3D ECG for Detection of Cardiomyopathy

3D ECG for Detection of Cardiomyopathy in Heart Failure

Sponsors

Lead Sponsor: University Hospital, Essen

Source University Hospital, Essen
Brief 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.
Overall Status Recruiting
Start Date 2021-03-14
Completion Date 2021-10-14
Primary Completion Date 2021-09-14
Study Type Observational
Primary Outcome
Measure Time Frame
Cardiomyopathy Within 24 hours
Enrollment 175
Condition
Intervention

Intervention Type: Diagnostic Test

Intervention Name: 3D-ECG

Description: Patient recieves 3D-ECG Assessement

Arm Group Label: Patient recieving 3D-ECG-Evaluation

Eligibility

Sampling Method:

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

Gender:

All

Minimum Age:

18 Years

Maximum Age:

N/A

Healthy Volunteers:

No
Overall Official
Last Name Role Affiliation
Reza Wakili, Prof. Principal Investigator University Hospital, Essen
Overall Contact

Last Name: Reza Wakili, Prof.

Phone: 00492017234802

Email: reza.wakili@uk-essen.de

Location
Facility: Status: 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
Location Countries

Germany
Verification Date

2021-04-01
Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Arm Group

Label: Patient recieving 3D-ECG-Evaluation

Patient Data No
Study Design Info

Observational Model: Cohort

Time Perspective: 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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