Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
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


Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Layout table for location contacts
Contact: Xavier Monnet, MD, PhD 00331 45 21 35 39 xavier.monnet@aphp.fr

Locations
Layout table for location information
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
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
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

Layout table for additional information
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:
Layout table for MeSH terms
Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
 Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn