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

April 27, 2021 updated by: Xavier Monnet, Bicetre Hospital
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Le Kremlin-Bicêtre, France
        • Recruiting
        • Medical Intensive Care Unit
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Global longitudinal strain
Time Frame: Day 0
Measure of global longitudinal strain using speckle tracking echocardiography
Day 0
Global longitudinal strain
Time Frame: Day 1
Measure of global longitudinal strain using speckle tracking echocardiography
Day 1
Global longitudinal strain
Time Frame: Day 2
Measure of global longitudinal strain using speckle tracking echocardiography
Day 2

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Troponine level
Time Frame: Day 0
Day 0
Troponine level
Time Frame: Day 1
Day 1
Troponine level
Time Frame: Day 2
Day 2
Electrocardiogram QT interval
Time Frame: Day 0
Day 0
Electrocardiogram QT interval
Time Frame: Day 2
Day 2
Electrocardiogram ST elevation
Time Frame: Day 0
Day 0
Electrocardiogram ST elevation
Time Frame: Day 2
Day 2
Electrocardiogram negative T waves
Time Frame: Day 0
Day 0
Electrocardiogram negative T waves
Time Frame: Day 2
Day 2
Thoracic pain
Time Frame: Day 0
Numerical rating scale from 0 to 10 assessed by the patient
Day 0
Thoracic pain
Time Frame: Day 1
Numerical rating scale from 0 to 10 assessed by the patient
Day 1
Thoracic pain
Time Frame: Day 2
Numerical rating scale from 0 to 10 assessed by the patient
Day 2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bicetre Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2021

Primary Completion (Anticipated)

December 1, 2023

Study Completion (Anticipated)

December 1, 2023

Study Registration Dates

First Submitted

April 23, 2021

First Submitted That Met QC Criteria

April 24, 2021

First Posted (Actual)

April 28, 2021

Study Record Updates

Last Update Posted (Actual)

April 29, 2021

Last Update Submitted That Met QC Criteria

April 27, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-A00623-38

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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