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Aortic Valve DiseaseARTIKNCT06286358

Aortopathy Relationship To Imagery and Kinocardiography Features (ARTIK)

An observational study of Aortic Valve Disease and Aortic Aneurysm, run by Université Libre de Bruxelles at 1 site in Belgium.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Aortic Valve Disease, Aortic Aneurysm
What is being tested?
Kinocardiography
How many people
180 participants
Where
1 siteBelgium
Study dates
7 Mar 2024to 30 Dec 2026
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Both inpatients and outpatients may be included in "interventional treatment" group and "aortic valve disease of different severities" group. "Control" group may include inpatients, outpatients and healthy subjects.

Who may be able to join

  • "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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Philippe van de Borne, MD, PhD contact

2 555 39 60 ext. +32

philippe.vandeborne@hubruxelles.be

Belgium1 site, 1 recruiting
  • Erasme hospital

    Brussels, 1070

    Philippe van de Borne, MD, PhD, 2 555 39 60 ext. +32, philippe.vandeborne@hubruxelles.be

    Philippe van de Borne, MD, PhD

    Recruiting

Other trials in Belgium

About this study

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

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.

Read the 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.

Being tested
Kinocardiography
Keywords
Aortic stenosis, Aortic regurgitation, Thoracic aortic aneurysm, Kinocardiography
Medical subject headings
Aortic Valve Disease, Aortic Aneurysm, Aortic Valve Stenosis, Aortic Valve Insufficiency, Aortic Aneurysm, Thoracic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • KinocardiographyDiagnostic test

    Technology Measuring Cardiac Mechanical Activity Via Accelerometers and Gyroscopes

Study groups in NCT06286358
Study groupRoleWhat they receive
Interventional treatmentPatients 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.
Receives: Diagnostic Test: Kinocardiography
Aortic valve disease of different severitiesPatients 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.
Receives: Diagnostic Test: Kinocardiography
ControlSubjects 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.
Receives: Diagnostic Test: Kinocardiography

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

    Measured: 12 months

Secondary outcomes (2)
  1. Comparing KCG to clinical assessment

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

    Measured: 18 months

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

    With a dedicated device and with a smartphone

    Measured: 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Feb 2024
  2. Study start7 Mar 2024
  3. Primary completion5 Oct 2026 (estimated)
  4. Study completion30 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
180 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06286358
Sponsor's protocol ID
P2023/346 / CCB : B40620230001
Acronym
ARTIK
Status last verified
Apr 2026
First submitted
22 Feb 2024
Last updated
1 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Aortic Valve Disease and Aortic Aneurysm, run by Université Libre de Bruxelles at 1 site in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Elza Abdessater, MD (2 555 32 75 ext. +32, elza.abdessater@ulb.be), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Understand and assess the complex mechanisms underlying the modifications of KCG signals in patients with AVD and/or TAA (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.

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