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

February 7, 2018 updated by: Philippe Van de Borne, Erasme University Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
    • Anderlecht
      • Brussels, Anderlecht, Belgium, 1070
        • Hopital Erasme

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Device Feasibility
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: repeatability measures
In this arm, healthy subjects will undergo repeated measures at different times of the day.
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.
Experimental: 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.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HK reproducibility validation
Time Frame: day 1
Validate the reproducibility of HK measurements in a clinical environment.
day 1
Cardiac contractility tracking with HK
Time Frame: 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.
day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Erasme University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 27, 2017

Primary Completion (Actual)

June 1, 2017

Study Completion (Actual)

February 1, 2018

Study Registration Dates

First Submitted

February 22, 2017

First Submitted That Met QC Criteria

April 4, 2017

First Posted (Actual)

April 11, 2017

Study Record Updates

Last Update Posted (Actual)

February 9, 2018

Last Update Submitted That Met QC Criteria

February 7, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • P2016/474

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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