Noninvasive Elastography Evaluation of Myocardial Stiffness in Elderly Patients With Isolated Diastolic Heart Failure: New Diagnostic Tool?
ELASTOCARDIO2
1 other identifier
interventional
90
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2020
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 28, 2019
CompletedFirst Posted
Study publicly available on registry
March 29, 2019
CompletedStudy Start
First participant enrolled
January 24, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2025
CompletedMarch 11, 2025
March 1, 2025
5.9 years
March 28, 2019
March 10, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Myocardial rigidity assessment
Myocardial rigidity measured using this new non-invasive ultrasound imaging technique.
Day 1
Secondary Outcomes (2)
Norms estimation of myocardial rigidity
Day 1
Safety of cardiac elastography
Day 1
Study Arms (1)
Stratification
OTHERAll patient will have the same intervention. They will be stratified regarding their degree of heart failure gravity.
Interventions
3 examen performed assessed to compared evaluation type: Cardiac magnetic resonance imaging, standard ultrasound imaging and ultrafast imaging
Eligibility Criteria
You may qualify if:
- Hospitalization in cardiology services for acute pulmonary edema during heart failure
- Natriuretic peptide type B ≥35 pg/ml
- Echocardiographic structural alteration
- 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%
You may not qualify if:
- Other associated lung pathology
- Other heart disease
- Contraindication to MRI or echocardiography gel
- Pregnancy
- Poor echogenicity,
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Emmanuel MESSAS
Paris, 75015, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Emmanuel MESSAS, MD
Hopital Européen Georges Pompidou
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 28, 2019
First Posted
March 29, 2019
Study Start
January 24, 2020
Primary Completion
December 31, 2025
Study Completion
December 31, 2025
Last Updated
March 11, 2025
Record last verified: 2025-03
Data Sharing
- IPD Sharing
- Will not share