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

Sponsor
Centre Hospitalier Universitaire de Tivoli (Other)
Overall Status
Recruiting
CT.gov ID
NCT06008600
Collaborator
(none)
100
1
19.4
5.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Kinocardiography

Study Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
100 participants
Observational Model:
Other
Time Perspective:
Cross-Sectional
Official Title:
KINO-DYSPNEA: Validation of Kinocardiography to Distinguish Dyspnea of Cardiac Origin From Others
Actual Study Start Date :
May 19, 2022
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Outcome Measures

Primary Outcome Measures

  1. Evaluate the ability of the Kinocardiography technique to discriminate cardiac caused dyspnea from others. [18 months]

    Area under the receiver operating characteristic curve (AUROC), negative predictive value (NPV) and specificity, with two-sided 95% CIs.

Secondary Outcome Measures

  1. Open retrospective exploratory study to validate the physiological interpretation of Kinocardiography in a clinical environment. [18 months]

    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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Inclusion Criteria:
  • Dyspnea.

  • Adults aged above 18 years old.

Exclusion Criteria:
  • Patients younger than 18 years old.

Contacts and Locations

Locations

Site City State Country Postal Code
1 CHU Tivoli La Louvière Hainaut Belgium 7100

Sponsors and Collaborators

  • Centre Hospitalier Universitaire de Tivoli

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Centre Hospitalier Universitaire de Tivoli
ClinicalTrials.gov Identifier:
NCT06008600
Other Study ID Numbers:
  • P2021/414 / B4062021000223
First Posted:
Aug 23, 2023
Last Update Posted:
Aug 23, 2023
Last Verified:
Aug 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 23, 2023