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Completed

NCT Number: NCT04358692

Measurement of Myocardial Stiffness Using Elastometry in Patients With Aortic Stenosis

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Caen, Caen, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

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

Treatment and study plan

Aixplorer Mach30

Device

To measure myocardial stiffness by ShearWave elastography on not beating heart

Primary outcomes

  1. to compare myocardial stiffness by ShearWave elastography on not beating heart in two groups of patients referred for surgery

    Time frame: Day 1

    The main outcome measure is evaluated by ShearWave elastography with the measurement of Young modulus on non-beating heart

Secondary outcomes

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

    Time frame: Day 1

    This outcome measure is evaluated by ShearWave elastography with the measurement of Young modulus on non-beating heart

  2. To compare epicardial and trans-thoracic diastolic myocardial stiffness

    Time frame: Day 1

    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).

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

    Time frame: Day 1

    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).
  4. Correlation between the diastolic myocardial stiffness of the beating heart and the non-beating heart with heart failure parameters

    Time frame: Day 1

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

    Time frame: Day 1

    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
  6. Correlation between the diastolic myocardial stiffness of the beating heart and the non-beating heart and the prognosis

    Time frame: 1 year

    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

Sponsors and collaborators

Lead sponsor

University Hospital, Rouen

Other

Collaborators

  • University Hospital, Caen

Registry information

Official study title

Epicardial Measurement of Myocardial Stiffness on Beating Heart and Non-beating Heart During a Programmed Surgical Aortic Valve Replacement for Aortic Stenosis

Acronym: ELASTOP-AS

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Apr 24, 2020
Registry last updated
Sep 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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