Validation of Kinocardiography, a New Technology Measuring Cardiac Mechanical Activity Via Accelerometers and Gyroscopes

Free University of Brussels (ULB)

Status: Completed

Conditions: Hypertension; Atrial Fibrillation; Heart Failure

Treatments: Device: Kinocardiograph

Study type: Observational

Funder types: Other

Identifiers

NCT04772807

P2020/502

Sponsor study reference (Other Identifier)

Details and patient eligibility

About

Kinocardiographic measures mechanical and electrical function of the heart. The proposed solution is based on measurements of body vibrations. By measuring these movements on the surface of the body, it is possible to deduce, taking into account the individual's weight and size, the quality of the heartbeat that caused this vibration. The technique developed consists of a device measuring these vibrations at two places in the body: on the torso (Seismocardiography) and on the lower back (Ballistocardiography). The first measurement is a reflection of the local strength of the heartbeat as well as the transmission of blood to the body's main artery, the aorta. The second measurement, in the lower back, is the result of the contraction and movement of blood within the arterial system. Based on these two measurements, the energy produced by the heart and transmitted to the torso or the whole body is calculated. The energy over an entire cardiac cycle and the distribution of that energy within a heartbeat are used to characterize the mechanical function of the heart.

Clinical studies carried out previously have demonstrated the repeatability of kinocardiographic measurements (KCG) and their robustness with respect to the use of different sensors.

KCG measurements also showed a high sensitivity (> 94%) to different hemodynamic states induced by the injection of active inotropic agents, i.e. dobutamine also used as a treatment for heart failure in an advanced stage. In a randomized, double-blind, cross-over study controlled by Placebo, these measurements showed a strong correlation (r = 0.8, p <0.0001) with cardiac output measured by echocardiography. The technique has also demonstrated its ability to track changes in cardiac mechanical function during expiratory voluntary apnea.

KCG measurements were also evaluated during a micro-gravity simulation in Bedrest on 23 healthy volunteers. The measurements tracked cardiac deconditioning in the control group compared to the exercise group similarly to cardiac MRI measurements. Subsequently, KCG metrics showed an ability to distinguish reduced ejection fraction (HFrEF) heart failure patients from non-insufficient patients. These latest results also showed that the chest sensor alone was sufficient to separate HFrEF patients from normative patients, laying the foundation for possible use of the smartphone alone.

The prototype of a mobile application, named OKCARDIO, makes it possible to take measurements perfectly similar to the Kino thoracic sensor, but to date have never been used it in a clinical study. Such a tool would allow anyone with a smartphone-type mobile phone to measure their cardiac mechanical function themselves and make it available to the attending physician.

Enrollment: 220 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adults aged above 18 years old.
• BMI (Body Mass Index) is below 50 kg/m2.
• Fit in one of the groups

Exclusion criteria

• Patients younger than 18 years old.
• BMI (Body Mass Index) higher than 50 kg/m2.

Trial design

220 participants in 8 patient groups

Healthy

Treatment:

Device: Kinocardiograph

Patients infected by COVID- 19 with no symptoms

Treatment:

Device: Kinocardiograph

Patients infected by COVID- 19 with symptoms

Treatment:

Device: Kinocardiograph

Patients diagnosed with atrial fibrillation

Treatment:

Device: Kinocardiograph

Hypertensive patients

Treatment:

Device: Kinocardiograph

Heart failure patients, EF < 40%

Treatment:

Device: Kinocardiograph

Heart failure patients, EF > 40% and < 60%

Treatment:

Device: Kinocardiograph

Heart failure patients, EF > 60%

Treatment:

Device: Kinocardiograph