HealthyMultiKinValNCT03107351
Cardiac Linear and Torsional Contractility Measurements With a New Technology: Multi Dimensional Kineticardiography
A study testing Cardiac contractility assessments with Kino-cardiograph and Cardiac assessment repeatability with Kino-cardiograph in people with Healthy, run by Erasme University Hospital at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Cardiac contractility assessments with Kino-cardiograph and Cardiac assessment repeatability with Kino-cardiograph
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteBelgium
- Study dates
- 27 Mar 2017to 1 Feb 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Healthy
- Being tested
- Cardiac contractility assessments with Kino-cardiograph, Cardiac assessment repeatability with Kino-cardiograph
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac contractility assessments with Kino-cardiographDevice
Cardiac contractility will be assessed with Kino-cardiograph device. Echocardiography will also be used for the experimental arm
Cardiac assessment repeatability with Kino-cardiographDevice
Cardiac contractility will be assessed with Kino-cardiograph device only, at different times of the day to assess the repeatability of the measures.
| Study group | Role | What they receive |
|---|---|---|
| repeatability measures | Sham comparator | In this arm, healthy subjects will undergo repeated measures at different times of the day. Receives: 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. Receives: Device: Cardiac contractility assessments with Kino-cardiograph |
What is being measured
The primary outcome is the main question the study is designed to answer.
HK reproducibility validation
Validate the reproducibility of HK measurements in a clinical environment.
Measured: 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.
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2017
- Study start27 Mar 2017
- Primary completion1 Jun 2017
- Study completion1 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Double blind randomized crossover active vs placebo
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erasme University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Philippe Van de Borne, Erasme University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03107351
- Sponsor's protocol ID
- P2016/474
- Acronym
- MultiKinVal
- Status last verified
- Feb 2018
- First submitted
- 22 Feb 2017
- Last updated
- 9 Feb 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 33407507
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation Study of Cardiac Linear and Torsional Contractility Measurements With a New Technology: Multi Dimensional Kineticardiography (MKCG)
- ClinicalTrials.gov ID
- NCT03107351
- Acronym / sponsor ID
- MultiKinVal / P2016/474
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Erasme University HospitalUniversity, hospital or other
- Study start
- 27 Mar 2017 (actual)
- Primary completion
- 1 Jun 2017 (actual)
- Study completion
- 1 Feb 2018 (actual)
- First posted
- 11 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Double blind randomized crossover active vs placebo
| Arm | Type | Receives |
|---|---|---|
| repeatability measures | Sham comparator | Device: Cardiac assessment repeatability with Kino-cardiographIn this arm, healthy subjects will undergo repeated measures at different times of the day. |
| Contractility changes measures | Experimental | Device: Cardiac contractility assessments with Kino-cardiographIn this arm, healthy subjects will have their cardiac contractility increased in a controlled way and assessed with both HK and echocardiography. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiac contractility assessments with Kino-cardiographCardiac contractility will be assessed with Kino-cardiograph device. Echocardiography will also be used for the experimental arm | Device | Contractility changes measures |
| Cardiac assessment repeatability with Kino-cardiographCardiac contractility will be assessed with Kino-cardiograph device only, at different times of the day to assess the repeatability of the measures. | Device | repeatability measures |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2018.
- Derived from this study: PubMed 33407507Hossein 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.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cardiac contractility assessments with Kino-cardiograph and Cardiac assessment repeatability with Kino-cardiograph in people with Healthy, run by Erasme University Hospital at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HK reproducibility validation (time frame: day 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03107351, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2018.