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

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Device: Cardiac assessment repeatability with Kino-cardiograph; Device: Cardiac contractility assessments with Kino-cardiograph

• Registration Number: NCT03107351
• Lead Sponsor: Erasme University Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-02-22
• Study Start: 2017-03-27
• Study First Submitted QC: 2017-04-04
• Study First Posted: 2017-04-11
• Primary Completion: 2017-06-01
• Status Verified: 2018-02
• Study Completion: 2018-02-01
• Last Update Submitted: 2018-02-07
• Last Update Posted: 2018-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
repeatability measures	Cardiac assessment repeatability with Kino-cardiograph	In this arm, healthy subjects will undergo repeated measures at different times of the day.
Contractility changes measures	Cardiac contractility assessments with Kino-cardiograph	In this arm, healthy subjects will have their cardiac contractility increased in a controlled way and assessed with both HK and echocardiography.

Primary Outcome Measures

Name	Time	Method
HK reproducibility validation	day 1	Validate the reproducibility of HK measurements in a clinical environment.
Cardiac contractility tracking with HK	day 1	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.

Trial Locations

Locations (1)

Hôpital Erasme; 🇧🇪 Brussels, Anderlecht, Belgium