Ignite Creation Date:
2025-12-25 @ 12:37 AM
Ignite Modification Date:
2026-03-03 @ 9:15 PM
Study NCT ID:
NCT01926067
Status:
COMPLETED
Last Update Posted:
2015-03-02
First Post:
2012-06-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Monitoring of Cardiac Function With 3-axis Accelerometers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-02', 'completionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-02-27', 'studyFirstSubmitDate': '2012-06-19', 'studyFirstSubmitQcDate': '2013-08-19', 'lastUpdatePostDateStruct': {'date': '2015-03-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-08-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison of global heart function measures between accelerometer, echocardiography and hemodynamics.', 'timeFrame': 'The patients will be followed during surgery, approximately 3 hours.', 'description': "Measures will be assessed at baseline before cardiopulmonary by pass, at different workloads during a stepwise weaning, and after the cannulas are removed. The accelerometer measurements will be compared to echocardiography and hemodynamics (stroke volume and cardiac output). Systolic global function will be assessed by comparing peak systolic velocity and displacement by the accelerometer and the corresponding findings in echocardiography. The accelerometer systolic measures will also be correlated to ejection fraction with echocardiography. Diastolic global function early inflow (E'), atrial inflow velocity (A') and E'/A' with accelerometers and echocardiography will be compared."}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Accelerometer', 'Cardiopulmonary by pass'], 'conditions': ['Heart; Surgery, Heart, Functional Disturbance as Result']}, 'referencesModule': {'references': [{'pmid': '28364479', 'type': 'DERIVED', 'citation': 'Grymyr OH, Beitnes JO, Eidet J, Tollofsrud S, Fiane A, Skulstad H, Fosse E, Halvorsen PS. Detection of intraoperative myocardial dysfunction by accelerometer during aortic valve replacement. Interact Cardiovasc Thorac Surg. 2017 Feb 1;24(2):188-195. doi: 10.1093/icvts/ivw326.'}]}, 'descriptionModule': {'briefSummary': 'Aim of the study: To validate accelerometers for continuous monitoring of global cardiac function during weaning from cardiopulmonary bypass (CPB) in cardiac surgery.', 'detailedDescription': 'Hypothesis:\n\nThe following hypothesis will be tested: Accelerometer measures are clinical relevant indices of global left and right myocardial performance during weaning from cardiopulmonary bypass.\n\nModel:\n\nThe performance of the accelerometer will be tested in a intraoperative setting, during weaning from cardiopulmonary bypass. Accelerometer measures of ventricular systolic and diastolic function will be compared to corresponding measures and indices of ventricular functions by echocardiography and hemodynamic monitoring during a step wise controlled weaning from cardiopulmonary bypass, ensuring precise control of pre- and afterload.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with significant aortic stenosis scheduled for surgical AVR', 'healthyVolunteers': False, 'eligibilityCriteria': 'The hypothesis will be tested in 20 elective patients.\n\nInclusion Criteria:\n\n* Significant aortic valvular disease scheduled to undergo cardiac surgery with an estimated extracorporeal circulation time \\> 40 min.\n\nExclusion Criteria:\n\n* Evolving myocardial infarction,\n* dyskinetic wall motions,\n* cardiogenic shock,\n* hepatic dysfunction or esophageal disease.'}, 'identificationModule': {'nctId': 'NCT01926067', 'briefTitle': 'Monitoring of Cardiac Function With 3-axis Accelerometers', 'organization': {'class': 'OTHER', 'fullName': 'Oslo University Hospital'}, 'officialTitle': 'Monitoring of Cardiac Function With 3-axis Accelerometers During Weaning of Cardiopulmonary by Pass After Heart Surgery', 'orgStudyIdInfo': {'id': '2011/2305 A (REK)'}}, 'contactsLocationsModule': {'locations': [{'zip': '0027', 'city': 'Oslo', 'country': 'Norway', 'facility': 'Oslo University Hospital, The Intervention Sentre', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}], 'overallOfficials': [{'name': 'Erik Fosse, Professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Oslo University Hospital, The Intervention Sentre'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oslo University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Oslo', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}