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

NCT04864041 | Unknown

• 1 other identifier: 2021-A00623-38
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Sickle Cell Disease

Keywords

ICU Intensive Care Units; Transthoracic Echocardiography; Left Ventricular Function

Outcome Measures

Primary Outcomes (3)

• Global longitudinal strain

  Measure of global longitudinal strain using speckle tracking echocardiography

  Day 0

• Global longitudinal strain

  Measure of global longitudinal strain using speckle tracking echocardiography

  Day 1

• Global longitudinal strain

  Measure of global longitudinal strain using speckle tracking echocardiography

  Day 2

Secondary Outcomes (12)

• Troponine level

  Day 0

• Troponine level

  Day 1

• Troponine level

  Day 2

• Electrocardiogram QT interval

  Day 0

• Electrocardiogram QT interval

  Day 2

Study Arms (1)

Patients hospitalised in ICU for vaso-occlusive crisis

Other: Evaluation of global longitudinal strain using routinely recorded echocardiography images

Interventions

Evaluation of global longitudinal strain using routinely recorded echocardiography images OTHER

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.

Patients hospitalised in ICU for vaso-occlusive crisis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient with vaso occlusive crisis hospitalised in an intensive care unit.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Bicetre Hospital: lead

Study Sites (1)

Medical Intensive Care Unit

Le Kremlin-Bicêtre, France

RECRUITING

MeSH Terms

Conditions

Anemia, Sickle Cell

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Xavier Monnet, MD, PhD

CONTACT

00331 45 21 35 39; xavier.monnet@aphp.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: April 23, 2021
• First Posted: April 28, 2021
• Study Start: January 1, 2021
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: April 29, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)