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3D ECG for Detection of Cardiomyopathy

3D ECG for Detection of Cardiomyopathy in Heart Failure

Sponsorzy

Główny sponsor: University Hospital, Essen

Źródło University Hospital, Essen
Krótkie podsumowanie

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.

Ogólny stan Recruiting
Data rozpoczęcia 2021-03-14
Data zakończenia 2021-10-14
Podstawowa data ukończenia 2021-09-14
Typ studiów Observational
Wynik podstawowy
Pomiar Ramy czasowe
Cardiomyopathy Within 24 hours
Rekrutacja 175
Stan: schorzenie
Interwencja

Rodzaj interwencji: Diagnostic Test

Nazwa interwencji: 3D-ECG

Opis: Patient recieves 3D-ECG Assessement

Etykieta grupy ramion: Patient recieving 3D-ECG-Evaluation

Kwalifikowalność

Metoda próbkowania:

Probability Sample

Kryteria:

Inclusion Criteria: - Age >18 Years - Established diagnosis heart failure and suggested cardiomyopathy Exclusion Criteria: - Patients unable to sign informed consent - Pacemaker-stimulated ECG

Płeć:

All

Minimalny wiek:

18 Years

Maksymalny wiek:

N/A

Zdrowi wolontariusze:

No

Ogólnie urzędnik
Nazwisko Rola Przynależność
Reza Wakili, Prof. Principal Investigator University Hospital, Essen
Ogólny kontakt

Nazwisko: Reza Wakili, Prof.

Telefon: 00492017234802

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

Lokalizacja
Obiekt: Status: Kontakt: Kopia zapasowa kontaktów: West-German Heart and Vascular Center Essen, University Hospital Essen Reza Wakili, Prof. Dr. 0201 723 4802 reza.wakili@uk-essen.de
Kraje lokalizacji

Germany

Data weryfikacji

2021-04-01

Odpowiedzialna impreza

Rodzaj: Sponsor

Ma rozszerzony dostęp No
Przeglądanie warunków
Grupa Arm

Etykieta: Patient recieving 3D-ECG-Evaluation

Dane pacjenta No
Badanie informacji o projekcie

Model obserwacyjny: Cohort

Perspektywa czasowa: 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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Badania kliniczne na Heart Failure

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