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Clinical Trials/NCT04358692
NCT04358692
Completed
Not Applicable

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

University Hospital, Rouen2 sites in 1 country98 target enrollmentJune 30, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Aortic Valve Stenosis
Sponsor
University Hospital, Rouen
Enrollment
98
Locations
2
Primary Endpoint
to compare myocardial stiffness by ShearWave elastography on not beating heart in two groups of patients referred for surgery
Status
Completed
Last Updated
7 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 30, 2020
End Date
June 14, 2024
Last Updated
7 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University Hospital, Rouen
Responsible Party
Sponsor

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
  • Patient undergoing planned myocardial revascularization surgery (coronary bypass);
  • Groups I and II
  • Patient over 18 years of age;
  • Patient having read and understood the information letter and having signed the consent form;
  • 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
  • Mitral valve disease (\> 1/4 confirmed by TTE);
  • Aortic insufficiency (\> 1/4 confirmed by TTE);

Outcomes

Primary Outcomes

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

  • To compare the diastolic myocardial stiffness of the beating heart with the myocardial stiffness of the non-beating heart(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 conventional diastolic indices(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)
  • Correlation between the diastolic myocardial stiffness of the beating heart and the non-beating heart and the prognosis(1 year)
  • To compare epicardial and trans-thoracic diastolic myocardial stiffness(Day 1)

Study Sites (2)

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