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3D ECG for Detection of Cardiomyopathy

3D ECG for Detection of Cardiomyopathy in Heart Failure

Sponsors

Hoofdsponsor: University Hospital, Essen

Bron University Hospital, Essen
Korte samenvatting

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.

Algemene status Recruiting
Startdatum 2021-03-14
einddatum 2021-10-14
Primaire voltooiingsdatum 2021-09-14
Studietype Observational
Primaire uitkomst
Meten Tijdsspanne
Cardiomyopathy Within 24 hours
Inschrijving 175
Staat
Interventie

Type interventie: Diagnostic Test

Interventienaam: 3D-ECG

Omschrijving: Patient recieves 3D-ECG Assessement

Armgroeplabel: Patient recieving 3D-ECG-Evaluation

Geschiktheid

Bemonsteringsmethode:

Probability Sample

Criteria:

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

Geslacht:

All

Minimum leeftijd:

18 Years

Maximale leeftijd:

N/A

Gezonde vrijwilligers:

No

Algemeen ambtenaar
Achternaam Rol Verbondenheid
Reza Wakili, Prof. Principal Investigator University Hospital, Essen
Algemeen contact

Achternaam: Reza Wakili, Prof.

Telefoon: 00492017234802

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

Plaats
Faciliteit: Toestand: Contact: Contact backup: West-German Heart and Vascular Center Essen, University Hospital Essen Reza Wakili, Prof. Dr. 0201 723 4802 reza.wakili@uk-essen.de
Locatie Landen

Germany

Verificatiedatum

2021-04-01

Verantwoordelijke partij

Type: Sponsor

Heeft uitgebreide toegang No
Conditie Bladeren
Arm groep

Label: Patient recieving 3D-ECG-Evaluation

Patiëntgegevens No
Bestudeer ontwerpinformatie

Observationeel model: Cohort

Tijdsperspectief: Prospective

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