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
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Anemia, Sickle Cell
• Sickle Cell Disease

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