KINO-DYSPNEA: Validation of Kinocardiography to Distinguish Dyspnea of Cardiac Origin From Others

Dyspnea Clinical Trial

Official title:

KINO-DYSPNEA: Validation of Kinocardiography to Distinguish Dyspnea of Cardiac Origin From Others

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06008600
• Other study ID #: P2021/414 / B4062021000223
• Status: Recruiting
• Start date: May 19, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: August 2023
• Source: Centre Hospitalier Universitaire de Tivoli
• Contact: Tuan Long Tran, Doctor
• Phone: +32 64 27 48 61
• Email: ttran[@]chu-tivoli.be
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Dyspnea.

• Adults aged above 18 years old.

Exclusion Criteria:

• Patients younger than 18 years old.

Related Conditions & MeSH terms

• Dyspnea

Intervention

Device:
• Kinocardiography
Smartphone (application with seismocardiography)

Locations

Country	Name	City	State
Belgium	CHU Tivoli	La Louvière	Hainaut

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Tivoli

Country where clinical trial is conducted

Belgium, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate the ability of the Kinocardiography technique to discriminate cardiac caused dyspnea from others.	Area under the receiver operating characteristic curve (AUROC), negative predictive value (NPV) and specificity, with two-sided 95% CIs.	18 months
Secondary	Open retrospective exploratory study to validate the physiological interpretation of Kinocardiography in a clinical environment.	Establish a link between cardiac kinetic energy distribution in the cardiac cycle between major active clinical syndromes that may be concomitant in the field of cardiac disorders (hypertension, atrial fibrillation, ischemia, valvulopathy, heart-failure,…) and pulmonary (asthma, infection,..). These clinical diagnoses are supported by the physical examination and the patient's medical record at inclusion, with the aid of a measurement of troponin and NTBNP	18 months