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EVAluation of the Non Inferiority of Interpretability of Cardiokin Compared to Holter (EVANI)
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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Healthy Volunteers | Device: Cardioskin Device: Holter | Not Applicable |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 39 participants |
| Allocation: | Randomized |
| Intervention Model: | Crossover Assignment |
| Intervention Model Description: | Monocentric, cross study, randomized |
| Masking: | Single (Outcomes Assessor) |
| Primary Purpose: | Other |
| Official Title: | EVAluation of the Non Inferiority of Interpretability of Cardiokin Compared to Holter |
| Actual Study Start Date : | July 8, 2019 |
| Actual Primary Completion Date : | January 1, 2020 |
| Actual Study Completion Date : | January 1, 2020 |
| Arm | Intervention/treatment |
|---|---|
|
Cardioskin-Holter
Subjects in the randomized group A, start by wear the Cardioskin during 24h, and after wear the Holter during 24h.
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Device: Cardioskin
Subjects will have a 24h recording with Cardioskin, next will be unequipped.
Device: Holter Subjects will have a 24h recording with Holter, next will be unequipped.
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Holter-Cardioskin
Subjects in the randomized group B, start by wear the Holter during 24h, and after wear the Cardioskin during 24h.
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Device: Cardioskin
Subjects will have a 24h recording with Cardioskin, next will be unequipped.
Device: Holter Subjects will have a 24h recording with Holter, next will be unequipped.
|
- interpretability of signal [ Time Frame: 48 hours ]The quality signal will be assess blindly by rythm specialists. For that,specialists will show is the isoelectric line is stable (answer "Yes" "No")
- interpretability of signal [ Time Frame: 48 hours ]The quality signal will be assess blindly by rythm specialists. For that,specialists will show the p waves are visible (answer "Yes" "No")
- interpretability of signal [ Time Frame: 48 hours ]The quality signal will be assess blindly by rythm specialists. For that,specialists will show if the R pic are visible (answer "Yes" "No")
- interpretability of signal [ Time Frame: 48 hours ]The quality signal will be assess blindly by rythm specialists. For that,specialists will show is the RR intervals are visible (answer "Yes" "No")
- interpretability of signal [ Time Frame: 48 hours ]Cardiac observations will lead to a unique evaluation of the quality signal: either "interpretable" either "non-interpretable" (answer "Yes" "No")
- interpretability of signal for a fine analysis of cardiac repolarization [ Time Frame: 48 hours ]The quality signal will be assess blindly by rythm specialists. For that, specialists will observe if the QRS width is measurable (answer "Yes" "No")
- interpretability of signal for a fine analysis of cardiac repolarization [ Time Frame: 48 hours ]The quality signal will be assess blindly by rythm specialists. For that, specialists will observe if the T waves are visible (answer "Yes" "No")
- interpretability of signal for a fine analysis of cardiac repolarization [ Time Frame: 48 hours ]The quality signal will be assess blindly by rythm specialists. For that, specialists will observe if the ST segment is analyzable (answer "Yes" "No")
- interpretability of signal for a fine analysis of cardiac repolarization [ Time Frame: 48 hours ]The quality signal will be assess blindly by rythm specialists. For that, specialists will observe if the QT interval is measurable (answer "Yes" "No")
- interpretability of signal for a fine analysis of cardiac repolarization [ Time Frame: 48 hours ]These cardiac observations will lead to a unique evaluation of the quality signal: either "interpretable" either "non-interpretable" (answer "Yes" "No")
- evaluation of comfort [ Time Frame: 24 hours ]At the end of each recording, a subject will answer to a questionnary For comfort of the textile: Score of 0 to 70 points where 0 is comfortable and 70 is not comfortable.
- evaluation of usability [ Time Frame: 24 hours ]
At the end of each recording, a subject will answer to a questionnary
For usability of the system: score of 0 to 100 points where 0 is a bad usability and 100 is excellent
| Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
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
| France | |
| European Hospital George Pompidou | |
| Paris, France, 75015 | |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date ICMJE | April 19, 2019 | ||||
| First Posted Date ICMJE | April 30, 2019 | ||||
| Last Update Posted Date | January 22, 2020 | ||||
| Actual Study Start Date ICMJE | July 8, 2019 | ||||
| Actual Primary Completion Date | January 1, 2020 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | EVAluation of the Non Inferiority of Interpretability of Cardiokin Compared to Holter | ||||
| Official Title ICMJE | EVAluation of the Non Inferiority of Interpretability of Cardiokin Compared to Holter | ||||
| 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. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Not Applicable | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Intervention Model Description: Monocentric, cross study, randomized Masking: Single (Outcomes Assessor)Primary Purpose: Other |
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| Condition ICMJE | Healthy Volunteers | ||||
| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Actual Enrollment ICMJE |
39 | ||||
| Original Estimated Enrollment ICMJE |
36 | ||||
| Actual Study Completion Date ICMJE | January 1, 2020 | ||||
| Actual Primary Completion Date | January 1, 2020 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
Polyamide - Polyester - Elastane - Other synthetic materials - Silicone - Silver
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years to 70 Years (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers ICMJE | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries ICMJE | France | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT03932227 | ||||
| Other Study ID Numbers ICMJE | 2019-A00922-55 | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | BioSerenity | ||||
| Study Sponsor ICMJE | BioSerenity | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE | Not Provided | ||||
| PRS Account | BioSerenity | ||||
| Verification Date | January 2020 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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