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

NCT06008600 | Completed DMC

• 1 other identifier: P2021/414 / B4062021000223
• Study Type: observational
• Target: 528
• Locations: 1 country
• Sites: 1

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.

Conditions

Dyspnea

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Open retrospective exploratory study to validate the physiological interpretation of Kinocardiography in a clinical environment.

  18 months

Interventions

Kinocardiography DEVICE

Smartphone (application with seismocardiography)

Also known as: NT-pro BNP blood measurement

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Any adult presenting with dyspnea to the emergency department or cardiology consultation.

You may qualify if:

• Dyspnea.
• Adults aged above 18 years old.

You may not qualify if:

• Patients younger than 18 years old.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Tivoli: lead
• HeartKinetics: collaborator

Study Sites (1)

CHU Tivoli

La Louvière, Hainaut, 7100, Belgium

Location

Related Publications (4)

• 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.

  PMID: 33407507 BACKGROUND

• 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.

  PMID: 33436841 BACKGROUND

• 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.

  PMID: 33763456 BACKGROUND

• 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.

  PMID: 33530417 BACKGROUND

MeSH Terms

Conditions

Dyspnea

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2023
• First Posted: August 23, 2023
• Study Start: May 19, 2022
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: January 22, 2025

Record last verified: 2025-01

Locations

BE (1)