Ignite Creation Date:
2025-12-25 @ 12:10 AM
Ignite Modification Date:
2025-12-25 @ 10:10 PM
Study NCT ID:
NCT00143858
Status:
COMPLETED
Last Update Posted:
2009-08-11
First Post:
2005-08-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Assessment of the Clinical Utility of Non Invasive Peripheral Signal Averaged Pulse Volume
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'ECOLOGIC_OR_COMMUNITY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-08', 'completionDateStruct': {'date': '2007-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-08-06', 'studyFirstSubmitDate': '2005-08-31', 'studyFirstSubmitQcDate': '2005-09-01', 'lastUpdatePostDateStruct': {'date': '2009-08-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-02', 'type': 'ESTIMATED'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Peripheral Pulse Volume'], 'conditions': ['Peripheral Vascular Response']}, 'referencesModule': {'references': [{'pmid': '3570309', 'type': 'BACKGROUND', 'citation': 'Marks LA. Digital enhancement of the peripheral admittance plethysmogram. IEEE Trans Biomed Eng. 1987 Mar;34(3):192-8. doi: 10.1109/tbme.1987.325944. No abstract available.'}]}, 'descriptionModule': {'briefSummary': "The purpose of this study is to determine the clinical usefulness of measuring the heart's pumping ability by measuring the Peripheral Pulse Volume (PPV).", 'detailedDescription': "Peripheral Pulse Volume (PPV) is the change in the volume of a limb that occurs when blood passes through the limb. The limb also acts as an electrical conductor whose electrical impedence changes with limb geometry and volume. Each time the heart beats, the volume of the limb segment changes, and therefore its electrical impedence changes. A plethysmograph can be used to measure volume changes of a part of the body by producing a plethysmographic waveform. Selectively capturing a number of these plethysmographic wave forms with acceptable noise levels and averaging them using the EKG as a reference-timing signal generate a highly reproducible pulse volume signal. Signal averaged pulse volume measurement will be obtained non-invasively from the lower extremities of patient volunteers. A disposal non-occluding electrical monitoring strap will be applied to the calf of each patient. Changes in the calf's size/volume caused by changes in the patient's cardiac output and calf blood flow will result in electrical impedance changes. These changes will be recorded by an analog admittance plethysmograph attached to the lower extremity strap. The analog plethysmograph is coupled to a digital computer for signal enhancement and measurement."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patient who are having a right heart catherization done for other diagnostic purposes or patient in the critical care units who have Swan Ganz catheters in place for other medical management', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\n* Coronary care unit patients with indwelling right heart (Swan Ganz) catheters with or without intraaortic balloon assist pumping devices.\n* Congestive Heart Failure patients on and off various therapeutic inotropic agents with or without indwelling heart catheters\n* Cardiac catheterization laboratory patients undergoing prophylactic IABP in the presence of left main or diffuse unstable CAD\n* Chronic renal failure patients undergoing hemodialysis.\n* Peripheral Vascular Disease patients\n* Patients undergoing Tilt Table Testing\n* Any patients undergoing right heart catheterization Exclusion criteria -- Non specified'}, 'identificationModule': {'nctId': 'NCT00143858', 'briefTitle': 'Assessment of the Clinical Utility of Non Invasive Peripheral Signal Averaged Pulse Volume', 'organization': {'class': 'OTHER', 'fullName': 'Rutgers, The State University of New Jersey'}, 'officialTitle': 'Assessment of the Clinical Utility of Non Invasive Peripheral Signal Averaged Pulse Volume', 'orgStudyIdInfo': {'id': '4301'}, 'secondaryIdInfos': [{'id': 'investigator initiated'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Pulse Volume Measurement', 'type': 'DEVICE', 'description': 'patients will wear a newly designed calf monitor that will be hooked up to a computer that will monitor leg peripheral pulse volumes which will then be correlated to pressures obtained with Swan Ganz monitoring. The calf monitor is gut two bands with sensors that are wrapped around the ankle and below the knww'}]}, 'contactsLocationsModule': {'locations': [{'zip': '08901', 'city': 'New Brunswick', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Robert Wood Johnson University Hospital', 'geoPoint': {'lat': 40.48622, 'lon': -74.45182}}], 'overallOfficials': [{'name': 'Sebastian Palmeri, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rutgers, The State University of New Jersey'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Medicine and Dentistry of New Jersey', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Sebastian T. Palmeri, MD -- Principal Investigator', 'oldOrganization': 'UMDNJ-Robert Wood Johnson Medical School'}}}}