Ignite Creation Date:
2025-12-24 @ 9:18 PM
Ignite Modification Date:
2026-01-04 @ 6:35 AM
Study NCT ID:
NCT03090204
Status:
COMPLETED
Last Update Posted:
2019-10-31
First Post:
2017-03-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Strain Analysis as a Right Ventricle Contractility Marker
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013180', 'term': 'Sprains and Strains'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-11-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2017-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-10-30', 'studyFirstSubmitDate': '2017-03-10', 'studyFirstSubmitQcDate': '2017-03-20', 'lastUpdatePostDateStruct': {'date': '2019-10-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of the change in the Longitudinal strain of the free wall right ventricle', 'timeFrame': 'at baseline, 1 minute after starting hemodialysis, 1 hour after, and 5 minutes before restitution', 'description': 'measurements will be performed using an ultrasound device usually used in our center for the hemodynamic monitoring of patients in intensive care by transthoracic cardiac ultrasound'}], 'secondaryOutcomes': [{'measure': "Evaluation of the change in S' right ventricle wave", 'timeFrame': 'at baseline, 1 minute after starting hemodialysis, 1 hour after, and 5 minutes before restitution', 'description': 'measurements will be performed using an ultrasound device usually used in our center for the hemodynamic monitoring of patients in intensive care by transthoracic cardiac ultrasound'}, {'measure': 'Evaluation of the change in tricuspid annular plane systolic excursion (TAPSE)', 'timeFrame': 'at baseline, 1 minute after starting hemodialysis, 1 hour after, and 5 minutes before restitution', 'description': 'measurements will be performed using an ultrasound device usually used in our center for the hemodynamic monitoring of patients in intensive care by transthoracic cardiac ultrasound'}, {'measure': 'Evaluation of the change in visual left ventricular ejection fraction (LVEF)', 'timeFrame': 'at baseline, 1 minute after starting hemodialysis, 1 hour after, and 5 minutes before restitution', 'description': 'measurements will be performed using an ultrasound device usually used in our center for the hemodynamic monitoring of patients in intensive care by transthoracic cardiac ultrasound'}, {'measure': 'Evaluation of the change in mitral E wave', 'timeFrame': 'at baseline, 1 minute after starting hemodialysis, 1 hour after, and 5 minutes before restitution', 'description': 'measurements will be performed using an ultrasound device usually used in our center for the hemodynamic monitoring of patients in intensive care by transthoracic cardiac ultrasound'}, {'measure': 'Evaluation of the change in mitral A wave', 'timeFrame': 'at baseline, 1 minute after starting hemodialysis, 1 hour after, and 5 minutes before restitution', 'description': 'measurements will be performed using an ultrasound device usually used in our center for the hemodynamic monitoring of patients in intensive care by transthoracic cardiac ultrasound'}, {'measure': "Evaluation of the change in wave E ' at the lateral mitral ring", 'timeFrame': 'at baseline, 1 minute after starting hemodialysis, 1 hour after, and 5 minutes before restitution', 'description': 'measurements will be performed using an ultrasound device usually used in our center for the hemodynamic monitoring of patients in intensive care by transthoracic cardiac ultrasound'}, {'measure': 'Evaluation of the change in systolic fraction of pulmonary venous flow', 'timeFrame': 'at baseline, 1 minute after starting hemodialysis, 1 hour after, and 5 minutes before restitution', 'description': 'measurements will be performed using an ultrasound device usually used in our center for the hemodynamic monitoring of patients in intensive care by transthoracic cardiac ultrasound'}, {'measure': 'inter individual variability of Longitudinal strain of the free wall right ventricle', 'timeFrame': 'at baseline, 1 minute after starting hemodialysis, 1 hour after, and 5 minutes before restitution', 'description': 'Each measurement will be performed by two blind operators'}, {'measure': 'intra individual variability of Longitudinal strain of the free wall right ventricle', 'timeFrame': 'at baseline, 1 minute after starting hemodialysis, 1 hour after, and 5 minutes before restitution', 'description': 'Each measurement will be performed by two blind operators'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['strain', 'myocarditic deformation imaging', 'right ventricle (RV)', 'systolic RV function', 'preload dependence', 'contractility', 'intermittent hemodialysis (HDI)'], 'conditions': ['Systolic Function']}, 'descriptionModule': {'briefSummary': 'The analysis of the systolic function (contractility) of the right ventricle (RV) is fundamental and central in many pathologies in intensive care unit. It can guide physicians in choosing therapeutics. The conventional ultrasound markers of RV function evaluation currently used are influenced by RV loading conditions, impairing their capacity to approximate a true contractility analysis. Myocardial strain imaging is a recent echographic technique that allows, among other things, to evaluate RV systolic function. It is a reproducible index with early variations which, if it proved to be independent pre-load, would help to better appreciate the RV contractility.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female ≥ 18 years\n* Patients with renal failure treated with intermittent hemodialysis\n* Patients who received an information and did not opposed to participate in the study, or, if unconscious patient at the time of inclusion: a person of trust as defined in Article L. 1111-6 of the Public Health Code, failing that, the family or, failing that, a person maintaining stable link, having received information and not opposed to participate in the study.\n\nExclusion Criteria:\n\n* Patients with heart disease (valvular, ischemic, rhythmic)\n* Patients with ejection fraction of left ventricular altered \\<45%\n* Chronic dialysis patients\n* Patients referred in Articles L. 1121-5, L.1121-6, L.1121-7, L.1121-8 of the Public Health Code:\n\n * Pregnant women, parturients or nursing mothers\n * Persons deprived of their liberty by a judicial or administrative decision, persons subject to psychiatric care, persons admitted to a health or social institution for purposes other than research\n * Minor Patients\n * Major persons who are subject to a legal protection measure or are unable to express their consent\n* Patients not willing to participate in the study\n* Patients not affiliated to a social security'}, 'identificationModule': {'nctId': 'NCT03090204', 'briefTitle': 'Strain Analysis as a Right Ventricle Contractility Marker', 'organization': {'class': 'OTHER', 'fullName': 'Hospices Civils de Lyon'}, 'officialTitle': 'Strain Analysis as a Right Ventricle Contractility Marker', 'orgStudyIdInfo': {'id': '69HCL16-0370'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'ultrasound measurements', 'description': 'ultrasound measurements of myocardial deformation of free wall right ventricle during a sharp decline of right ventricle preload induced during a session of Intermittent hemodialysis.', 'interventionNames': ['Procedure: ultrasound measurements']}], 'interventions': [{'name': 'ultrasound measurements', 'type': 'PROCEDURE', 'description': 'ultrasound measurements of myocardial deformation of free wall right ventricle at 4 time points during a session of intermittent hemodialysis : before the intermittent hemodialysis connection, just after starting hemodialysis, after 1 hour of hemodialysis and 5 minutes before restitution', 'armGroupLabels': ['ultrasound measurements']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69004', 'city': 'Lyon', 'country': 'France', 'facility': 'Hôpital de la Croix Rousse', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '69007', 'city': 'Lyon', 'country': 'France', 'facility': 'Hopital Saint Joseph Saint Luc', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}], 'overallOfficials': [{'name': 'Zoé Schmitt', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hôpital de la Croix-Rousse'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}