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Aortopathy Relationship To Imagery and Kinocardiography Features (ARTIK)

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06286358
Acronym
ARTIK
Enrollment
180
Registered
2024-02-29
Start date
2024-03-07
Completion date
2026-12-30
Last updated
2026-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic Aneurysm, Aortic Valve Disease

Keywords

Aortic stenosis, Aortic regurgitation, Thoracic aortic aneurysm, Kinocardiography

Brief 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 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.

Detailed 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 (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.

Interventions

DIAGNOSTIC_TESTKinocardiography

Technology Measuring Cardiac Mechanical Activity Via Accelerometers and Gyroscopes

Sponsors

Université Libre de Bruxelles
Lead SponsorOTHER
Erasme University Hospital
CollaboratorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Understand and assess the complex mechanisms underlying the modifications of KCG signals in patients with AVD and/or TAA12 monthsCorrelation between KCG parameters and imaging parameters (echocardiography, 4D flow MRI)

Secondary

MeasureTime frameDescription
Comparing KCG to clinical assessment18 monthsCorrelation between KCG parameters, phonocardiography, semiological signs and video signals
Asses the clinical application of KCG to diagnose AVD and TAA18 monthsWith a dedicated device and with a smartphone

Countries

Belgium

Contacts

CONTACTElza Abdessater, MD
elza.abdessater@ulb.be2 555 32 75
CONTACTPhilippe van de Borne, MD, PhD
philippe.vandeborne@hubruxelles.be2 555 39 60

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 2, 2026