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NCT Number: NCT06286358

Aortopathy Relationship To Imagery and Kinocardiography Features (ARTIK)

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Erasme hospital

Brussels, 1070, Belgium

Location status: Recruiting

Location contact

Elza Abdessater, MD

SUB_INVESTIGATOR

Philippe van de Borne, MD, PhD

CONTACT

[email protected]

2 555 39 60 ext. +32

Philippe van de Borne, MD, PhD

PRINCIPAL_INVESTIGATOR

About this study

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.

Video image processing by Remote photoplethysmography (RPPG) or by Eulerian video magnification (EVM) allow the analysis of color changes and movements, invisible to the naked eye.

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, and thanks to a comparison with PCG. The secondary objective of our study is to evaluate if a smartphone can be used for the diagnostic and characterization of AVD, using KCG, PCG or video image processing.

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 will record KCG and PCG data, and then perform similar measurements using a smartphone placed on the torso. These measurements are followed by two short video recordings of 30 seconds, simultaneously to a KCG recording. For patients undergoing aortic valve replacement or thoracic aortic aneurysm surgery, the investigators will also perform the KCG measurements post-operatively, immediately after de post-operative cardiac MRI and/or echocardiography.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • "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

Exclusion criteria

  • 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.

Treatment and study plan

Kinocardiography

Diagnostic Test

Technology Measuring Cardiac Mechanical Activity Via Accelerometers and Gyroscopes

Primary outcomes

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

    Time frame: 12 months

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

Secondary outcomes

  1. Comparing KCG to clinical assessment

    Time frame: 18 months

    Correlation between KCG parameters, phonocardiography, semiological signs and video signals

  2. Asses the clinical application of KCG to diagnose AVD and TAA

    Time frame: 18 months

    With a dedicated device and with a smartphone

Study contacts

Contact information is provided by the study sponsor or research team.

Elza Abdessater, MD

CONTACT

[email protected]

2 555 32 75 ext. +32

Philippe van de Borne, MD, PhD

CONTACT

[email protected]

2 555 39 60 ext. +32

Sponsors and collaborators

Lead sponsor

Université Libre de Bruxelles

Other

Collaborators

  • Erasme University Hospital

Registry information

Official study title

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

Acronym: ARTIK

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Feb 29, 2024
Registry last updated
May 1, 2026

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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