Noninvasive Elastography Evaluation of Myocardial Stiffness in Elderly Patients With Isolated Diastolic Heart Failure: New Diagnostic Tool? (ELASTOCARDIO2)
Primary Purpose
Cardiovascular Diseases in Old Age
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
SuperSonic image
Sponsored by
About this trial
This is an interventional diagnostic trial for Cardiovascular Diseases in Old Age focused on measuring heart failure, myocardial rigidity, new diagnosis, ultrasound imaging
Eligibility Criteria
Global Inclusion Criteria:
- Hospitalization in cardiology services for acute pulmonary edema during heart failure
- Natriuretic peptide type B ≥35 pg/ml
- Echocardiographic structural alteration
Specific Inclusion criteria
- Group "preserved LVEF": Left ventricular Ejection Fraction ≥50%
- Group "moderate alteration of LVEF": Left ventricular Ejection Fraction between 40% and 49%
- Group "Systolic heart failure": Left ventricular Ejection Fraction< 40%
Global Exclusion Criteria:
- Other associated lung pathology
- Other heart disease
- Contraindication to MRI or echocardiography gel
- Pregnancy
- Poor echogenicity,
Sites / Locations
- Emmanuel MESSASRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Stratification
Arm Description
All patient will have the same intervention. They will be stratified regarding their degree of heart failure gravity.
Outcomes
Primary Outcome Measures
Myocardial rigidity assessment
Myocardial rigidity measured using this new non-invasive ultrasound imaging technique.
Secondary Outcome Measures
Norms estimation of myocardial rigidity
Estimation of physiological and pathological norms of myocardial rigidity by elastography
Safety of cardiac elastography
patient monitoring (electrocardiogram scope and constants every10 min) for 30 minutes post-examination associated with a "comfort questionnaire" to be completed by the patient after the examination
Full Information
NCT ID
NCT03895541
First Posted
March 28, 2019
Last Updated
March 22, 2022
Sponsor
French Cardiology Society
1. Study Identification
Unique Protocol Identification Number
NCT03895541
Brief Title
Noninvasive Elastography Evaluation of Myocardial Stiffness in Elderly Patients With Isolated Diastolic Heart Failure: New Diagnostic Tool?
Acronym
ELASTOCARDIO2
Official Title
Noninvasive Elastography Evaluation of Myocardial Stiffness in Elderly Patients With Isolated Diastolic Heart Failure: New Diagnostic Tool?
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 24, 2020 (Actual)
Primary Completion Date
August 31, 2023 (Anticipated)
Study Completion Date
August 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
French Cardiology Society
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The new approach propose in this protocol is based on ultrafast ultrasound and remote palpation of tissue by ultrasonic radiation pressure. Ultrafast ultrasound of biological tissues is based on an innovative ultrasound imaging approach that can image very fast soft tissue events at a rate of several thousands of frames per second and provide quantitative mapping of the elasticity of the tissues. This current project aims is to focus on myocardial rigidity in diastole to better assess the function of the heart failure.
Detailed Description
Diastolic heart failure or heart failure with preserved systolic function is the leading cause of heart failure in elderly subjects (more than 2/3 of heart failure in subjects over 60 years). Its main etiology is high blood pressure. Diagnosis of diastolic heart failure remains controversial in clinical practice. It is based on ultrasound and biological criteria. These are mainly acute edema of the lung for patients with preserved Ejection Fraction and high Brain Natriuretic Peptid. It is now recognized that the "primum movens" of this type of heart failure is the increase in myocardial stiffness secondary to left ventricular hypertrophy. The noninvasive evaluation of this parameter would allow a more accurate and reliable diagnosis since it does not depend on the loading conditions, unlike the heart failure and the trans-mitral Doppler). However, the absence of a non-invasive tool for the direct evaluation of diastolic (so-called passive) rigidity prevents the use of this diagnostic parameter. Investigators propose here to non-invasively evaluate the myocardial stiffness in the elderly patient with diastolic heart failure thanks to a new imaging tool using an innovative ultrasonic technology, the ultrafast-echo associated with its elastographic mode "ShearWave Imaging". Investigators have been working for several years in collaboration with the Langevin Institute on this technology, which has recently been validated on experimental models. Its principle is based on the creation of a shear wave from a standard ultrasound probe and the calculation of the velocity of this wave thanks to the very high temporal resolution of the ultrasound system, this speed being correlated to the myocardial rigidity. The human study was recently made possible by the development of a phased array probe with the ability to work with the elastography mode ("ShearWave Imaging").
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Diseases in Old Age
Keywords
heart failure, myocardial rigidity, new diagnosis, ultrasound imaging
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
stratification
Masking
None (Open Label)
Allocation
N/A
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Stratification
Arm Type
Other
Arm Description
All patient will have the same intervention. They will be stratified regarding their degree of heart failure gravity.
Intervention Type
Diagnostic Test
Intervention Name(s)
SuperSonic image
Intervention Description
3 examen performed assessed to compared evaluation type: Cardiac magnetic resonance imaging, standard ultrasound imaging and ultrafast imaging
Primary Outcome Measure Information:
Title
Myocardial rigidity assessment
Description
Myocardial rigidity measured using this new non-invasive ultrasound imaging technique.
Time Frame
Day 1
Secondary Outcome Measure Information:
Title
Norms estimation of myocardial rigidity
Description
Estimation of physiological and pathological norms of myocardial rigidity by elastography
Time Frame
Day 1
Title
Safety of cardiac elastography
Description
patient monitoring (electrocardiogram scope and constants every10 min) for 30 minutes post-examination associated with a "comfort questionnaire" to be completed by the patient after the examination
Time Frame
Day 1
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Global Inclusion Criteria:
Hospitalization in cardiology services for acute pulmonary edema during heart failure
Natriuretic peptide type B ≥35 pg/ml
Echocardiographic structural alteration
Specific Inclusion criteria
Group "preserved LVEF": Left ventricular Ejection Fraction ≥50%
Group "moderate alteration of LVEF": Left ventricular Ejection Fraction between 40% and 49%
Group "Systolic heart failure": Left ventricular Ejection Fraction< 40%
Global Exclusion Criteria:
Other associated lung pathology
Other heart disease
Contraindication to MRI or echocardiography gel
Pregnancy
Poor echogenicity,
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Emmanuel MESSAS, MD
Phone
33 6 65 03 85 02
Email
emmanuel.messas@aphp.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Tessa BERGOT
Phone
33 144907033
Email
tessa.bergot@sfcardio.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emmanuel MESSAS, MD
Organizational Affiliation
Hopital Européen Georges Pompidou
Official's Role
Principal Investigator
Facility Information:
Facility Name
Emmanuel MESSAS
City
Paris
ZIP/Postal Code
75015
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emmanuel MESSAS, Pr
Phone
33 6 65 03 85 02
Email
emmanuel.messas@aphp.fr
First Name & Middle Initial & Last Name & Degree
Samuel ZARKA, Dr
Phone
33 1 56 09 37 55
Email
samuel.zarka@aphp.fr
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Noninvasive Elastography Evaluation of Myocardial Stiffness in Elderly Patients With Isolated Diastolic Heart Failure: New Diagnostic Tool?
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