Ignite Creation Date:
2025-12-24 @ 11:07 PM
Ignite Modification Date:
2025-12-25 @ 8:39 PM
Study NCT ID:
NCT03590769
Status:
COMPLETED
Last Update Posted:
2020-11-30
First Post:
2018-05-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Arterial Imaging of Inflammation and Resolution After Endovascular Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058729', 'term': 'Peripheral Arterial Disease'}, {'id': 'D007383', 'term': 'Intermittent Claudication'}, {'id': 'D061205', 'term': 'Vascular Calcification'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}], 'ancestors': [{'id': 'D050197', 'term': 'Atherosclerosis'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D016491', 'term': 'Peripheral Vascular Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D002114', 'term': 'Calcinosis'}, {'id': 'D002128', 'term': 'Calcium Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019788', 'term': 'Fluorodeoxyglucose F18'}], 'ancestors': [{'id': 'D003847', 'term': 'Deoxyglucose'}, {'id': 'D003837', 'term': 'Deoxy Sugars'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Patient undergoing percutaneous angioplasty of SFA or popliteal artery, or stenting of the iliac artery or SFA, will have 18F-FDG-PET scan at the region of interest before intervention, then post-operatively 1 day and 1 week from treatment.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 9}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2019-09-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-11-25', 'studyFirstSubmitDate': '2018-05-16', 'studyFirstSubmitQcDate': '2018-07-16', 'lastUpdatePostDateStruct': {'date': '2020-11-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-07-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-09-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes found in the quantitative measure of FDG-PET uptake at intervention site prior to and after peripheral vascular injury.', 'timeFrame': '1 time each week for 3 weeks', 'description': 'Patient is given 18F-FDG radio tracer. The tracer is quantitatively measured through FDG-PET imaging modality for uptake at the intervention site.'}], 'secondaryOutcomes': [{'measure': 'Changes in the correlating the inflammatory and resolution response prior to and after peripheral vascular injury.', 'timeFrame': '1 time each week for 3 weeks', 'description': 'Venipuncture of subject and collection of blood allows measures pro-inflammatory markers and targeted metabolipodimics.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Peripheral Arterial Disease', 'PAD', 'Claudication, Intermittent', 'Claudication', 'SFA Occlusion', 'Arterial Occlusion', 'Iliac Artery Occlusion', 'Vascular Calcification'], 'conditions': ['Peripheral Arterial Disease', 'Claudication, Intermittent', 'Claudication', 'PAD', 'SFA - Superficial Femoral Artery Stenosis', 'Iliac Artery Disease', 'Vascular Calcification']}, 'referencesModule': {'references': [{'pmid': '24721799', 'type': 'BACKGROUND', 'citation': 'Armstrong EJ, Chen DC, Westin GG, Singh S, McCoach CE, Bang H, Yeo KK, Anderson D, Amsterdam EA, Laird JR. Adherence to guideline-recommended therapy is associated with decreased major adverse cardiovascular events and major adverse limb events among patients with peripheral arterial disease. J Am Heart Assoc. 2014 Apr 10;3(2):e000697. doi: 10.1161/JAHA.113.000697.'}, {'pmid': '23915883', 'type': 'BACKGROUND', 'citation': 'Fowkes FG, Rudan D, Rudan I, Aboyans V, Denenberg JO, McDermott MM, Norman PE, Sampson UK, Williams LJ, Mensah GA, Criqui MH. Comparison of global estimates of prevalence and risk factors for peripheral artery disease in 2000 and 2010: a systematic review and analysis. Lancet. 2013 Oct 19;382(9901):1329-40. doi: 10.1016/S0140-6736(13)61249-0. Epub 2013 Aug 1.'}, {'pmid': '19738135', 'type': 'BACKGROUND', 'citation': 'Conen D, Rexrode KM, Creager MA, Ridker PM, Pradhan AD. Metabolic syndrome, inflammation, and risk of symptomatic peripheral artery disease in women: a prospective study. Circulation. 2009 Sep 22;120(12):1041-7. doi: 10.1161/CIRCULATIONAHA.109.863092. Epub 2009 Sep 8.'}, {'pmid': '17123769', 'type': 'BACKGROUND', 'citation': 'Owens CD, Ridker PM, Belkin M, Hamdan AD, Pomposelli F, Logerfo F, Creager MA, Conte MS. Elevated C-reactive protein levels are associated with postoperative events in patients undergoing lower extremity vein bypass surgery. J Vasc Surg. 2007 Jan;45(1):2-9; discussion 9. doi: 10.1016/j.jvs.2006.08.048. Epub 2006 Nov 21.'}, {'pmid': '18195333', 'type': 'BACKGROUND', 'citation': 'Vidula H, Tian L, Liu K, Criqui MH, Ferrucci L, Pearce WH, Greenland P, Green D, Tan J, Garside DB, Guralnik J, Ridker PM, Rifai N, McDermott MM. Biomarkers of inflammation and thrombosis as predictors of near-term mortality in patients with peripheral arterial disease: a cohort study. Ann Intern Med. 2008 Jan 15;148(2):85-93. doi: 10.7326/0003-4819-148-2-200801150-00003.'}, {'pmid': '18410327', 'type': 'BACKGROUND', 'citation': "Carriere I, Dupuy AM, Lacroux A, Cristol JP, Delcourt C; Pathologies Oculaires Liees a l'Age Study Group. 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Epub 2011 Jan 4.'}, {'pmid': '23186989', 'type': 'BACKGROUND', 'citation': "Mizwicki MT, Liu G, Fiala M, Magpantay L, Sayre J, Siani A, Mahanian M, Weitzman R, Hayden EY, Rosenthal MJ, Nemere I, Ringman J, Teplow DB. 1alpha,25-dihydroxyvitamin D3 and resolvin D1 retune the balance between amyloid-beta phagocytosis and inflammation in Alzheimer's disease patients. J Alzheimers Dis. 2013;34(1):155-70. doi: 10.3233/JAD-121735."}, {'pmid': '22538616', 'type': 'BACKGROUND', 'citation': 'Chiang N, Fredman G, Backhed F, Oh SF, Vickery T, Schmidt BA, Serhan CN. Infection regulates pro-resolving mediators that lower antibiotic requirements. Nature. 2012 Apr 25;484(7395):524-8. doi: 10.1038/nature11042.'}, {'pmid': '25616438', 'type': 'BACKGROUND', 'citation': 'Wang X, Hjorth E, Vedin I, Eriksdotter M, Freund-Levi Y, Wahlund LO, Cederholm T, Palmblad J, Schultzberg M. Effects of n-3 FA supplementation on the release of proresolving lipid mediators by blood mononuclear cells: the OmegAD study. J Lipid Res. 2015 Mar;56(3):674-681. doi: 10.1194/jlr.P055418. Epub 2015 Jan 23.'}, {'pmid': '24692596', 'type': 'BACKGROUND', 'citation': 'Recchiuti A, Codagnone M, Pierdomenico AM, Rossi C, Mari VC, Cianci E, Simiele F, Gatta V, Romano M. Immunoresolving actions of oral resolvin D1 include selective regulation of the transcription machinery in resolution-phase mouse macrophages. FASEB J. 2014 Jul;28(7):3090-102. doi: 10.1096/fj.13-248393. Epub 2014 Apr 1.'}, {'pmid': '16847262', 'type': 'BACKGROUND', 'citation': 'Hudert CA, Weylandt KH, Lu Y, Wang J, Hong S, Dignass A, Serhan CN, Kang JX. Transgenic mice rich in endogenous omega-3 fatty acids are protected from colitis. Proc Natl Acad Sci U S A. 2006 Jul 25;103(30):11276-81. doi: 10.1073/pnas.0601280103. Epub 2006 Jul 17.'}, {'pmid': '25674025', 'type': 'BACKGROUND', 'citation': 'Alie N, Eldib M, Fayad ZA, Mani V. Inflammation, Atherosclerosis, and Coronary Artery Disease: PET/CT for the Evaluation of Atherosclerosis and Inflammation. Clin Med Insights Cardiol. 2015 Jan 7;8(Suppl 3):13-21. doi: 10.4137/CMC.S17063. eCollection 2014.'}, {'pmid': '18483100', 'type': 'BACKGROUND', 'citation': 'Rudd JH, Myers KS, Bansilal S, Machac J, Pinto CA, Tong C, Rafique A, Hargeaves R, Farkouh M, Fuster V, Fayad ZA. Atherosclerosis inflammation imaging with 18F-FDG PET: carotid, iliac, and femoral uptake reproducibility, quantification methods, and recommendations. J Nucl Med. 2008 Jun;49(6):871-8. doi: 10.2967/jnumed.107.050294. Epub 2008 May 15.'}, {'pmid': '27639759', 'type': 'BACKGROUND', 'citation': 'van der Valk FM, Verweij SL, Zwinderman KA, Strang AC, Kaiser Y, Marquering HA, Nederveen AJ, Stroes ES, Verberne HJ, Rudd JH. Thresholds for Arterial Wall Inflammation Quantified by 18F-FDG PET Imaging: Implications for Vascular Interventional Studies. JACC Cardiovasc Imaging. 2016 Oct;9(10):1198-1207. doi: 10.1016/j.jcmg.2016.04.007. Epub 2016 Sep 14.'}, {'pmid': '12595841', 'type': 'BACKGROUND', 'citation': 'Almagor M, Keren A, Banai S. Increased C-reactive protein level after coronary stent implantation in patients with stable coronary artery disease. Am Heart J. 2003 Feb;145(2):248-53. doi: 10.1067/mhj.2003.16.'}]}, 'descriptionModule': {'briefSummary': 'This study evaluates the local inflammatory and resolution response of patients undergoing peripheral vascular intervention like an angioplasty of the superficial femoral artery (SFA) or popliteal artery, or stenting of the iliac artery or SFA, through the use of Positron emission tomography-magnetic resonance imaging (PET/MRI). PET/MRI will be performed prior to intervention, one day and one week after intervention.', 'detailedDescription': 'Magnetic resonance imaging (MRI) imaging allows for non-invasive visualization of anatomical structures while Positron emission tomography (PET) scans allow for the observation of molecular and cellular activities. Using a PET/MRI in patients with vascular injury post intervention with help evaluate the vascular inflammatory and resolution response in vivo.\n\nAcute vascular injury through endovascular intervention results in recruitment of inflammatory cells such as macrophages to the vessel wall. Macrophages are very metabolically active and consume glucose at a high rate. In PET/MRI, subjects are injected with 18F-Fluorodeoxyglucose (18F-FDG), a radioactively labeled glucose molecule which is consumed by macrophages.\n\nWhen 18F-FDG is consumed, it is retained within macrophages more avidly than other atherosclerotic lesion elements. Thus, FDG-PET provides a unique and noninvasive approach to quantitatively measure macrophage activity at the intervention site.\n\nThis study will provide key pilot data for developing an imaging surrogate endpoint for pro-resolving mediator treatment intervention trials going forward.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Over the age of 40,\n* With resting or exercise ABI \\<0.9, TBI \\<0.6\n* Have claudication or limb threatening ischemia \\& planning to undergo a percutaneous angioplasty of SFA or popliteal artery, or stenting of the iliac artery or SFA.\n\nExclusion Criteria:\n\n* Evidence of active infection\n* Hypersensitivity or allergy to contrast agents\n* Chronic liver disease, renal disease (GFR\\< 30) or chronic inflammatory disorders\n* Insulin dependent diabetes\n* Presence of metal within subject's body, pacemakers, or defibrillators\n* BMI \\< 20 or \\>35\n* Recent other major surgery or illness within 30 days\n* Use of immunosuppressive medications or steroids\n* History of organ transplantation\n* Pregnancy, or plans to become pregnant, or lactating"}, 'identificationModule': {'nctId': 'NCT03590769', 'acronym': 'AIIRES', 'briefTitle': 'Arterial Imaging of Inflammation and Resolution After Endovascular Surgery', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Francisco'}, 'officialTitle': 'Arterial Imaging of Inflammation and Resolution After Endovascular Surgery', 'orgStudyIdInfo': {'id': '16-21018'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PET/MR using FDG-18 radiotracer', 'description': 'Using FDG-18 radiotracer, subject undergoes PET/MR scan which detects the uptake of the tracer.', 'interventionNames': ['Drug: 18F-FDG']}], 'interventions': [{'name': '18F-FDG', 'type': 'DRUG', 'description': 'All subject will undergo PET/MRI scans pre-operatively, 1 day and 1 week post-operatively using FDG', 'armGroupLabels': ['PET/MR using FDG-18 radiotracer']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94110', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'San Francisco General Hospital', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '94143', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'UCSF', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}], 'overallOfficials': [{'name': 'Michael S Conte, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}, {'name': 'Miguel H Pampaloni, M.D., PhD.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Francisco', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}