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

Healthy Clinical Trial

— MultiKinVal  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03107351
• Other study ID #: P2016/474
• Status: Completed
• Phase: N/A
• First received: February 22, 2017
• Last updated: February 7, 2018
• Start date: March 27, 2017
• Est. completion date: February 1, 2018

Study information

• Verified date: February 2018
• Source: Erasme University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: February 1, 2018
• Est. primary completion date: June 1, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

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

Locations

Country	Name	City	State
Belgium	Hôpital Erasme	Brussels	Anderlecht

Sponsors (1)

Lead Sponsor	Collaborator
Erasme University Hospital

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HK reproducibility validation	Validate the reproducibility of HK measurements in a clinical environment.	day 1
Primary	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