Added Value of Speckle Tracking in the Evaluation of Patients With Sickle Cell Disease
Added Value of Speckle Tracking in the Evaluation of Patients With Sickle Cell Disease
Sponsors
Source
Brugmann University Hospital
Oversight Info
Has Dmc
No
Brief Summary
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.
Overall Status
Completed
Start Date
2013-11-01
Completion Date
2016-06-01
Primary Completion Date
2016-06-01
Study Type
Observational
Primary Outcome
Measure |
Time Frame |
|
Cardiac ejection fraction |
once per year, at the annual medical visit planned according to the standart of care for this pathology |
|
Cardiac diastolic function |
once per year, at the annual medical visit planned according to the standart of care for this pathology |
|
Cardiac tissular doppler |
once per year, at the annual medical visit planned according to the standart of care for this pathology |
|
Myocardiac performance index |
once per year, at the annual medical visit planned according to the standart of care for this pathology |
|
Global longitudinal strain |
once per year, at the annual medical visit planned according to the standart of care for this pathology |
|
arterial pulmonary hypertension |
once per year, at the annual medical visit planned according to the standart of care for this pathology |
|
left ventricular hypertrophy |
once per year, at the annual medical visit planned according to the standart of care for this pathology |
Secondary Outcome
Measure |
Time Frame |
|
Biological parameters: hemoglobin levels |
once per year, at the annual medical visit planned according to the standart of care for this pathology |
|
Biological parameters: ferritin levels |
once per year, at the annual medical visit planned according to the standart of care for this pathology |
|
Biological parameters: red cells count |
once per year, at the annual medical visit planned according to the standart of care for this pathology |
|
Biological parameters: hematocrit levels |
once per year, at the annual medical visit planned according to the standart of care for this pathology |
|
Biological parameters: iron levels |
once per year, at the annual medical visit planned according to the standart of care for this pathology |
|
Clinical parameters: severity of the illness |
once per year, at the annual medical visit planned according to the standart of care for this pathology |
|
Clinical parameters: sanguine transfusion numbers |
once per year, at the annual medical visit planned according to the standart of care for this pathology |
Number Of Groups
2
Enrollment
62
Condition
Intervention
Intervention Type
Other
Intervention Name
Description
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.
Arm Group Label
Sickle cell disease patients
Healthy patients
Intervention Type
Other
Intervention Name
Description
Hemoglobin levels, red cells, hematocrit, iron, ferritin
Arm Group Label
Sickle cell disease patients
Healthy patients
Intervention Type
Other
Intervention Name
Description
Blood transfusion number, severity of the sickle cell disease damage, evolution duration of the sickness
Arm Group Label
Sickle cell disease patients
Eligibility
Study Pop
Sickle cell disease patients
Sampling Method
Non-Probability Sample
Criteria
Inclusion Criteria:
- All sickle cell disease patients
Exclusion Criteria:
- Insufficient echogenicity
Gender
All
Minimum Age
18 Years
Maximum Age
N/A
Healthy Volunteers
No
Overall Official
Last Name |
Role |
Affiliation |
|
Marielle MORISSENS, MD |
Principal Investigator |
CHU Brugmann |
Location
Facility |
|
CHU Brugmann Brussels 1020 Belgium |
Location Countries
Country
Belgium
Verification Date
2016-07-01
Lastchanged Date
N/A
Firstreceived Date
N/A
Responsible Party
Responsible Party Type
Principal Investigator
Investigator Affiliation
Brugmann University Hospital
Investigator Full Name
Dr Marielle Morissens
Investigator Title
Deputy Head of Clinic
Keywords
Has Expanded Access
No
Condition Browse
Arm Group
Arm Group Label
Sickle cell disease patients
Description
Sickle cell disease patients
Arm Group Label
Healthy patients
Description
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.
Firstreceived Results Date
N/A
Reference
Citation
Ahmad H, Gayat E, Yodwut C, Abduch MC, Patel AR, Weinert L, Desai A, Tsang W, Garcia JG, Lang RM, Mor-Avi V. Evaluation of myocardial deformation in patients with sickle cell disease and preserved ejection fraction using three-dimensional speckle tracking echocardiography. Echocardiography. 2012 Sep;29(8):962-9. doi: 10.1111/j.1540-8175.2012.01710.x. Epub 2012 May 8.
PMID
22563937
Citation
Knight-Perry JE, de Las Fuentes L, Waggoner AD, Hoffmann RG, Blinder MA, Dávila-Román VG, Field JJ. Abnormalities in cardiac structure and function in adults with sickle cell disease are not associated with pulmonary hypertension. J Am Soc Echocardiogr. 2011 Nov;24(11):1285-90. doi: 10.1016/j.echo.2011.07.009. Epub 2011 Aug 27.
PMID
21873028
Citation
Sachdev V, Machado RF, Shizukuda Y, Rao YN, Sidenko S, Ernst I, St Peter M, Coles WA, Rosing DR, Blackwelder WC, Castro O, Kato GJ, Gladwin MT. Diastolic dysfunction is an independent risk factor for death in patients with sickle cell disease. J Am Coll Cardiol. 2007 Jan 30;49(4):472-9. Epub 2007 Jan 16.
PMID
17258093
Citation
Hankins JS, McCarville MB, Hillenbrand CM, Loeffler RB, Ware RE, Song R, Smeltzer MP, Joshi V. Ventricular diastolic dysfunction in sickle cell anemia is common but not associated with myocardial iron deposition. Pediatr Blood Cancer. 2010 Sep;55(3):495-500. doi: 10.1002/pbc.22587.
PMID
20658621
Citation
Voskaridou E, Christoulas D, Terpos E. Sickle-cell disease and the heart: review of the current literature. Br J Haematol. 2012 Jun;157(6):664-73. doi: 10.1111/j.1365-2141.2012.09143.x. Epub 2012 Apr 25. Review.
PMID
22530942
Citation
Poludasu S, Ramkissoon K, Salciccioli L, Kamran H, Lazar JM. Left ventricular systolic function in sickle cell anemia: a meta-analysis. J Card Fail. 2013 May;19(5):333-41. doi: 10.1016/j.cardfail.2013.03.009. Review.
PMID
23663816
Firstreceived Results Disposition Date
N/A
Study Design Info
Observational Model
Cohort
Time Perspective
Prospective
Study First Submitted
March 10, 2015
Study First Submitted Qc
March 16, 2015
Study First Posted
March 20, 2015
Last Update Submitted
July 25, 2016
Last Update Submitted Qc
July 25, 2016
Last Update Posted
July 26, 2016
ClinicalTrials.gov processed this data on August 29, 2018
Conditions
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conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions
Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied.
Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase
Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions
that study is seeking to answer:
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.