Analysis of optical signals to improve the screening of cardiac arrhythmias
Zusammenfassung der Studie
The objective is to develop a computer program that allows for a presumptive diagnosis of the type of arrhythmia the patient suffers from. Such a means is currently lacking. Indeed, although smartwatches offer the possibility of cardiac monitoring (using a photoplethysmography signal, PPG), no presumptive diagnosis can currently be established. If the study is successful, the results would allow for better prediction of the type of arrhythmia for a given patient, thus limiting the need to consult specialists and/or possibly reducing the need for sometimes complex additional examinations.
(BASEC)
Untersuchte Intervention
Recording the electrical signals of the heart by measuring a photoplethysmography (PPG) signal during an investigation or treatment of cardiac rhythm disorders.
(BASEC)
Untersuchte Krankheit(en)
Cardiac rhythm disorders
(BASEC)
- Age: >18 years - At least one of the following cardiac arrhythmias: sustained or nonsustained ventricular tachycardia, sustained or nonsustained atrial tachycardia, atrial flutter, frequent atrial and/or ventricular ectopic beats, atrial and/or ventricular bigeminy, left bundle branch block, second or third degree atrioventricular block, reentrant atrioventricular tachycardia or reentrant nodal atrioventricular tachycardia, atrial fibrillation - Signed consent (BASEC)
Ausschlusskriterien
- Patient refusal to participate in the study - Patient unable to discern or under guardianship - Patient already included in another study (ClinO/HRO) that could affect the objectives of this study (BASEC)
Studienstandort
Lausanne
(BASEC)
Sponsor
CHUV
(BASEC)
Kontakt für weitere Auskünfte zur Studie
Kontaktperson Schweiz
Prof. Etienne Pruvot
+41 21 314 00 12
etienne.pruvot@clutterchuv.chCHUV
(BASEC)
Allgemeine Auskünfte
Centre Hospitalier Universitaire Vaudois
(ICTRP)
Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)
Ethikkommission Waadt
(BASEC)
Datum der Bewilligung durch die Ethikkommission
25.05.2021
(BASEC)
ICTRP Studien-ID
NCT04884100 (ICTRP)
Offizieller Titel (Genehmigt von der Ethikkommission)
EnHeart : exploring full content of optical signals to enhance cardiac arrhythmia screening (BASEC)
Wissenschaftlicher Titel
enHEART - Exploring Full Content of Optical Signals to Enhance Cardiac Arrhythmia Screening (ICTRP)
Öffentlicher Titel
enHEART - Exploring Full Content of Optical Signals to Enhance Cardiac Arrhythmia Screening (ICTRP)
Untersuchte Krankheit(en)
Premature Atrial Complex
Premature Ventricular Contraction
Atrial Flutter
Nodal Tachycardia
Arrhythmias, Cardiac
Atrial Fibrillation
Atrioventricular Block
Atrioventricular Tachycardia
Ventricular Tachycardia
(ICTRP)
Untersuchte Intervention
Other: Validating and improving PPG-based algorithms
(ICTRP)
Studientyp
Interventional (ICTRP)
Studiendesign
Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Diagnostic. Masking: None (Open Label). (ICTRP)
Ein-/Ausschlusskriterien
Inclusion Criteria:
1. Age = 18-year-old,
2. Able to speak/read/understand French,
3. Informed consent signed, and
4. at least one of the following cardiac arrhythmias:
- sustained or non-sustained ventricular tachycardia,
- sustained or non-sustained atrial tachycardia
- atrial flutter,
- frequent atrial and/or ventricular ectopic beats,
- ventricular and/or atrial bigeminy,
- left bundle branch block,
- second- or third-degree atrioventricular block,
- atrioventricular reentrant tachycardia or atrioventricular node reentrant
tachycardia,
- AF
Exclusion Criteria:
1. Patient is pregnant or breastfeeding,
2. Refusal of participation by the patient
3. Patient is less than 18 years old,
4. Patient incapable of judgement or under tutelage, or
5. Patient is already included in another human research project (ClinO/HRO) that may
affect the objectives of this study.
(ICTRP)
nicht verfügbar
Primäre und sekundäre Endpunkte
Performances of cardiac arrhythmias classification based on Photoplethysmography (PPG) signals.
(ICTRP)
nicht verfügbar
Registrierungsdatum
07.05.2021 (ICTRP)
Einschluss des ersten Teilnehmers
15.09.2021 (ICTRP)
Sekundäre Sponsoren
nicht verfügbar
Weitere Kontakte
Etienne PRUVOT, Professor, Centre Hospitalier Universitaire Vaudois (ICTRP)
Sekundäre IDs
2021-00586 (ICTRP)
Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten
nicht verfügbar
Weitere Informationen zur Studie
https://trialsearch.who.int/Trial2.aspx?TrialID=NCT04884100 (ICTRP)
Ergebnisse der Studie
Zusammenfassung der Ergebnisse
nicht verfügbar
Link zu den Ergebnissen im Primärregister
nicht verfügbar