Measurement of Myocardial Stiffness Using Elastometry in Patients With Aortic Stenosis (ELASTOP-AS)
Primary Purpose
Aortic Valve Stenosis
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Aixplorer Mach30
Sponsored by
About this trial
This is an interventional diagnostic trial for Aortic Valve Stenosis focused on measuring Elastography, Myocardial stiffness, Surgical Aortic Valve Replacement
Eligibility Criteria
Inclusion Criteria:
Group I (aortic stenosis):
1. Patient undergoing planned surgical aortic valve replacement (SAVR) for aortic stenosis (aortic valve area <1cm² or an aortic valve area index <0.6 cm² / m²);
- Group II: coronary bypass 2. Patient undergoing planned myocardial revascularization surgery (coronary bypass);
- Groups I and II 3. Patient over 18 years of age; 4. Patient having read and understood the information letter and having signed the consent form; 5. Patient affiliated or benefiting from a health insurance scheme
Exclusion Criteria:
Group II: coronary bypass
- Ratio in TM mode of the wall thickness over the radius of the left ventricle (h / r [0.45]) confirmed by the TTE;
- Scar of myocardial infarction defined by an ECG anomaly and / or hypo-akinesia on TTE, and / or a late enhancement in MRI;
- Acute coronary syndrome less than 3 months old;
- Significant aortic stenosis (Vmax> 1.5 m / s);
- Anomaly of segmental kinetics;
- Presence of left ventricular hypertrophy
- Groups I and II 7. Mitral valve disease (> 1/4 confirmed by TTE); 8. Aortic insufficiency (> 1/4 confirmed by TTE); 9. Left ventricle ejection fraction (LVEF) <50% confirmed by TTE; 10. Hospitalization for heart failure less than 3 months old; 11. Urgent surgery; 12. Infiltrative heart disease; 13. Hostile pericardium defined by a history of mediastinal radiotherapy, tamponade or complicated pericarditis; 14. Decompensated or severe arterial hypertension. 15. Functional inability to walk preventing the performance of the walk test; 16. Proven pregnant woman (positive urine pregnancy test) or breastfeeding or absence of effective contraception (as defined by the WHO) or postmenopausal woman without confirmation diagnosis obtained (amenorrhea not medically induced for at least 12 months before the initiation visit) ; 17. Person deprived of their liberty by an administrative or judicial decision or person placed under the protection of justice / guardianship or curatorship 18. History of illness or psychological or sensory abnormality likely to prevent the subject from fully understanding the conditions required for participating in the protocol or preventing him from giving his informed consent
Sites / Locations
- CHU CaenRecruiting
- CHU de RouenRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Surgical Aortic Valve Replacement
Reference
Arm Description
Patients with aortic stenosis
Coronary bypass patients without hypertrophic left ventricular remodeling or sequelae of myocardial infarction
Outcomes
Primary Outcome Measures
to compare myocardial stiffness by ShearWave elastography on not beating heart in two groups of patients referred for surgery
The main outcome measure is evaluated by ShearWave elastography with the measurement of Young modulus on non-beating heart
Secondary Outcome Measures
To compare the diastolic myocardial stiffness of the beating heart with the myocardial stiffness of the non-beating heart
This outcome measure is evaluated by ShearWave elastography with the measurement of Young modulus on non-beating heart
To compare epicardial and trans-thoracic diastolic myocardial stiffness
This outcome measure is evaluated by elastography using the measurement of Young modulus in epicardial (using the linear probe) and transthoracic (using the scanning probe).
Correlation between the diastolic myocardial stiffness of the beating heart and the non-beating heart with conventional diastolic indices
This outcome measure is evaluated:
by ShearWave elastography with the measurement of Young modulus on non-beating heart
by conventional ultrasound criteria (peak e', peak E, volume of the left atrium calculated by simpson biplanes, maximum velocity of tricuspid insufficiency).
Correlation between the diastolic myocardial stiffness of the beating heart and the non-beating heart with heart failure parameters
This outcome measure is evaluated:
by ShearWave elastography with the measurement of Young modulus on non-beating heart
by heart failure parameters defined by NYHA class, the walking test and the BNP assay
Correlation between the diastolic myocardial stiffness of the beating heart and the non-beating heart with left ventricular mass indexed to the body surface
This outcome measure is evaluated:
by ShearWave elastography with the measurement of Young modulus on non-beating heart
by LV mass indexed to the body surface calculated by the cardiac mass measuring by ultrasound indexed to the body surface
Correlation between the diastolic myocardial stiffness of the beating heart and the non-beating heart and the prognosis
This outcome measure is evaluated:
by ShearWave elastography with the measurement of Young modulus on non-beating heart
by a combined index combining all rehospitalization for heart failure, increase in heart failure treatment and cardiac death
Full Information
NCT ID
NCT04358692
First Posted
April 9, 2020
Last Updated
May 12, 2023
Sponsor
University Hospital, Rouen
Collaborators
University Hospital, Caen
1. Study Identification
Unique Protocol Identification Number
NCT04358692
Brief Title
Measurement of Myocardial Stiffness Using Elastometry in Patients With Aortic Stenosis
Acronym
ELASTOP-AS
Official Title
Epicardial Measurement of Myocardial Stiffness on Beating Heart and Non-beating Heart During a Programmed Surgical Aortic Valve Replacement for Aortic Stenosis
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 30, 2020 (Actual)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Rouen
Collaborators
University Hospital, Caen
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
Elastography is a new non-invasive medical technique for measuring the stiffness at a distance from a tissue. Recent advances in the development of elastography sequences for cardiac exploration suggest a more clinical approach to cardiac elastography. This study propose to compare myocardial stiffness of a group of coronary bypass patients without hypertrophic left ventricular remodeling or sequelae of myocardial infarction versus a group of patients who should benefit from a surgical aortic valve replacement for aortic stenosis.
The hypothesis is that the physiological adaptation to pressure overload constituted by aortic stenosis is responsible for a significant increase in myocardial stiffness compared to a reference group.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Valve Stenosis
Keywords
Elastography, Myocardial stiffness, Surgical Aortic Valve Replacement
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
92 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Surgical Aortic Valve Replacement
Arm Type
Experimental
Arm Description
Patients with aortic stenosis
Arm Title
Reference
Arm Type
Other
Arm Description
Coronary bypass patients without hypertrophic left ventricular remodeling or sequelae of myocardial infarction
Intervention Type
Device
Intervention Name(s)
Aixplorer Mach30
Intervention Description
To measure myocardial stiffness by ShearWave elastography on not beating heart
Primary Outcome Measure Information:
Title
to compare myocardial stiffness by ShearWave elastography on not beating heart in two groups of patients referred for surgery
Description
The main outcome measure is evaluated by ShearWave elastography with the measurement of Young modulus on non-beating heart
Time Frame
Day 1
Secondary Outcome Measure Information:
Title
To compare the diastolic myocardial stiffness of the beating heart with the myocardial stiffness of the non-beating heart
Description
This outcome measure is evaluated by ShearWave elastography with the measurement of Young modulus on non-beating heart
Time Frame
Day 1
Title
To compare epicardial and trans-thoracic diastolic myocardial stiffness
Description
This outcome measure is evaluated by elastography using the measurement of Young modulus in epicardial (using the linear probe) and transthoracic (using the scanning probe).
Time Frame
Day 1
Title
Correlation between the diastolic myocardial stiffness of the beating heart and the non-beating heart with conventional diastolic indices
Description
This outcome measure is evaluated:
by ShearWave elastography with the measurement of Young modulus on non-beating heart
by conventional ultrasound criteria (peak e', peak E, volume of the left atrium calculated by simpson biplanes, maximum velocity of tricuspid insufficiency).
Time Frame
Day 1
Title
Correlation between the diastolic myocardial stiffness of the beating heart and the non-beating heart with heart failure parameters
Description
This outcome measure is evaluated:
by ShearWave elastography with the measurement of Young modulus on non-beating heart
by heart failure parameters defined by NYHA class, the walking test and the BNP assay
Time Frame
Day 1
Title
Correlation between the diastolic myocardial stiffness of the beating heart and the non-beating heart with left ventricular mass indexed to the body surface
Description
This outcome measure is evaluated:
by ShearWave elastography with the measurement of Young modulus on non-beating heart
by LV mass indexed to the body surface calculated by the cardiac mass measuring by ultrasound indexed to the body surface
Time Frame
Day 1
Title
Correlation between the diastolic myocardial stiffness of the beating heart and the non-beating heart and the prognosis
Description
This outcome measure is evaluated:
by ShearWave elastography with the measurement of Young modulus on non-beating heart
by a combined index combining all rehospitalization for heart failure, increase in heart failure treatment and cardiac death
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Group I (aortic stenosis):
1. Patient undergoing planned surgical aortic valve replacement (SAVR) for aortic stenosis (aortic valve area <1cm² or an aortic valve area index <0.6 cm² / m²);
Group II: coronary bypass 2. Patient undergoing planned myocardial revascularization surgery (coronary bypass);
Groups I and II 3. Patient over 18 years of age; 4. Patient having read and understood the information letter and having signed the consent form; 5. Patient affiliated or benefiting from a health insurance scheme
Exclusion Criteria:
Group II: coronary bypass
Ratio in TM mode of the wall thickness over the radius of the left ventricle (h / r [0.45]) confirmed by the TTE;
Scar of myocardial infarction defined by an ECG anomaly and / or hypo-akinesia on TTE, and / or a late enhancement in MRI;
Acute coronary syndrome less than 3 months old;
Significant aortic stenosis (Vmax> 1.5 m / s);
Anomaly of segmental kinetics;
Presence of left ventricular hypertrophy
Groups I and II 7. Mitral valve disease (> 1/4 confirmed by TTE); 8. Aortic insufficiency (> 1/4 confirmed by TTE); 9. Left ventricle ejection fraction (LVEF) <50% confirmed by TTE; 10. Hospitalization for heart failure less than 3 months old; 11. Urgent surgery; 12. Infiltrative heart disease; 13. Hostile pericardium defined by a history of mediastinal radiotherapy, tamponade or complicated pericarditis; 14. Decompensated or severe arterial hypertension. 15. Functional inability to walk preventing the performance of the walk test; 16. Proven pregnant woman (positive urine pregnancy test) or breastfeeding or absence of effective contraception (as defined by the WHO) or postmenopausal woman without confirmation diagnosis obtained (amenorrhea not medically induced for at least 12 months before the initiation visit) ; 17. Person deprived of their liberty by an administrative or judicial decision or person placed under the protection of justice / guardianship or curatorship 18. History of illness or psychological or sensory abnormality likely to prevent the subject from fully understanding the conditions required for participating in the protocol or preventing him from giving his informed consent
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hélène Eltchaninoff, MD
Phone
0232888232
Ext
+33
Email
helene.eltchaninoff@chu-rouen.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Delphine Béziau-Gasnier, PhD
Phone
0232886766
Ext
+33
Email
delphine.beziau-gasnier@chu-rouen.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric Saloux, MD
Organizational Affiliation
University Hospital, Caen
Official's Role
Study Director
Facility Information:
Facility Name
CHU Caen
City
Caen
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eric Saloux, MD
Facility Name
CHU de Rouen
City
Rouen
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hélène Eltchaninoff, MD
12. IPD Sharing Statement
Plan to Share IPD
No
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Measurement of Myocardial Stiffness Using Elastometry in Patients With Aortic Stenosis
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