Ignite Creation Date:
2025-12-24 @ 3:06 PM
Ignite Modification Date:
2025-12-26 @ 3:42 AM
Study NCT ID:
NCT01264159
Status:
TERMINATED
Last Update Posted:
2020-06-11
First Post:
2010-12-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Preemptive Lung Impedance-guided Therapy of Evolving Acute Heart Failure in Acute Myocardial Infarction Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}}, 'statusModule': {'whyStopped': 'The principle investigator decided to change the protocol', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2011-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2015-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-06-10', 'studyFirstSubmitDate': '2010-12-20', 'studyFirstSubmitQcDate': '2010-12-20', 'lastUpdatePostDateStruct': {'date': '2020-06-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-12-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prevention of acute heart failure development in acute MI patients', 'timeFrame': 'Three years'}], 'secondaryOutcomes': [{'measure': 'Improvement of clinical outcome in patients with lung impedence-guided treatments', 'timeFrame': 'Three years'}]}, 'conditionsModule': {'keywords': ['Developing acute heart failure'], 'conditions': ['Acute Heart Failure']}, 'descriptionModule': {'briefSummary': 'It is well known that 20-25% of patients hospitalized for acute myocardial infarction will develop acute heart failure during their hospitalization. Currently, the investigators have no reliable parameter for prediction of evolving acute heart failure in such a group of patients. As a result, the investigators have no way of preventing acute heart failure. Treatment of these patients only begins after appearance of clinical signs of acute heart failure. Lung impedance monitoring may be a good non-invasive parameter for prediction of evolving acute heart failure. This study will attempt to address whether preemptive lung impedence-guided therapy may prevent the development of overt acute heart failure and improve their clinical outcome.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients hospitalized in the ICCU for acute myocardial infarction and developing acute heart failure during their hospitalization\n\nExclusion Criteria:\n\n* Patients with acute myocardial infarction with clinical and radiological signs of acute heart failure at admission'}, 'identificationModule': {'nctId': 'NCT01264159', 'briefTitle': 'Preemptive Lung Impedance-guided Therapy of Evolving Acute Heart Failure in Acute Myocardial Infarction Patients', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Hillel Yaffe Medical Center'}, 'orgStudyIdInfo': {'id': '0090-10-HYMC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'interventionNames': ['Other: Usual treatment of patients with developing acute heart failure']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Lung impedence-guided treatment', 'interventionNames': ['Device: Lung impedence-guided therapy']}], 'interventions': [{'name': 'Lung impedence-guided therapy', 'type': 'DEVICE', 'armGroupLabels': ['Lung impedence-guided treatment']}, {'name': 'Usual treatment of patients with developing acute heart failure', 'type': 'OTHER', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '38100', 'city': 'Hadera', 'country': 'Israel', 'facility': 'Hillel Yaffe Medical Center', 'geoPoint': {'lat': 32.44192, 'lon': 34.9039}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hillel Yaffe Medical Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}