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3D ECG for Detection of Cardiomyopathy
3D ECG for Detection of Cardiomyopathy in Heart Failure
Sponsor |
Lead Sponsor: University Hospital, Essen |
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Fonte | University Hospital, Essen |
Breve riassunto | There is existing data in the literature that suggests an additional predictive value of three dimensional ECG with respect to the presence of electrical abnormalities and for an existing cardiac disease. Especially regarding patients who suffered from a myocardial infarction in the past (post MI patients), evidence has been provided for a potential association of 3D repolarisation abnormalities and incidence of sudden cardiac death (SCD). In addition, there is some vague evidence of so called 3D ECG and prediction of coronary artery disease. This 3D ECG device is using the technology of 3D ECG vector loops and is assessing the variability of these ECG vector loops in the 3-dimensional space. Based on these data, the parameters of 3D ECG are suggested to carry certain value to predict or to identify individuals already suffering from a cardiac disease or being at risk experiencing a cardiac event in the future. In this context we performed a preliminary study with 3D-ECG device in healthy volunteers evaluating the robustness of this method with respect to reproducibility, intra- and intra-observer variability which could be confirmed. We thus postulate that the 3D ECG technology might bear the potential to serve as a sufficient screening method for diagnosing cardiomyopathy in patients with an unknown heart failure etiology. |
Stato generale | Recruiting | ||||
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Data d'inizio | 2021-03-14 | ||||
Data di completamento | 2021-10-14 | ||||
Data di completamento principale | 2021-09-14 | ||||
Tipo di studio | Observational | ||||
Il risultato principale |
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Iscrizione | 175 |
Condizione | |
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Intervento |
Tipo di intervento: Diagnostic Test Nome intervento: 3D-ECG Descrizione: Patient recieves 3D-ECG Assessement Etichetta del gruppo del braccio: Patient recieving 3D-ECG-Evaluation |
Eleggibilità |
Metodo di campionamento: Probability Sample
Criteri:
Inclusion Criteria: - Age >18 Years - Established diagnosis heart failure and suggested cardiomyopathy Exclusion Criteria: - Patients unable to sign informed consent - Pacemaker-stimulated ECG Genere: All Età minima: 18 Years Età massima: N/A Volontari sani: No |
Ufficiale generale |
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Contatto generale |
Cognome: Reza Wakili, Prof. Telefono: 00492017234802 E-mail: reza.wakili@uk-essen.de |
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Posizione |
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Paesi di posizione |
Germany |
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Data di verifica |
2021-04-01 |
Parte responsabile |
Genere: Sponsor |
Ha accesso esteso | No |
Condizione Sfoglia | |
Braccio di gruppo |
Etichetta: Patient recieving 3D-ECG-Evaluation |
Dati del paziente | No |
Informazioni sul design dello studio |
Modello osservazionale: Cohort Prospettiva temporale: Prospective |
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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