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

NCT03107351 | Completed

• 1 other identifier: P2016/474
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• HK reproducibility validation

  Validate the reproducibility of HK measurements in a clinical environment.

  day 1

• 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

Study Arms (2)

repeatability measures

SHAM COMPARATOR

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

Device: Cardiac assessment repeatability with Kino-cardiograph

Contractility changes measures

EXPERIMENTAL

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

Interventions

Cardiac contractility assessments with Kino-cardiograph DEVICE

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

Contractility changes measures

Cardiac assessment repeatability with Kino-cardiograph DEVICE

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

repeatability measures

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Erasme University Hospital: lead

Study Sites (1)

Hôpital Erasme

Brussels, Anderlecht, 1070, Belgium

Location

Related Publications (1)

• Hossein A, Rabineau J, Gorlier D, Pinki F, van de Borne P, Nonclercq A, Migeotte PF. Effects of acquisition device, sampling rate, and record length on kinocardiography during position-induced haemodynamic changes. Biomed Eng Online. 2021 Jan 6;20(1):3. doi: 10.1186/s12938-020-00837-5.

  PMID: 33407507 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: DEVICE FEASIBILITY
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Double blind randomized crossover active vs placebo

Study Record Dates

• First Submitted: February 22, 2017
• First Posted: April 11, 2017
• Study Start: March 27, 2017
• Primary Completion: June 1, 2017
• Study Completion: February 1, 2018
• Last Updated: February 9, 2018

Record last verified: 2018-02

Locations

BE (1)