Ignite Creation Date:
2025-12-24 @ 11:49 PM
Ignite Modification Date:
2025-12-25 @ 9:43 PM
Study NCT ID:
NCT04322851
Status:
UNKNOWN
Last Update Posted:
2023-02-02
First Post:
2020-02-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
B-line by Lung US in Patients With Acute Decompensated Heart Failure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2025-08-14', 'releaseDate': '2025-07-30'}], 'estimatedResultsFirstSubmitDate': '2025-07-30'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2024-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-02-01', 'studyFirstSubmitDate': '2020-02-26', 'studyFirstSubmitQcDate': '2020-03-25', 'lastUpdatePostDateStruct': {'date': '2023-02-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Re-intubation rate', 'timeFrame': 'within 72 hours from initial extubation'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Heart Failure']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate that B-line detected by lung ultrasound before extubation in patients with acute decompensated heart failure can predict future risk of reintubation and clinical outcomes during admission in Korea.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects who are on mechanical ventilation due to acute heart failure', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* mechanical ventilation due to acute heart failure\n\nExclusion Criteria:\n\n* none'}, 'identificationModule': {'nctId': 'NCT04322851', 'briefTitle': 'B-line by Lung US in Patients With Acute Decompensated Heart Failure', 'organization': {'class': 'OTHER', 'fullName': 'Asan Medical Center'}, 'officialTitle': 'Implication of B-line Estimated by Lung Ultrasound on Risk of Reintubation in Mechanically Ventilated Patients With Acute Decompensated Heart Failure', 'orgStudyIdInfo': {'id': 'AMC_2020_0164'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'B-line positive', 'interventionNames': ['Diagnostic Test: Lung ultrasound']}, {'label': 'B-line negative', 'interventionNames': ['Diagnostic Test: Lung ultrasound']}], 'interventions': [{'name': 'Lung ultrasound', 'type': 'DIAGNOSTIC_TEST', 'description': 'Lung ultrasound performed at the time of extubation to evaluate B-line in patients with mechanical ventilation due to acute decompensated heart failure', 'armGroupLabels': ['B-line negative', 'B-line positive']}]}, 'contactsLocationsModule': {'locations': [{'zip': '05505', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Min Seok Kim, PhD', 'role': 'CONTACT', 'email': 'guess124@gmail.com', 'phone': '02-3010-3948'}, {'name': 'Junho Hyun, MD', 'role': 'CONTACT', 'email': 'jhhyun0609@gmail.com', 'phone': '02-3010-0055'}], 'facility': 'Asan Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Minseok Kim', 'role': 'CONTACT', 'email': 'msk@amc.seoul.kr', 'phone': '(82-2)-3010-3948'}], 'overallOfficials': [{'name': 'Minseok Kim', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Asan Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Asan Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'professor of medicine', 'investigatorFullName': 'Min-Seok Kim', 'investigatorAffiliation': 'Asan Medical Center'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2025-07-30', 'type': 'RELEASE'}, {'date': '2025-08-14', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Min-Seok Kim, professor of medicine, Asan Medical Center'}}}}