Ignite Creation Date:
2025-12-24 @ 7:55 PM
Ignite Modification Date:
2026-01-04 @ 8:28 PM
Study NCT ID:
NCT02951104
Status:
COMPLETED
Last Update Posted:
2022-03-10
First Post:
2016-10-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Noninvasive Cardiac Output Monitoring in Pulmonary Hypertension
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006976', 'term': 'Hypertension, Pulmonary'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016503', 'term': 'Drug Delivery Systems'}], 'ancestors': [{'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 35}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2021-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-08', 'studyFirstSubmitDate': '2016-10-27', 'studyFirstSubmitQcDate': '2016-10-28', 'lastUpdatePostDateStruct': {'date': '2022-03-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-11-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cardiac output measurement correlation at baseline', 'timeFrame': '30 minutes', 'description': 'Correlation between cardiac output measurement between USCOM system and Fick and thermodilution methods of cardiac output measurement (standard of care)'}], 'secondaryOutcomes': [{'measure': 'Cardiac output measurement correlation after vasodilator testing', 'timeFrame': '30 minutes', 'description': 'Correlation between cardiac output measurement between USCOM system and Fick and thermodilution methods of cardiac output measurement (standard of care) after vasodilator trial testing'}]}, 'conditionsModule': {'conditions': ['Pulmonary Hypertension']}, 'descriptionModule': {'briefSummary': 'Comparison of Ultrasonic Cardiac Output Monitor (USCOM) system with Fick and thermodilution methods during right heart catheterization in patients with pulmonary hypertension.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Age \\> 18 years\n* Diagnosis of Group 1 or Group 4 PAH based on PAPm \\> 25 mmHg, PAWP \\<15 mmHg, PVR \\>3 WU and consistent clinical history. Note: for logistical reasons, patients at high suspicion for Group 1 or Group 4 PAH will sign informed consent to have the USCOM system applied during right heart catheterization before the procedure; if it is found that the patient does not meet the definition of Group 1 or Group 4 PAH during right heart catheterization, he/she will be excluded.\n* Willingness and ability to comply with study procedures.\n* No known hypersensitivity to the components of USCOM electrodes\n\nExclusion criteria:\n\n* Unwillingness to sign informed consent or inability or unwillingness to comply with study procedures\n* Evidence of postcapillary pulmonary hypertension on right heart catheterization'}, 'identificationModule': {'nctId': 'NCT02951104', 'briefTitle': 'Noninvasive Cardiac Output Monitoring in Pulmonary Hypertension', 'organization': {'class': 'OTHER', 'fullName': 'Santa Barbara Cottage Hospital'}, 'officialTitle': 'Noninvasive Cardiac Output Monitoring in Pulmonary Hypertension', 'orgStudyIdInfo': {'id': '16-61'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'USCOM', 'interventionNames': ['Device: Ultrasonic Cardiac Output Monitor (USCOM) system']}], 'interventions': [{'name': 'Ultrasonic Cardiac Output Monitor (USCOM) system', 'type': 'DEVICE', 'armGroupLabels': ['USCOM']}]}, 'contactsLocationsModule': {'locations': [{'zip': '93105', 'city': 'Santa Barbara', 'state': 'California', 'country': 'United States', 'facility': 'Santa Barbara Cottage Hospital', 'geoPoint': {'lat': 34.42083, 'lon': -119.69819}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Santa Barbara Cottage Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}