Clinical trial NCT03932227: EVAluation of the Non Inferiority of Interpretability of Cardiokin Compared to Holter
Official title: EVAluation of the Non Inferiority of Interpretability of Cardiokin Compared to Holter
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Volunteers
Lead sponsor: BioSerenity
Sponsor class: INDUSTRY
First posted: 2019-04-30
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Monocentric, cross study, randomized
Primary purpose: OTHER

Brief summary: The aim is to evaluate the electrocardiogram quality signal of the Cardioskin device and compare it with a Holter signal. For that, volunteers subjects will wear the Cardioskin and Holter, non-simultaneously, for about 24 hours.

This study is open, and will be carried out according to a cross plan. The trial will include approximately 36-40 subjects between 18 and 70 years old.

Detailed description: The wear of the first device will be randomized. Each subject will wear the two devices.

One group will start with a 24-hour environmental recording with Cardioskin and then will perform another recording of about 24 hours with the Holter. Conversely, group B will start with the Holter and then will continue with Cardioskin. It is a randomization software that will assign a group to each included participant.

Each participant will come three times at hospital : one for inclusion and equipment of the first device, another to be unequipped and equipped of the second device. They will come another time to bring back the material. The total time of participation is of two days and half.

The first aim is to evaluate if the signal interpretability is non-inferior to an Holter, for a recording of 24h (classic analysis of rhythm).

The second aim is to evaluate if the 24 hours signal interpretability is non-inferior to an Holter in the case of a repolarization analysis.

The third aim is to compare the comfort and usability between Cardioskin and Holter.

Eligibility criteria: Inclusion Criteria:

* people between 18 and 70 years old

Exclusion Criteria:

* Minors
* Pregnant, parturient or breastfeeding women
* Refusal of consent
* Participant with known cardiac history
* Participant with cardiac arrhythmia observed during control ECG
* Participant who may be exposed to ionizing or electromagnetic radiation on days when devices (Cardioskin, Holter) will be worn
* Allergy to one of the components of the Cardioskin T-shirt, including:

Polyamide - Polyester - Elastane - Other synthetic materials - Silicone - Silver

* Allergy to one of the components of the electrodes used for the Holter (Kendall 530 or similar)
* Sensory disturbances that make the participant unresponsive to pain
* Motor or mental disorders that prevent the participant from expressing their pain -Behavioral problems that make the participant excessively Agitated or Aggressive
* Cardiorespiratory disorders that may be aggravated by mild compression of the chest
* Weight and / or size not suitable for the proposed Cardioskin T-shirt designs
* Open wound on the skin in the area covered by Cardioskin textile or by the electrodes of the Holter
* Irritation, and / or erythema in the area covered by the Cardioskin textile or by the electrodes of the Holter
* Pregnancy clinically detectable or known to a participant
* Participant with a high infectious risk
* Person wearing breast prostheses
* Simultaneous participation in another search

Primary outcomes:
measure: interpretability of signal
timeFrame: 48 hours
measure: interpretability of signal
timeFrame: 48 hours
measure: interpretability of signal
timeFrame: 48 hours
measure: interpretability of signal
timeFrame: 48 hours
measure: interpretability of signal
timeFrame: 48 hours
Secondary outcomes:
measure: interpretability of signal for a fine analysis of cardiac repolarization
timeFrame: 48 hours
measure: interpretability of signal for a fine analysis of cardiac repolarization
timeFrame: 48 hours
measure: interpretability of signal for a fine analysis of cardiac repolarization
timeFrame: 48 hours
measure: interpretability of signal for a fine analysis of cardiac repolarization
timeFrame: 48 hours
measure: interpretability of signal for a fine analysis of cardiac repolarization
timeFrame: 48 hours
measure: evaluation of comfort
timeFrame: 24 hours
measure: evaluation of usability
timeFrame: 24 hours
Other outcomes:
Locations:
city: Paris
country: France
facility: European Hospital George Pompidou
Study officials:
References: