Aortopathy Relationship To Imagery and Kinocardiography Features (ARTIK)

Aortic Valve Disease Clinical Trial

— ARTIK  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06286358
• Other study ID #: P2023/346 / CCB : B40620230001
• Status: Recruiting
• Start date: March 7, 2024
• Est. completion date: September 30, 2025

Study information

• Verified date: March 2024
• Source: Université Libre de Bruxelles
• Contact: Elza Abdessater, MD
• Phone: 2 555 32 75
• Email: elza.abdessater[@]ulb.be
• Is FDA regulated: No
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: September 30, 2025
• Est. primary completion date: March 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Aneurysm
• Aortic Aneurysm
• Aortic Valve Disease

Intervention

Diagnostic Test:
• Kinocardiography
Technology Measuring Cardiac Mechanical Activity Via Accelerometers and Gyroscopes

Locations

Country	Name	City	State
Belgium	Erasme hospital	Brussels

Sponsors (2)

Lead Sponsor	Collaborator
Université Libre de Bruxelles	Erasme University Hospital

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	12 months
Secondary	Comparing KCG to clinical assessment	Correlation between KCG parameters, phonocardiography and clinical semiological signs	18 months
Secondary	Asses the clinical application of KCG to diagnose AVD and TAA	With a dedicated device and with a smartphone	18 months