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临床试验/NCT06286358
NCT06286358招募中不适用

Impact of Aortic Valve Disease and Thoracic Aortic Aneurysm on Kinocardiographic Signals

Université Libre de Bruxelles2 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2024年3月7日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
180
试验地点
2
主要终点
Understand and assess the complex mechanisms underlying the modifications of KCG signals in patients with AVD and/or TAA

研究概览

简要总结

Kinocardiography (KCG) is a portable measurement technique developed to estimate cardiac mechanical performance by studying the vibrations produced by myocardial contraction during each heartbeat and transmitted to the body surface.

The goal of this observational study is to learn about kinocardiography in patients with aortic valve disease (AVD) or thoracic aortic aneurysm (TAA). The investigators believe that this technology will enable to diagnose aortic valve disease and aortic aneurysm.

In patients with AVD of different severities or TAA, the investigators will collect informations from echocardiography and/or cardiac magnetic resonance imaging, KCG recordings, phonocardiography (PCG) recordings, and video recordings. Researchers will also compare subjects without any AVD nor TAA to better understand these effects on KCG, PCG and video signal.

详细描述

Aortic valve disease (AVD) is a common but under-diagnosed disease which can cause various cardiovascular complications. AVD, including aortic stenosis and aortic regurgitation, can be associated with dilatation of the ascending thoracic aorta as a result of hemodynamic mechanisms and genetic predisposition. In the assessment of an AVD, it is important to consider if it is associated with a thoracic aortic aneurysm (TAA), and vice versa.

The prevalence of TAA in the general population is difficult to assess because most patients are asymptomatic, and their lethal complications (rupture and dissections) are often misdiagnosed as myocardial infarctions. The insidious evolution of aortic pathology motivates physicians to make the diagnosis as early as possible before the appearance of irreversible lesions causing significant morbidity and mortality. Traditional semiology can be useful for AVD screening (auscultation of a murmur, or observation of some visible semiological signs). However, it relies on the proficiency of care providers and may not allow a timely diagnosis of less severe forms of the disease. Moreover, imaging techniques used in current clinical practice are not appropriate for the organization of large-scale screening in asymptomatic patients. In addition, none of these techniques are accessible for the people living far away from a healthcare institution.

Kinocardiography (KCG) is a portable measurement technique developed to estimate cardiac mechanical performance by studying the vibrations produced by myocardial contraction during each heartbeat and transmitted to the body surface. Signals are recorded thanks to a sensor placed on the sternum, another sensor placed on the lower back and electrocardiogram electrodes.

Smartphones are equipped with accelerometers and gyroscope, and may allow anyone to measure their own cardiac mechanical function similarly to KCG.

Phonocardiography (PCG) enables the detailed recording and analysis of heart sounds produced by the blood flow during the opening and closing of heart valves thanks to a microphone. It allows the extraction of heart sound information that reveals valvular diseases, such as the timing of heart valve closure, the frequency content of heart sounds, and the presence of diastolic or systolic murmurs.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • "Interventional treatment" group
  • Adults (>18 y)
  • Interventional treatment indication for severe AVD and/or severe TAA, as decided by the Heart Team
  • "Aortic valve disease of different severities" group
  • Adults (>18y)
  • Aortic stenosis and/or aortic regurgitation and/or bicuspidy of different severities confirmed by echocardiography and/or cardiac MRI
  • "Control" group : - Adults (>18 y) appariated with the participants of other groups according to their age, sex, body surface area and LVEF

排除标准

  • Any severe rhythm disorder such as frequent ventricular extrasystoles, atrial tachyarrhythmias
  • Subject's disabilty to give consent
  • Subjects suffering from aortic valve disease or thoracic aortic aneurysm will be excluded from the "control" group.

研究组 & 干预措施

Interventional treatment

Patients with severe aortic valve disease or thoracic aortic aneurysm in whom interventional treatment has been previously decided by the Heart Team (i.e. the multidisciplinary team of cardiologists and cardiac surgeons treating the patient, independently of the research team) Patients with different severities of AVD or TAA, and healthy subjects. The KCG measurements and video recordings are consecutive to an echocardiography or cardiac MRI, and will be carried out in Erasme hospital.

干预措施: Kinocardiography (Diagnostic Test)

Aortic valve disease of different severities

Patients with aortic stenosis and/or aortic regurgitation and/or bicuspidy of different severities. The KCG measurements consecutive to the echocardiography and/or cardiac MRI will be carried out during their clinical management in Erasme hospital.

干预措施: Kinocardiography (Diagnostic Test)

Control

Subjects matched to the two other groups according to their age, gender, body surface area and left ventricular ejection fraction (LVEF), without AVD or TAA. The KCG measurements will be made immediately after the echocardiography and/or MRI in Erasme hospital.

干预措施: Kinocardiography (Diagnostic Test)

结局指标

主要结局

Understand and assess the complex mechanisms underlying the modifications of KCG signals in patients with AVD and/or TAA

时间窗: 12 months

Correlation between KCG parameters and imaging parameters (echocardiography, 4D flow MRI)

次要结局

  • Comparing KCG to clinical assessment(18 months)
  • Asses the clinical application of KCG to diagnose AVD and TAA(18 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Elza Abdessater

Medical doctor at Erasme University Hospital

Erasme University Hospital

研究点 (2)

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