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Evaluation of Left Ventricular Function by Speckle Tracking Echocardiography in Patient Hospitalised in Intensive Care Unit for Vaso-occlusive Crisis

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ClinicalTrials.gov Identifier: NCT04864041
Recruitment Status : Recruiting
First Posted : April 28, 2021
Last Update Posted : April 29, 2021
Sponsor:
Information provided by (Responsible Party):
Xavier Monnet, Bicetre Hospital

Brief Summary:
Vaso-occlusive crisis in Sickle cell disease might alter myocardial function through micro vascular obstruction. Evaluation of strain alteration using speckle tracking echocardiography is a non invasive technique that may allow us to observe such myocardial dysfunction. No such study has yet been conducted in patient hospitalised in intensive care unit. Our hypothesis is that strain alteration during vaso-occlusive crisis, if they do exist, can be correlated with other markers of myocardial injury such as troponin level or thoracic pain.

Condition or disease Intervention/treatment
Sickle Cell Disease Other: Evaluation of global longitudinal strain using routinely recorded echocardiography images

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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Left Ventricular Function by Speckle Tracking Echocardiography in Patient Hospitalised in Intensive Care Unit for Vaso-occlusive Crisis
Actual Study Start Date : January 1, 2021
Estimated Primary Completion Date : December 1, 2023
Estimated Study Completion Date : December 1, 2023

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Patients hospitalised in ICU for vaso-occlusive crisis Other: Evaluation of global longitudinal strain using routinely recorded echocardiography images
There are no particular intervention performed in patients in this study, because echocardiography is part of the standard of care of patients hospitalised in the ICU for vaso occlusive crisis.




Primary Outcome Measures :
  1. Global longitudinal strain [ Time Frame: Day 0 ]
    Measure of global longitudinal strain using speckle tracking echocardiography

  2. Global longitudinal strain [ Time Frame: Day 1 ]
    Measure of global longitudinal strain using speckle tracking echocardiography

  3. Global longitudinal strain [ Time Frame: Day 2 ]
    Measure of global longitudinal strain using speckle tracking echocardiography


Secondary Outcome Measures :
  1. Troponine level [ Time Frame: Day 0 ]
  2. Troponine level [ Time Frame: Day 1 ]
  3. Troponine level [ Time Frame: Day 2 ]
  4. Electrocardiogram QT interval [ Time Frame: Day 0 ]
  5. Electrocardiogram QT interval [ Time Frame: Day 2 ]
  6. Electrocardiogram ST elevation [ Time Frame: Day 0 ]
  7. Electrocardiogram ST elevation [ Time Frame: Day 2 ]
  8. Electrocardiogram negative T waves [ Time Frame: Day 0 ]
  9. Electrocardiogram negative T waves [ Time Frame: Day 2 ]
  10. Thoracic pain [ Time Frame: Day 0 ]
    Numerical rating scale from 0 to 10 assessed by the patient

  11. Thoracic pain [ Time Frame: Day 1 ]
    Numerical rating scale from 0 to 10 assessed by the patient

  12. Thoracic pain [ Time Frame: Day 2 ]
    Numerical rating scale from 0 to 10 assessed by the patient



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patient with vaso occlusive crisis hospitalised in an intensive care unit.
Criteria

Inclusion Criteria:

  • Hospitalisation in an intensive care unit for vaso-occlusive crisis

Exclusion Criteria:

  • Pregnancy
  • Individuals under guardianship
  • Unsufficient echogenicity
  • Thoracic pain prohibiting echocardiography assessment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04864041


Contacts
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Contact: Xavier Monnet, MD, PhD 00331 45 21 35 39 xavier.monnet@aphp.fr

Locations
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France
Medical Intensive Care Unit Recruiting
Le Kremlin-Bicêtre, France
Contact: Xavier Monnet, MD, PhD    00331 45 21 35 39    xavier.monnet@aphp.fr   
Principal Investigator: Xavier Monnet, MD, PhD         
Sponsors and Collaborators
Bicetre Hospital
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Responsible Party: Xavier Monnet, Clinical Professor, Bicetre Hospital
ClinicalTrials.gov Identifier: NCT04864041    
Other Study ID Numbers: 2021-A00623-38
First Posted: April 28, 2021    Key Record Dates
Last Update Posted: April 29, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Xavier Monnet, Bicetre Hospital:
ICU Intensive Care Units
Transthoracic Echocardiography
Left Ventricular Function
Additional relevant MeSH terms:
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Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn