Cardiac Linear and Torsional Contractility Measurements With a New Technology: Multi Dimensional Kineticardiography

Study Overview
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Brief Summary
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This study aims to validate the possibility to track cardiac contractility changes with a new technology called 'Heart Kinetic' (HK). HK measurements will be realized and compared echocardiography.

Official Title
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Validation Study of Cardiac Linear and Torsional Contractility Measurements With a New Technology: Multi Dimensional Kineticardiography (MKCG)

Conditions
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Healthy

Intervention / Treatment
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* Device: Cardiac contractility assessments with Kino-cardiograph
* Device: Cardiac assessment repeatability with Kino-cardiograph


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult between 18 and 50 years old. Healthy without medical cardiac conditions history. Non smoker. Does not take any drugs or medications. Does not participate in other clinical study or trial. BMI (Body Mass Index) in between 20 and 25 kg/m2. Exclusion Criteria: Being younger than 18 or older than 50 years old. Having had previous cardiac conditions or present disease. Being a regular smoker. Taking any drugs or medications Taking part in another clinical study or trial. BMI (Body Mass Index) lower than 20 or higher than 25 kg/m2.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Double blind randomized crossover active vs placebo
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: repeatability measures<br>In this arm, healthy subjects will undergo repeated measures at different times of the day. | Device: Cardiac assessment repeatability with Kino-cardiograph<br>* Cardiac contractility will be assessed with Kino-cardiograph device only, at different times of the day to assess the repeatability of the measures.<br>|
| Experimental: Contractility changes measures<br>In this arm, healthy subjects will have their cardiac contractility increased in a controlled way and assessed with both HK and echocardiography. | Device: Cardiac contractility assessments with Kino-cardiograph<br>* Cardiac contractility will be assessed with Kino-cardiograph device. Echocardiography will also be used for the experimental arm<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HK reproducibility validation | Validate the reproducibility of HK measurements in a clinical environment. | day 1 | 
| Cardiac contractility tracking with HK | Proof that the HK technology can track physiological cardiac changes while comparing with gold standard echocardiography and inducing a cardiac contractility change with dobutamine infusion. | day 1 |