Measurement of Myocardial Stiffness Using Elastometry in Patients With Aortic Stenosis

NCT ID: NCT04358692

Last Updated: 2025-09-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 98 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-30
• Study Completion Date: 2024-06-14

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Surgical Aortic Valve Replacement

Patients with aortic stenosis

Group Type: EXPERIMENTAL

Aixplorer Mach30

Intervention Type: DEVICE

To measure myocardial stiffness by ShearWave elastography on not beating heart

Reference

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

Group Type: OTHER

Aixplorer Mach30

Intervention Type: DEVICE

To measure myocardial stiffness by ShearWave elastography on not beating heart

Interventions

Aixplorer Mach30

To measure myocardial stiffness by ShearWave elastography on not beating heart

Intervention Type: DEVICE

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

1. Ratio in TM mode of the wall thickness over the radius of the left ventricle (h / r [0.45]) confirmed by the TTE;

2. Scar of myocardial infarction defined by an ECG anomaly and / or hypo-akinesia on TTE, and / or a late enhancement in MRI;

3. Acute coronary syndrome less than 3 months old;

4. Significant aortic stenosis (Vmax> 1.5 m / s);

5. Anomaly of segmental kinetics;

6. 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Caen

OTHER

Sponsor Role: collaborator

University Hospital, Rouen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Eric Saloux, MD

Role: STUDY_DIRECTOR

University Hospital, Caen

Locations

CHU Caen

Caen, , France

CHU de Rouen

Rouen, , France

Countries

France

Other Identifiers

2019/0254/HP

Identifier Type: -

Identifier Source: org_study_id