3D ECG for Detection of Cardiomyopathy

Last updated: April 2, 2021
Sponsor: University Hospital, Essen
Overall Status: Active - Recruiting

Phase

N/A

Condition

Heart Failure

Arrhythmia

Amyloidosis

Treatment

N/A

Clinical Study ID

NCT04830696
20-9268-BO-2
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age >18 Years
  • Established diagnosis heart failure and suggested cardiomyopathy

Exclusion

Exclusion Criteria:

  • Patients unable to sign informed consent
  • Pacemaker-stimulated ECG

Study Design

Total Participants: 175
Study Start date:
March 14, 2021
Estimated Completion Date:
October 14, 2021

Connect with a study center

  • West-German Heart and Vascular Center Essen, University Hospital Essen

    Essen, NRW 45147
    Germany

    Active - Recruiting

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