Added Value of Speckle Tracking in the Evaluation of Patients With Sickle Cell Disease

July 25, 2016 updated by: Dr Marielle Morissens, Brugmann University Hospital

Sickle Cell Disease is a serious disease that is life-threatening for patients being homozygous for the SS form or heterozygous for the SC or βthal forms. The CHU Brugmann hospital currently regularly treats about 70 homozygous adult patients and this number is in constant augmentation.

Sickle cell disease patients may develop a cardiomyopathy due to chronic anemia, the haemosiderosis risk or, less frequently, to coronary vaso-occlusive damages.

The hypervolemia in patients with sickle cell disease causes an overestimation of the ejected left ventricular fraction measured by echocardiography, this parameter being very dependent of the blood volume.It has already been shown that the left ventricular ejection fraction was normal in most patients with sickle cell disease, but that its evaluation by parameters independent from the blood volume showed the existence of a dysfunction.

Myocardial strain, as measured by speckle tracking, is a echographic evaluation method of the cardiac function, independent of the blood volume. This technique hasn't been used much in sickle cell disease patients. A study using 3D speckle tracking on a limited number of sickle cell disease patients failed to show a strain anomaly. Moreover, the study highlighted a higher global longitudinal strain in this patient population. The investigators find these data hard to explain and in contradiction with previous studies using other cardiac function evaluation techniques, independent from the blood volume.

The primary goal of this study is thus

  • to study the longitudinal strain by 2D echography
  • to determine if anomalies of the longitudinal strain exist in sickle cell disease patients with a normal ejected left ventricular fraction, compared to a control group of healthy patients.

The secondary goal of this study is to correlate, inside the sickle cell disease group, the possible strain anomalies with biological gravity parameters of the disease.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

62

Contacts and Locations

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

Study Locations

  • Belgium
      • Brussels, Belgium, 1020
        • CHU Brugmann

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

Sickle cell disease patients

Description

Inclusion Criteria:

  • All sickle cell disease patients

Exclusion Criteria:

  • Insufficient echogenicity

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Sickle cell disease patients
Other: Cardiac echography
Ejection fraction measured by Teicholz and planimetry, diastolic function, tissular doppler, myocardiac performance index, global longitudinal strain measured by speckle tracking, arterial pulmonary hypertension, left ventricular hypertrophy.
Other: Biological parameters
Hemoglobin levels, red cells, hematocrit, iron, ferritin
Other: Clinical parameters
Blood transfusion number, severity of the sickle cell disease damage, evolution duration of the sickness
Healthy patients
This is the control group for the sickle cell disease patients: each sickle cell disease patient will be matched with a healthy patient of the same sex and of similar age.
Other: Cardiac echography
Ejection fraction measured by Teicholz and planimetry, diastolic function, tissular doppler, myocardiac performance index, global longitudinal strain measured by speckle tracking, arterial pulmonary hypertension, left ventricular hypertrophy.
Other: Biological parameters
Hemoglobin levels, red cells, hematocrit, iron, ferritin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiac ejection fraction
Time Frame: once per year, at the annual medical visit planned according to the standart of care for this pathology
Ejection fraction measured by Teicholz and planimety.
once per year, at the annual medical visit planned according to the standart of care for this pathology
Cardiac diastolic function
Time Frame: once per year, at the annual medical visit planned according to the standart of care for this pathology
once per year, at the annual medical visit planned according to the standart of care for this pathology
Cardiac tissular doppler
Time Frame: once per year, at the annual medical visit planned according to the standart of care for this pathology
once per year, at the annual medical visit planned according to the standart of care for this pathology
Myocardiac performance index
Time Frame: once per year, at the annual medical visit planned according to the standart of care for this pathology
once per year, at the annual medical visit planned according to the standart of care for this pathology
Global longitudinal strain
Time Frame: once per year, at the annual medical visit planned according to the standart of care for this pathology
Global longitudinal strain measured by speckle tracking.
once per year, at the annual medical visit planned according to the standart of care for this pathology
arterial pulmonary hypertension
Time Frame: once per year, at the annual medical visit planned according to the standart of care for this pathology
once per year, at the annual medical visit planned according to the standart of care for this pathology
left ventricular hypertrophy
Time Frame: once per year, at the annual medical visit planned according to the standart of care for this pathology
once per year, at the annual medical visit planned according to the standart of care for this pathology

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Biological parameters: hemoglobin levels
Time Frame: once per year, at the annual medical visit planned according to the standart of care for this pathology
once per year, at the annual medical visit planned according to the standart of care for this pathology
Biological parameters: ferritin levels
Time Frame: once per year, at the annual medical visit planned according to the standart of care for this pathology
once per year, at the annual medical visit planned according to the standart of care for this pathology
Biological parameters: red cells count
Time Frame: once per year, at the annual medical visit planned according to the standart of care for this pathology
once per year, at the annual medical visit planned according to the standart of care for this pathology
Biological parameters: hematocrit levels
Time Frame: once per year, at the annual medical visit planned according to the standart of care for this pathology
once per year, at the annual medical visit planned according to the standart of care for this pathology
Biological parameters: iron levels
Time Frame: once per year, at the annual medical visit planned according to the standart of care for this pathology
once per year, at the annual medical visit planned according to the standart of care for this pathology
Clinical parameters: severity of the illness
Time Frame: once per year, at the annual medical visit planned according to the standart of care for this pathology
Sickle cell disease organ damages.
once per year, at the annual medical visit planned according to the standart of care for this pathology
Clinical parameters: sanguine transfusion numbers
Time Frame: once per year, at the annual medical visit planned according to the standart of care for this pathology
once per year, at the annual medical visit planned according to the standart of care for this pathology

Collaborators and Investigators

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

Sponsor

Brugmann University Hospital

Investigators

  • Principal Investigator: Marielle MORISSENS, MD, CHU Brugmann

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

November 1, 2013

Primary Completion (Actual)

June 1, 2016

Study Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

March 10, 2015

First Submitted That Met QC Criteria

March 16, 2015

First Posted (Estimate)

March 20, 2015

Study Record Updates

Last Update Posted (Estimate)

July 26, 2016

Last Update Submitted That Met QC Criteria

July 25, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHUB-Echo-Cardio

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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