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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-27

Study Completion Date

2018-02-01

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.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Double blind randomized crossover active vs placebo

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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repeatability measures

In this arm, healthy subjects will undergo repeated measures at different times of the day.

Group Type SHAM_COMPARATOR

Cardiac assessment repeatability with Kino-cardiograph

Intervention Type DEVICE

Cardiac contractility will be assessed with Kino-cardiograph device only, at different times of the day to assess the repeatability of the measures.

Contractility changes measures

In this arm, healthy subjects will have their cardiac contractility increased in a controlled way and assessed with both HK and echocardiography.

Group Type EXPERIMENTAL

Cardiac contractility assessments with Kino-cardiograph

Intervention Type DEVICE

Cardiac contractility will be assessed with Kino-cardiograph device. Echocardiography will also be used for the experimental arm

Interventions

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Cardiac contractility assessments with Kino-cardiograph

Cardiac contractility will be assessed with Kino-cardiograph device. Echocardiography will also be used for the experimental arm

Intervention Type DEVICE

Cardiac assessment repeatability with Kino-cardiograph

Cardiac contractility will be assessed with Kino-cardiograph device only, at different times of the day to assess the repeatability of the measures.

Intervention Type DEVICE

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes