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| ID | Type | Description | Link |
|---|---|---|---|
| 156/2022/Disp/AOUBo | Other Identifier | Comitato Etico di Area Vasta Emilia Centro della Regione Emilia-Romagna (CE-AVEC) |
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| Name | Class |
|---|---|
| AccYouRate S.p.A. | UNKNOWN |
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Evaluation of an innovative smart t-shirt capable to monitor ECG signal and related parameters through the comparison with a Holter ECG and a smartwatch
The primary purpose of this study is to evaluate the biosignal (ECG) acquisition features of the smart t-shirt, developed by University of Bologna in collaboration with AccYouRate S.p.A., comparing it with a standard Holter ECG. Secondly, the study wants to compare the parameters related to ECG signal calculated by the smart t-shirt with those calculated by commercial smartwatches.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Smart t-shirt, ECG Holter and smartwatch patients | 24h ECG Monitoring - All participants will wear the smart t-shirt, the ECG Holter and the smartwatch at the same time |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Smart t-shirt | Device | 24h ECG Monitoring with the smart t-shirt under study |
|
| Measure | Description | Time Frame |
|---|---|---|
| Electrocardiogram (ECG): Heart rate (beats per minute) | Smart t-shirt and ECG Holter comparison | 24 hours |
| Electrocardiogram (ECG): RR interval (seconds) | Smart t-shirt and ECG Holter comparison | 24 hours |
| Electrocardiogram (ECG): Qualitative distinction of P-waves, QRS-complexes, T-waves, and noise levels | Smart t-shirt and ECG Holter comparison | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Electrocardiogram (ECG): Heart rate (beats per minute) | Smart t-shirt and smartwatch comparison | 24 hours |
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Inclusion Criteria:
Exclusion Criteria:
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The study will be conducted in subjects with heart rhythm pathologies or under assessment of possible heart rhythm pathologies.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Luca Neri | Contact | +14432538858 | luca.neri9@unibo.it | |
| Claudio Borghi | Contact | claudio.borghi@unibo.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Policlinico Sant'Orsola Malpighi - University of Bologna | Recruiting | Bologna | 40138 | Italy |
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| ECG Holter | Device | 24h ECG Monitoring with ECG Holter |
|
| Smartwatch | Device | 24h ECG Monitoring with a smartwatch |
|
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D015716 | Electrocardiography, Ambulatory |
| ID | Term |
|---|---|
| D004562 | Electrocardiography |
| D006334 | Heart Function Tests |
| D003935 | Diagnostic Techniques, Cardiovascular |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D004568 | Electrodiagnosis |
| D018670 | Monitoring, Ambulatory |
| D008991 | Monitoring, Physiologic |
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