Ignite Creation Date:
2025-12-25 @ 1:31 AM
Ignite Modification Date:
2026-01-07 @ 4:49 AM
Study NCT ID:
NCT02428894
Status:
COMPLETED
Last Update Posted:
2017-07-17
First Post:
2015-04-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Characterization of the Plasma Proteome Following Left Ventricular Assist Device Implantation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018487', 'term': 'Ventricular Dysfunction, Left'}], 'ancestors': [{'id': 'D018754', 'term': 'Ventricular Dysfunction'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Change in plasma proteins. \\[Time Frame, Days 7, 14, 30, 60, 90, and 180 post-LVAD implantation\\]\\[Designated as safety issue: No\\]'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-07-14', 'studyFirstSubmitDate': '2015-04-17', 'studyFirstSubmitQcDate': '2015-04-23', 'lastUpdatePostDateStruct': {'date': '2017-07-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-04-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quantitative differences in plasma protein abundance', 'timeFrame': 'Days 7, 14, 30, 60, 90, and 180 post-LVAD implantation'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Ventricular Dysfunction, Left']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to characterize changes in the plasma proteome over time following left ventricular assist device (LVAD) implantation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '21 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Study participants will be recruited from the University of Colorado Hospital Advanced Heart Failure Program.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Planned HeartMate II LVAD implantation\n* Planned warfarin (goal INR, 2.0-3.0) and low-dose aspirin therapy post-LVAD placement\n\nExclusion Criteria:\n\n* Prior history of mechanical circulatory support;\n* Body weight \\< 110 lbs;\n* Pre-existing hemolytic, bleeding, or immunologic disorders prior to LVAD implantation;\n* Severe aortic stenosis;\n* Renal failure requiring dialysis;\n* Hepatic dysfunction resulting in severe coagulopathies;\n* Recent serious infection;\n* Current need for prolonged ventilatory support;\n* Prior organ transplantation;\n* Blood transfusion within 14 days of the first planned study blood draw;\n* Concomitant immunosuppressant or chemotherapeutic agents;\n* Pregnant women;\n* Decisionally challenged or prisoners;\n* Unwilling to provide written informed consent'}, 'identificationModule': {'nctId': 'NCT02428894', 'briefTitle': 'Characterization of the Plasma Proteome Following Left Ventricular Assist Device Implantation', 'organization': {'class': 'OTHER', 'fullName': 'University of Colorado, Denver'}, 'officialTitle': 'Characterization of the Plasma Proteome Following Left Ventricular Assist Device Implantation', 'orgStudyIdInfo': {'id': '14-1376'}, 'secondaryIdInfos': [{'id': '14GRNT20380495', 'type': 'OTHER_GRANT', 'domain': 'American Heart Association'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'LVAD recipients', 'interventionNames': ['Device: LVAD']}], 'interventions': [{'name': 'LVAD', 'type': 'DEVICE', 'otherNames': ['HeartMate II'], 'armGroupLabels': ['LVAD recipients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado Anschutz Medical Campus', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}], 'overallOfficials': [{'name': 'Christina Aquilante, Pharm.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Colorado, Denver'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Colorado, Denver', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}