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Validation of Kinocardiography, New Technology for Cardiac Linear and Torsional Contractility Measurement, to Assess Heart Failure Patient With Low Ejection Fraction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03157115
Recruitment Status : Active, not recruiting
First Posted : May 17, 2017
Last Update Posted : October 24, 2022
Sponsor:
Information provided by (Responsible Party):
Dr Marielle Morissens, Brugmann University Hospital

Brief Summary:

Measuring cardiac contractility is commonly realized with gold standard echocardiography or MRI. Portable devices to measure this contractility are not available as for rhythm and electric function assessment. The new Kinocardiography technology could provide a non invasive and portable tool to measure contractility.

This device records the electric and mechanic function of the heart simultaneously. With electrodes and adequate electronics, ECG is recorded. 6 degrees of freedom accelerometers are also included in the device to measure the micro accelerations of the body at the body surface when the device is placed on the skin. Using physics principles and adequate calibration, those accelerations allow the investigators to calculate parameters such as kinetics energies related to cardiac contractility. Kinocardiography is a non invasive and portable technology.


Condition or disease Intervention/treatment Phase
Impaired Left Ventricular Ejection Fraction Device: Kinocardiography Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 130 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Validation of Kinocardiography, New Technology for Cardiac Linear and Torsional Contractility Measurement, to Assess Heart Failure Patient With Low Ejection Fraction
Actual Study Start Date : July 1, 2017
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Experimental: Impaired left ventricular ejection fraction
Patients with reduced left ventricular ejection fraction (< 50 %)
Device: Kinocardiography

This device records the electric and mechanic function of the heart. With electrodes and adequate electronics, ECG is recorded. 6 degrees of freedom accelerometers are also included in the device to measure the micro accelerations of the body at the body surface when the device is placed on the skin. Using physics principles and adequate calibration, those accelerations allow us to calculate parameters such as kinetics energies related to cardiac contractility.

During a standard echocardiography appointment for a patient suffering from a cardiovascular condition with/without heart failure, the cardiologist will monitor the heart of the patient with the Kino device (examination lasting a few minutes with the patient lying down on a bed). Data will be matched between the control group and the experimental group.


Active Comparator: Control
Patients with a normal left ventricular ejection fraction (≥ 50 %), without heart failure. The patients from the reduced left ventricular ejection fraction group will be matched with patients from the control group for sex, age, BMI and cardiovascular treatment.
Device: Kinocardiography

This device records the electric and mechanic function of the heart. With electrodes and adequate electronics, ECG is recorded. 6 degrees of freedom accelerometers are also included in the device to measure the micro accelerations of the body at the body surface when the device is placed on the skin. Using physics principles and adequate calibration, those accelerations allow us to calculate parameters such as kinetics energies related to cardiac contractility.

During a standard echocardiography appointment for a patient suffering from a cardiovascular condition with/without heart failure, the cardiologist will monitor the heart of the patient with the Kino device (examination lasting a few minutes with the patient lying down on a bed). Data will be matched between the control group and the experimental group.





Primary Outcome Measures :
  1. Total heart kinetic energy [ Time Frame: 1 hour ]
    Computed according to the micro accelerations of the body at the body surface. The hypothesis is that the investigators will observe a lower total heart kinetic energy for the group with impaired left ventricular ejection fraction in comparison to a paired control patient group.


Secondary Outcome Measures :
  1. Ratio of torsional kinetic energy over total kinetic energy [ Time Frame: 1 hour ]
    Computed according to the micro accelerations of the body at the body surface. The hypothesis is that the investigators will observe a lower ratio of torsional kinetic energy over total kinetic energy for the impaired left ventricular ejection fraction group in comparison to a paired control group.



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Ages Eligible for Study:   20 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Control group: Left Ventricle Ejection Fraction ≥ 50 %
  • Heart failure patients: Left Ventricle Ejection Fraction < 50 %

Exclusion Criteria:

  • Intracardiac devices and arrhythmia at the time of assessment
  • Participates in other clinical study or trial.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03157115


Locations
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Belgium
CHU Brugmann
Brussels, Belgium, 1020
Sponsors and Collaborators
Brugmann University Hospital
Investigators
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Principal Investigator: Eva De Keyzer, MD CHU Brugmann
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Responsible Party: Dr Marielle Morissens, MD, Brugmann University Hospital
ClinicalTrials.gov Identifier: NCT03157115    
Other Study ID Numbers: CHUB-Kino-HFrEF
First Posted: May 17, 2017    Key Record Dates
Last Update Posted: October 24, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr Marielle Morissens, Brugmann University Hospital:
Kinocardiography
Cardiac contractility
Heart kinetic energy
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases