Aortopathy Relationship To Imagery and Kinocardiography Features (ARTIK)

NCT06286358 | Recruiting DMC

• 1 other identifier: P2023/346 / CCB : B40620230001
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Aortic Valve Disease; Aortic Aneurysm

Keywords

Aortic stenosis; Aortic regurgitation; Thoracic aortic aneurysm; Kinocardiography

Outcome Measures

Primary Outcomes (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)

  12 months

Secondary Outcomes (2)

• Comparing KCG to clinical assessment

  18 months

• Asses the clinical application of KCG to diagnose AVD and TAA

  18 months

Study Arms (3)

Interventional treatment

Patients 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.

Diagnostic Test: Kinocardiography

Aortic valve disease of different severities

Patients 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.

Diagnostic Test: Kinocardiography

Control

Subjects 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.

Diagnostic Test: Kinocardiography

Interventions

Kinocardiography DIAGNOSTIC_TEST

Technology Measuring Cardiac Mechanical Activity Via Accelerometers and Gyroscopes

Aortic valve disease of different severities; Control; Interventional treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• "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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Université Libre de Bruxelles: lead
• Erasme University Hospital: collaborator

Study Sites (1)

Erasme hospital

Brussels, 1070, Belgium

RECRUITING

MeSH Terms

Conditions

Aortic Valve Disease; Aortic Aneurysm; Aortic Valve Stenosis; Aortic Valve Insufficiency; Aortic Aneurysm, Thoracic

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Aneurysm; Vascular Diseases; Aortic Diseases; Ventricular Outflow Obstruction

Central Study Contacts

Elza Abdessater, MD

CONTACT

2 555 32 75; elza.abdessater@ulb.be

Philippe van de Borne, MD, PhD

CONTACT

2 555 39 60; philippe.vandeborne@hubruxelles.be

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical doctor at Erasme University Hospital

Study Record Dates

• First Submitted: February 22, 2024
• First Posted: February 29, 2024
• Study Start: March 7, 2024
• Primary Completion (Estimated): October 5, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)