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

NCT ID: NCT04772807

Last Updated: 2024-02-22

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 220 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-02-05
• Study Completion Date: 2024-01-31

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.

Conditions

Atrial Fibrillation; Hypertension; Heart Failure

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Healthy

Kinocardiograph

Intervention Type: DEVICE

Measure with the Kinocardiograph device and the Okcardio application installed on a smartphone

Patients infected by COVID- 19 with no symptoms

Kinocardiograph

Intervention Type: DEVICE

Measure with the Kinocardiograph device and the Okcardio application installed on a smartphone

Patients infected by COVID- 19 with symptoms

Kinocardiograph

Intervention Type: DEVICE

Measure with the Kinocardiograph device and the Okcardio application installed on a smartphone

Patients diagnosed with atrial fibrillation

Kinocardiograph

Intervention Type: DEVICE

Measure with the Kinocardiograph device and the Okcardio application installed on a smartphone

Hypertensive patients

Kinocardiograph

Intervention Type: DEVICE

Measure with the Kinocardiograph device and the Okcardio application installed on a smartphone

Heart failure patients, EF < 40%

Kinocardiograph

Intervention Type: DEVICE

Measure with the Kinocardiograph device and the Okcardio application installed on a smartphone

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

Kinocardiograph

Intervention Type: DEVICE

Measure with the Kinocardiograph device and the Okcardio application installed on a smartphone

Heart failure patients, EF > 60%

Kinocardiograph

Intervention Type: DEVICE

Measure with the Kinocardiograph device and the Okcardio application installed on a smartphone

Interventions

Kinocardiograph

Measure with the Kinocardiograph device and the Okcardio application installed on a smartphone

Intervention Type: DEVICE

Other Intervention Names

OKCARDIO smart application

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Erasme University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Philippe van de Borne, Professor

Role: PRINCIPAL_INVESTIGATOR

Hospital Erasme

Locations

Erasme Hospital

Brussels, , Belgium

Countries

Belgium

References

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.

Reference Type: BACKGROUND

PMID: 31324831 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 33077727 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 33530417 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 33436841 (View on PubMed)

Other Identifiers

Sponsor study reference

Identifier Type: OTHER

Identifier Source: secondary_id

P2020/502

Identifier Type: -

Identifier Source: org_study_id