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

Overview

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Device Feasibility
    • Masking: Double (Participant, Outcomes Assessor)
  • Study Primary Completion Date: June 1, 2017

Interventions

  • 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
  • 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.

Arms, Groups and Cohorts

  • Sham Comparator: repeatability measures
    • In this arm, healthy subjects will undergo repeated measures at different times of the day.
  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • HK reproducibility validation
    • Time Frame: day 1
    • Validate the reproducibility of HK measurements in a clinical environment.
  • 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.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 50 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Erasme University Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Philippe Van de Borne, Professor – Erasme University Hospital

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