Arteries', 'orgStudyIdInfo': {'id': 'K23HLOBO247'}, 'secondaryIdInfos': [{'id': 'K23HLOBO247', 'type': 'OTHER', 'domain': 'National Heart Lung Blood Institute'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'L-arginine', 'description': 'Assess the effects of regional L-arginine supplementation in patients with chronic lower extremity occlusive disease undergoing angiography', 'interventionNames': ['Drug: L-arginine']}], 'interventions': [{'name': 'L-arginine', 'type': 'DRUG', 'otherNames': ['Nitric oxide'], 'description': '30 patients will receive either 50, 100 or 500mg L-arginine supplementation infused via a end-hole catheter', 'armGroupLabels': ['L-arginine']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Vikram Kashyap, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cleveland Clinic Vascular Surgery'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Cleveland Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}