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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

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
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
Misurare Lasso di tempo
Cardiomyopathy Within 24 hours
Iscrizione 175
Condizione
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
Cognome Ruolo Affiliazione
Reza Wakili, Prof. Principal Investigator University Hospital, Essen
Contatto generale

Cognome: Reza Wakili, Prof.

Telefono: 00492017234802

E-mail: reza.wakili@uk-essen.de

Posizione
Servizio, struttura: Stato: Contatto: Contatta il backup: West-German Heart and Vascular Center Essen, University Hospital Essen Reza Wakili, Prof. Dr. 0201 723 4802 reza.wakili@uk-essen.de
Paesi di posizione

Germany

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.

analytics

Prove cliniche su Heart Failure

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