Strain Analysis as a Right Ventricle Contractility Marker
30 oktober 2019 bijgewerkt door: Hospices Civils de Lyon
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.
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Werkelijk)
16
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
-
-
-
Lyon, Frankrijk, 69004
- Hôpital de la Croix Rousse
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Lyon, Frankrijk, 69007
- Hopital Saint Joseph Saint Luc
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-
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar en ouder (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
Inclusion Criteria:
- Male or female ≥ 18 years
- Patients with renal failure treated with intermittent hemodialysis
- 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.
Exclusion Criteria:
- Patients with heart disease (valvular, ischemic, rhythmic)
- Patients with ejection fraction of left ventricular altered <45%
- Chronic dialysis patients
Patients referred in Articles L. 1121-5, L.1121-6, L.1121-7, L.1121-8 of the Public Health Code:
- Pregnant women, parturients or nursing mothers
- 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
- Minor Patients
- Major persons who are subject to a legal protection measure or are unable to express their consent
- Patients not willing to participate in the study
- Patients not affiliated to a social security
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Diagnostisch
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Ander: ultrasound measurements
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.
|
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
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Evaluation of the change in the Longitudinal strain of the free wall right ventricle
Tijdsspanne: at baseline, 1 minute after starting hemodialysis, 1 hour after, and 5 minutes before restitution
|
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
|
at baseline, 1 minute after starting hemodialysis, 1 hour after, and 5 minutes before restitution
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Evaluation of the change in S' right ventricle wave
Tijdsspanne: at baseline, 1 minute after starting hemodialysis, 1 hour after, and 5 minutes before restitution
|
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
|
at baseline, 1 minute after starting hemodialysis, 1 hour after, and 5 minutes before restitution
|
|
Evaluation of the change in tricuspid annular plane systolic excursion (TAPSE)
Tijdsspanne: at baseline, 1 minute after starting hemodialysis, 1 hour after, and 5 minutes before restitution
|
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
|
at baseline, 1 minute after starting hemodialysis, 1 hour after, and 5 minutes before restitution
|
|
Evaluation of the change in visual left ventricular ejection fraction (LVEF)
Tijdsspanne: at baseline, 1 minute after starting hemodialysis, 1 hour after, and 5 minutes before restitution
|
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
|
at baseline, 1 minute after starting hemodialysis, 1 hour after, and 5 minutes before restitution
|
|
Evaluation of the change in mitral E wave
Tijdsspanne: at baseline, 1 minute after starting hemodialysis, 1 hour after, and 5 minutes before restitution
|
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
|
at baseline, 1 minute after starting hemodialysis, 1 hour after, and 5 minutes before restitution
|
|
Evaluation of the change in mitral A wave
Tijdsspanne: at baseline, 1 minute after starting hemodialysis, 1 hour after, and 5 minutes before restitution
|
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
|
at baseline, 1 minute after starting hemodialysis, 1 hour after, and 5 minutes before restitution
|
|
Evaluation of the change in wave E ' at the lateral mitral ring
Tijdsspanne: at baseline, 1 minute after starting hemodialysis, 1 hour after, and 5 minutes before restitution
|
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
|
at baseline, 1 minute after starting hemodialysis, 1 hour after, and 5 minutes before restitution
|
|
Evaluation of the change in systolic fraction of pulmonary venous flow
Tijdsspanne: at baseline, 1 minute after starting hemodialysis, 1 hour after, and 5 minutes before restitution
|
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
|
at baseline, 1 minute after starting hemodialysis, 1 hour after, and 5 minutes before restitution
|
|
inter individual variability of Longitudinal strain of the free wall right ventricle
Tijdsspanne: at baseline, 1 minute after starting hemodialysis, 1 hour after, and 5 minutes before restitution
|
Each measurement will be performed by two blind operators
|
at baseline, 1 minute after starting hemodialysis, 1 hour after, and 5 minutes before restitution
|
|
intra individual variability of Longitudinal strain of the free wall right ventricle
Tijdsspanne: at baseline, 1 minute after starting hemodialysis, 1 hour after, and 5 minutes before restitution
|
Each measurement will be performed by two blind operators
|
at baseline, 1 minute after starting hemodialysis, 1 hour after, and 5 minutes before restitution
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Onderzoekers
- Hoofdonderzoeker: Zoé Schmitt, Hopital de la Croix-Rousse
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
25 november 2016
Primaire voltooiing (Werkelijk)
31 december 2017
Studie voltooiing (Werkelijk)
31 december 2017
Studieregistratiedata
Eerst ingediend
10 maart 2017
Eerst ingediend dat voldeed aan de QC-criteria
20 maart 2017
Eerst geplaatst (Werkelijk)
24 maart 2017
Updates van studierecords
Laatste update geplaatst (Werkelijk)
31 oktober 2019
Laatste update ingediend die voldeed aan QC-criteria
30 oktober 2019
Laatst geverifieerd
1 oktober 2019
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 69HCL16-0370
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .