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NCT04864041 Clinical Trial

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

Sickle Cell Disease Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04864041
Other study ID # 2021-A00623-38
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 1, 2021
Est. completion date December 1, 2023

Study information
Verified date April 2021
Source Bicetre Hospital
Contact Xavier Monnet, MD, PhD
Phone 00331 45 21 35 39
Email xavier.monnet@aphp.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 30
Est. completion date December 1, 2023
Est. primary completion date December 1, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
France Medical Intensive Care Unit Le Kremlin-Bicêtre

Sponsors (1)
Lead Sponsor Collaborator
Bicetre Hospital

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Global longitudinal strain Measure of global longitudinal strain using speckle tracking echocardiography Day 0
Primary Global longitudinal strain Measure of global longitudinal strain using speckle tracking echocardiography Day 1
Primary Global longitudinal strain Measure of global longitudinal strain using speckle tracking echocardiography Day 2
Secondary Troponine level Day 0
Secondary Troponine level Day 1
Secondary Troponine level Day 2
Secondary Electrocardiogram QT interval Day 0
Secondary Electrocardiogram QT interval Day 2
Secondary Electrocardiogram ST elevation Day 0
Secondary Electrocardiogram ST elevation Day 2
Secondary Electrocardiogram negative T waves Day 0
Secondary Electrocardiogram negative T waves Day 2
Secondary Thoracic pain Numerical rating scale from 0 to 10 assessed by the patient Day 0
Secondary Thoracic pain Numerical rating scale from 0 to 10 assessed by the patient Day 1
Secondary Thoracic pain Numerical rating scale from 0 to 10 assessed by the patient Day 2
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