Ignite Creation Date:
2024-05-06 @ 7:27 AM
Last Modification Date:
2024-10-26 @ 11:48 AM
Study NCT ID:
NCT02537041
Status:
COMPLETED
Last Update Posted:
2017-11-06
First Post:
2015-08-24
Brief Title:
Non-invasive Evaluation of Myocardial Stiffness by Elastography
Sponsor:
French Cardiology Society
Organization:
French Cardiology Society
Study Overview
Official Title:
Non-invasive Evaluation of Myocardial Stiffness by Elastography in the Elderly Suffering From Isolated Diastolic Heart Failure New Diagnostic Tool
Status:
COMPLETED
Status Verified Date:
2017-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Elasto-Cardio
Brief Summary:
SITUATION ON RESEARCH Diastolic heart failure HF or heart failure with preserved systolic function SF is the primary cause of heart failure in the elderly over 23 of heart failure in patients over 60 years Its main cause is hypertension The diagnosis of diastolic heart failure is still controversial in clinical practice It is based on ultrasound and biological criteria or MRI Basically it is concerned patients making acute pulmonary edema with preserved SF and high BNP It is now recognized that the primum movens of this type of HF is increased myocardial stiffness secondary to LVH Noninvasive assessment of this parameter would allow a more accurate and reliable diagnosis because not dependent on load conditions unlike the ejection fraction EF and trans-mitral Doppler However the absence of non-invasive tool for the direct evaluation of the diastolic stiffness so-called passive prevents to date to use this diagnostic parameter
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
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:
DESCRIPTION PROJECT SUMMARY
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 elderlys 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
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 elderlys 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None