Ignite Creation Date:
2025-12-24 @ 10:09 PM
Ignite Modification Date:
2026-03-06 @ 5:57 PM
Study NCT ID:
NCT02193035
Status:
COMPLETED
Last Update Posted:
2016-04-13
First Post:
2014-07-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Microparticles in Severe Aortic Stenosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001024', 'term': 'Aortic Valve Stenosis'}], 'ancestors': [{'id': 'D000082862', 'term': 'Aortic Valve Disease'}, {'id': 'D006349', 'term': 'Heart Valve Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014694', 'term': 'Ventricular Outflow Obstruction'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'completionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-04-12', 'studyFirstSubmitDate': '2014-07-11', 'studyFirstSubmitQcDate': '2014-07-15', 'lastUpdatePostDateStruct': {'date': '2016-04-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-07-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Difference in microparticle levels', 'timeFrame': 'Day 5', 'description': 'Difference of total microparticle levels before and after treatment of patients with percutaneous aortic valve replacement'}], 'secondaryOutcomes': [{'measure': 'Endothelial microparticle levels', 'timeFrame': 'Day 5', 'description': 'Difference of endothelial microparticle levels before and after treatment of patients with percutaneous aortic valve replacement'}, {'measure': 'Macrophage microparticle levels', 'timeFrame': 'Day 5', 'description': 'Difference of macrophage microparticle levels before and after treatment of patients with percutaneous aortic valve replacement'}, {'measure': 'Platelet microparticle levels', 'timeFrame': 'Day 5', 'description': 'Difference of platelet microparticle levels before and after treatment of patients with percutaneous aortic valve replacement'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Microparticles', 'Severe aortic stenosis', 'Calcified aortic stenosis', 'transcatheter aortic valve replacement'], 'conditions': ['Aortic Valve Stenosis']}, 'referencesModule': {'references': [{'pmid': '27063005', 'type': 'RESULT', 'citation': 'Marchini JF, Miyakawa AA, Tarasoutchi F, Krieger JE, Lemos P, Croce K. Endothelial, platelet, and macrophage microparticle levels do not change acutely following transcatheter aortic valve replacement. J Negat Results Biomed. 2016 Apr 11;15:7. doi: 10.1186/s12952-016-0051-2.'}]}, 'descriptionModule': {'briefSummary': 'Microparticles are small cell fragments that can induce fat plaques, calcification and formation of thrombus. They can be released through multiple stimulations, but also the high flow of blood through partially obstructed aortic valves.\n\nIn patients with severely obstructed aortic valves the investigators hypothesize that microparticles levels will be elevated and that they will go down after percutaneous treatment of the valves.', 'detailedDescription': 'Microparticle (MPs) levels and subtypes according to endothelial cell, macrophage and platelet markers will be measured by flow-cytometry using appropriate fluorochromes. Patient baseline (including measures of severity of aortic stenosis and its calcification), procedural data, and clinical evolution will be collected. Inflammatory markers will be measured, which along with clinical date will be tested for correlation with microparticle levels.\n\nPatients MPs will be measured before and after percutaneous treatment of the severe aortic stenosis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical indication to be treated with transcatheter aortic valve replacement.\n\nExclusion Criteria:\n\n* Non native aortic valve\n* Moderate aortic regurgitation\n* The following complications following valve implantation: patient instability, need for vasoactive pressors, sepsis and severe infections, stroke.'}, 'identificationModule': {'nctId': 'NCT02193035', 'briefTitle': 'Microparticles in Severe Aortic Stenosis', 'organization': {'class': 'OTHER', 'fullName': 'InCor Heart Institute'}, 'officialTitle': 'Microparticles as an Inflammatory Marker in Severe Aortic Stenosis.', 'orgStudyIdInfo': {'id': '31446114.1.0000.0068'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Single group', 'description': 'Patients with severe aortic stenosis treated with transcatheter aortic valve replacement (TAVR). Microparticle levels will be measured before and after TAVR.', 'interventionNames': ['Other: Microparticle levels']}], 'interventions': [{'name': 'Microparticle levels', 'type': 'OTHER', 'description': 'Microparticle levels will be evaluated with flow cytometry and nanoparticle tracking analysis', 'armGroupLabels': ['Single group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '05403-000', 'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Heart Institute - InCor. University of Sao Paulo Medical School', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'overallOfficials': [{'name': 'Pedro Lemos, MD PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Heart Institute - InCor. University of Sao Paulo Medical School'}, {'name': 'Julio F Marchini, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Heart Institute - InCor. University of Sao Paulo Medical School'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'InCor Heart Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Medicine', 'investigatorFullName': 'Pedro A. Lemos', 'investigatorAffiliation': 'InCor Heart Institute'}}}}