Measurement of Cardiac Elastography: an Intraoperative Cardiac Surgery Study. Cardiac Elastography in Vivo
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Young's Modulus measurement according to the equation E = Young 3ρCs ²
研究概览
简要总结
Since 20 years, the techniques of direct measurement of cardiac stiffness in the diagnosis of myocardial diseases do not exist.
We propose a human study evaluating the direct measurement of cardiac ultrasound stiffness by elastography.
This study will include 30 patients with cardiac disease whose rigidity varies with underlying disease.
The purpose of this study is to evaluate the stiffness during open heart surgery.
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written consent
- •Patients older than 18 years
- •Every patient scheduled for cardiac surgery
- •Cardiac catheterization within 6 months before surgery,
- •Women of childbearing age in effective contraception (a urine pregnancy test will be performed)
- •Patient affiliated or covered by a plan of health insurance.
- •Francophone
排除标准
- •Pregnant or lactating woman,
- •Functional walking disability,
- •Patient placed under judicial protection: guardianship,
- •Patient participating in another trial and / or participated in another trial within two months,
- •Patient under guardianship or trusteeship,
- •Women who are not effective contraception,
- •Patient with no liberty by administrative or judicial decision
结局指标
主要结局
Young's Modulus measurement according to the equation E = Young 3ρCs ²
时间窗: During herat surgery (Day 0)
Ultrasound acquisition will be completed in epicardial vue using a linear probe SuperLinear 15-4 ™ connected to an ultrasound (AixplorerTM ® from Supersonic Imagine). The acquisitions will be completed in mode B + Elastrography Shear Wave ™ (SWE). A sterile gel is deposited in the bottom of the pouch of sterile protection of the probe. Many measurements will be done on accessible left and right ventricle areas. Measurement of Young's modulus: automated by the onboard model according to the equation E = Young 3ρCs ², where E is the Young's elastic modulus software, ρ is the tissue density and Cs the velocity of shear wave
次要结局
- diastolic function parameters(Day 0)