Measurement of Myocardial Stiffness Using Elastometry in Patients With Aortic Stenosis

NCT04358692 | Completed

• 1 other identifier: 2019/0254/HP
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 2

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.

Conditions

Aortic Valve Stenosis

Keywords

Elastography; Myocardial stiffness; Surgical Aortic Valve Replacement

Outcome Measures

Primary Outcomes (1)

• 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

  Day 1

Secondary Outcomes (6)

• To compare the diastolic myocardial stiffness of the beating heart with the myocardial stiffness of the non-beating heart

  Day 1

• To compare epicardial and trans-thoracic diastolic myocardial stiffness

  Day 1

• Correlation between the diastolic myocardial stiffness of the beating heart and the non-beating heart with conventional diastolic indices

  Day 1

• Correlation between the diastolic myocardial stiffness of the beating heart and the non-beating heart with heart failure parameters

  Day 1

• Correlation between the diastolic myocardial stiffness of the beating heart and the non-beating heart with left ventricular mass indexed to the body surface

  Day 1

Study Arms (2)

Surgical Aortic Valve Replacement

EXPERIMENTAL

Patients with aortic stenosis

Device: Aixplorer Mach30

Reference

OTHER

Coronary bypass patients without hypertrophic left ventricular remodeling or sequelae of myocardial infarction

Device: Aixplorer Mach30

Interventions

Aixplorer Mach30 DEVICE

To measure myocardial stiffness by ShearWave elastography on not beating heart

Reference; Surgical Aortic Valve Replacement

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Group I (aortic stenosis):
• \. 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Rouen: lead
• University Hospital, Caen: collaborator

Study Sites (2)

CHU Caen

Caen, France

Location

CHU de Rouen

Rouen, France

Location

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Study Officials

• Eric Saloux, MD

  University Hospital, Caen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2020
• First Posted: April 24, 2020
• Study Start: June 30, 2020
• Primary Completion: June 14, 2024
• Study Completion: June 14, 2024
• Last Updated: September 10, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)