Clinical trial NCT06008600: KINO-DYSPNEA: Validation of Kinocardiography to Distinguish Dyspnea of Cardiac Origin From Others
Official title: KINO-DYSPNEA: Validation of Kinocardiography to Distinguish Dyspnea of Cardiac Origin From Others
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dyspnea
Lead sponsor: Centre Hospitalier Universitaire de Tivoli
Sponsor class: OTHER
Collaborators: name: HeartKinetics
First posted: 2023-08-23
Enrollment: 528
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Any adult presenting with dyspnea to the emergency department or cardiology consultation.

Brief summary: Seismocardiography (SCG) measures the thoracic vibrations caused by the cardiac contraction and ejection of blood into the great vessels. Current smartphones with gyroscopes and accelerometers can measure these vibrations. Based on these components we measure and quantify the cardiac kinetic energy (kinocardiography) in order to differentiate dyspnea of cardiac origin from dyspnea of other origin. The study is conducted in an emergency service where a smartphone performs the measurement during 3 minutes. The results of the kinocardiography-based classification are then compared to the final diagnosis made by a physician. Currently, 235 patients have been included in the clinical study since May 2022. This rapid and non-invasive measurement allows the aid-to-diagnosis of heart failure without being influenced by other factors like the renal function for example that can be NT-pro BNP blood marker.


Eligibility criteria: Inclusion Criteria:

* Dyspnea.
* Adults aged above 18 years old.

Exclusion Criteria:

* Patients younger than 18 years old.

Primary outcomes:
measure: Evaluate the ability of the Kinocardiography technique to discriminate cardiac caused dyspnea from others.
timeFrame: 18 months
Secondary outcomes:
measure: Open retrospective exploratory study to validate the physiological interpretation of Kinocardiography in a clinical environment.
timeFrame: 18 months
Other outcomes:
Locations:
city: La Louvière
country: Belgium
facility: CHU Tivoli
state: Hainaut
Study officials:
References:
citation: Hossein A, Rabineau J, Gorlier D, Pinki F, van de Borne P, Nonclercq A, Migeotte PF. Effects of acquisition device, sampling rate, and record length on kinocardiography during position-induced haemodynamic changes. Biomed Eng Online. 2021 Jan 6;20(1):3. doi: 10.1186/s12938-020-00837-5.
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.
citation: Morra S, Pitisci L, Su F, Hossein A, Rabineau J, Racape J, Gorlier D, Herpain A, Migeotte PF, Creteur J, van de Borne P. Quantification of Cardiac Kinetic Energy and Its Changes During Transmural Myocardial Infarction Assessed by Multi-Dimensional Seismocardiography. Front Cardiovasc Med. 2021 Mar 8;8:603319. doi: 10.3389/fcvm.2021.603319. eCollection 2021.
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.