Aortopathy Relationship To Imagery and Kinocardiography Features (ARTIK) — ARTIK  

Aortic Valve Disease Clinical Trial

Official title: Impact of Aortic Valve Disease and Thoracic Aortic Aneurysm on Kinocardiographic Signals

Status Recruiting

Clinical Trial Summary

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 us 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 and KCG recordings. Researchers will also compare subjects without any AVD nor TAA to better understand these effects on KCG.

Clinical Trial Description

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. 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.

The primary objective of this prospective observational study is to better understand and assess KCG signals modifications due to aortic valve disease (AVD) and/or thoracic aortic aneurysm (TAA). It will be possible thanks to imaging techniques such as 4D flow MRI. The secondary objective of our study is to evaluate if KCG can be used for the diagnostic and characterization of AVD, and then if it may be done with a smartphone.

The possible participants will be identified, according to inclusion/exclusion criteria. Informed consent will be given to the patients. Immediately after the echocardiography and/or the cardiac MRI, the investigators ll record KCG data, and then perform similar measurements using a smartphone placed on the torso. For patients undergoing aortic valve replacement or thoracic aortic aneurysm surgery, the investigators will also perform the same KCG measurements post-operatively, immediately after de post-operative cardiac MRI. ;

Related Conditions & MeSH terms

• Aneurysm
• Aortic Aneurysm
• Aortic Valve Disease

• NCT number: NCT06286358
• Study type: Observational
• Source: Université Libre de Bruxelles
• Contact: Elza Abdessater, MD
• Phone: 2 555 32 75
• Email: elza.abdessater@ulb.be
• Status: Recruiting
• Start date: March 7, 2024
• Completion date: September 30, 2025