Non-invasive Evaluation of Myocardial Stiffness by Elastography
NCT ID: NCT02537041
Last Updated: 2017-11-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
100 participants
INTERVENTIONAL
2015-09-30
2017-07-31
Brief Summary
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The investigators propose here to evaluate noninvasively myocardial stiffness in elderly patients with diastolic heart failure using a new imaging tool that uses an innovative ultrasonic technology, the ultrafast echo associated with its elastography function "ShearWave Imaging" (SWI). The investigators work for several years in collaboration with the Langevin Institute on this technology which was recently validated in experimental models. Its principle is based on the creation of a shear wave from a standard ultrasound and calculating the velocity of this wave with the high time resolution of the ultrasound probe, this being correlated with the speed myocardial stiffness.
The human study was recently made possible by the development of a phased array probe having the opportunity to work with elastography mode (SWI).
PURPOSE OF RESEARCH The goal will be to demonstrate the interest of the non-invasive evaluation by ultrafast echo (SWI) of myocardial stiffness in the diagnosis of diastolic heart failure in the elderly.
Detailed Description
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Three groups of patients in sinus rhythm will be studied (n total = 100 patients):
* Group 1 "healthy volunteers" (n = 40): two age classes determined (\[20-40ans, n = 20\] and \[60-80 years, n = 20\]), to obtain normal values diastolic myocardial stiffness references. The objective will be to confirm the increase with age in myocardial stiffness assessed by elastography in healthy subjects.
* Group 2 "diastolic HF" (n = 40): older patients with isolated diastolic HF (EF\> 45%, 60-80 years, n = 20) and infiltrative cardiomyopathy restrictive-type amyloidosis (n = 20) . The objective will be to study the results of elastography on two separate clinical types of IC diastolic well identified.
* Group 3 "systolic HF" (n = 20): elderly patients with heart failure with impaired ejection (\<45%) fraction, but no segmental dysfunction.
The evaluation of myocardial stiffness by elastography in all these patients will be compared to conventionally ultrasound and biological parameters currently used for diagnosis of elderly's diastolic HF. Our hypothesis is that myocardial stiffness assessed by SWI is a powerful parameter for predicting diastolic heart failure. To this end, a univariate and multivariate statistical analysis will be carried out from all of these data.
EXPECTED RESULTS AND OUTLOOK The current ultrasound diagnostic parameters of diastolic heart failure (ESC 2012) using Doppler (trans-mitral tissue) anatomical, or functional (strain, strain rate, speckle tracking) criteria that are dependent on load conditions and are not specific to diastolic HF. This study should demonstrate the continuity of our preclinical studies, the non-invasive assessment of myocardial stiffness by elastography is a powerful test for the detection and diagnosis of diastolic heart failure. Secondly the prognosis character of recovery rates will be studied over a large population of people with HF and FE preserved (diastolic HF) with longitudinal follow-up.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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healthy volunteers
to obtain normal values diastolic myocardial stiffness references. The objective will be to confirm the increase with age in myocardial stiffness assessed by elastography in healthy subjects.
elastography function ShearWave Imaging
non-invasive assessment of myocardial stiffness by elastography
MRI
diastolic Heart Failure
older patients with isolated diastolic HF (EF\> 45%, 60-80 years, n = 20) and infiltrative cardiomyopathy restrictive-type amyloidosis (n = 20) . The objective will be to study the results of elastography on two separate clinical types of IC diastolic well identified.
elastography function ShearWave Imaging
non-invasive assessment of myocardial stiffness by elastography
MRI
systolic Heart Failure
elderly patients with heart failure with impaired ejection (\<45%) fraction, but no segmental dysfunction.
The evaluation of myocardial stiffness by elastography in all these patients will be compared to conventionally ultrasound and biological parameters currently used for diagnosis of elderly's diastolic HF
elastography function ShearWave Imaging
non-invasive assessment of myocardial stiffness by elastography
MRI
Interventions
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elastography function ShearWave Imaging
non-invasive assessment of myocardial stiffness by elastography
MRI
Eligibility Criteria
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Inclusion Criteria
* Group 2 "diastolic HF" (n = 40): older patients with isolated diastolic HF (EF\> 45%, 60-80 years, n = 20) and infiltrative cardiomyopathy restrictive-type amyloidosis (n = 20)
* Group 3 "systolic HF" (n = 20): elderly patients with heart failure with impaired ejection (\<45%) fraction, but no segmental dysfunction
Exclusion Criteria
* atrial fibrillation
* patient with defibrillator, pacemaker
* contraindication to MRI
* no consent form
* echography gel allergy
* participation to another study
20 Years
80 Years
ALL
Yes
Sponsors
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Institut National de la Santé Et de la Recherche Médicale, France
OTHER_GOV
French Cardiology Society
OTHER
Responsible Party
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Principal Investigators
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Olivier VILLEMAIN, MD
Role: STUDY_CHAIR
LAngevin Institute
Locations
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Hopital Europeen Georges Pompidou
Paris, , France
Countries
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References
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Villemain O, Correia M, Mousseaux E, Baranger J, Zarka S, Podetti I, Soulat G, Damy T, Hagege A, Tanter M, Pernot M, Messas E. Myocardial Stiffness Evaluation Using Noninvasive Shear Wave Imaging in Healthy and Hypertrophic Cardiomyopathic Adults. JACC Cardiovasc Imaging. 2019 Jul;12(7 Pt 1):1135-1145. doi: 10.1016/j.jcmg.2018.02.002. Epub 2018 Mar 14.
Other Identifiers
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2014-02
Identifier Type: -
Identifier Source: org_study_id