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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03107351
Acronym
MultiKinVal
Enrollment
34
Registered
2017-04-11
Start date
2017-03-27
Completion date
2018-02-01
Last updated
2018-02-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

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.

Interventions

DEVICECardiac contractility assessments with Kino-cardiograph

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

DEVICECardiac 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.

Sponsors

Erasme University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DEVICE_FEASIBILITY
Masking
DOUBLE (Subject, Outcomes Assessor)

Intervention model description

Double blind randomized crossover active vs placebo

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
HK reproducibility validationday 1Validate the reproducibility of HK measurements in a clinical environment.
Cardiac contractility tracking with HKday 1Proof that the HK technology can track physiological cardiac changes while comparing with gold standard echocardiography and inducing a cardiac contractility change with dobutamine infusion.

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026