Clinical trial NCT04772807: Validation of Kinocardiography, a New Technology Measuring Cardiac Mechanical Activity Via Accelerometers and Gyroscopes
Official title: Validation of Kinocardiography, a New Technology Measuring Cardiac Mechanical Activity Via Accelerometers and Gyroscopes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Hypertension
Heart Failure
Lead sponsor: Erasme University Hospital
Sponsor class: OTHER
First posted: 2021-02-26
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients in the ambulatory routine of the cardiology department at the Erasme hospital

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Feasibility of KCG measurement performed by the patients themselves
timeFrame: 12 weeks
measure: Validation of KCG parameters by comparisons from different modalities: Kinocardiograph device and OKCARDIO smartphone application.
timeFrame: Through study completion, an average of 1 year
measure: Repeatability of OKCARDIO smartphone application recorded by an experimented operator and by the patient
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: Compliance percentage of patients measuring KCG at home with the OKCARDIO smartphone application or the Kinocardiograph device.
timeFrame: 12 weeks
measure: Mean and interquartile ranges of KCG derived HRV over the observation period.
timeFrame: Through study completion, an average of 1 year
measure: Mean and interquartile ranges of KCG derived HR over the observation period.
timeFrame: Through study completion, an average of 1 year
measure: Adverse events related to the use of the Kinocardiograph devices and/or OKCARDIO smartphone. Count of adverse events.
timeFrame: Through study completion, an average of 1 year
measure: Mean and interquartile ranges of KCG parameters (Kinetic Energy, namely iK) over the observation period.
timeFrame: Through study completion, an average of 1 year
measure: Build a predictive score on a selection of several kinocardiography parameters based on machine learning algorithms with the aim to sort patients according to their pathological status.
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Erasme Hospital
Study officials:
affiliation: Hospital Erasme
name: Philippe van de Borne, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hossein A, Mirica DC, Rabineau J, Rio JID, Morra S, Gorlier D, Nonclercq A, van de Borne P, Migeotte PF. Accurate Detection of Dobutamine-induced Haemodynamic Changes by Kino-Cardiography: A Randomised Double-Blind Placebo-Controlled Validation Study. Sci Rep. 2019 Jul 19;9(1):10479. doi: 10.1038/s41598-019-46823-3.
citation: Rabineau J, Hossein A, Landreani F, Haut B, Mulder E, Luchitskaya E, Tank J, Caiani EG, van de Borne P, Migeotte PF. Cardiovascular adaptation to simulated microgravity and countermeasure efficacy assessed by ballistocardiography and seismocardiography. Sci Rep. 2020 Oct 19;10(1):17694. doi: 10.1038/s41598-020-74150-5.
citation: Hossein A, Rabineau J, Gorlier D, Del Rio JIJ, van de Borne P, Migeotte PF, Nonclercq A. Kinocardiography Derived from Ballistocardiography and Seismocardiography Shows High Repeatability in Healthy Subjects. Sensors (Basel). 2021 Jan 26;21(3):815. doi: 10.3390/s21030815.
citation: Morra S, Hossein A, Rabineau J, Gorlier D, Racape J, Migeotte PF, van de Borne P. Assessment of left ventricular twist by 3D ballistocardiography and seismocardiography compared with 2D STI echocardiography in a context of enhanced inotropism in healthy subjects. Sci Rep. 2021 Jan 12;11(1):683. doi: 10.1038/s41598-020-79933-4.