3D ECG for Detection of Cardiomyopathy

Heart Failure Clinical Trial

Official title:

3D ECG for Detection of Cardiomyopathy in Heart Failure

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04830696
• Other study ID #: 20-9268-BO-2
• Status: Recruiting
• Start date: March 14, 2021
• Est. completion date: October 14, 2021

Study information

• Verified date: April 2021
• Source: University Hospital, Essen
• Contact: Reza Wakili, Prof.
• Phone: 00492017234802
• Email: reza.wakili[@]uk-essen.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 175
• Est. completion date: October 14, 2021
• Est. primary completion date: September 14, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age >18 Years

• Established diagnosis heart failure and suggested cardiomyopathy

Exclusion Criteria:

• Patients unable to sign informed consent

• Pacemaker-stimulated ECG

Related Conditions & MeSH terms

• Amyloidosis
• Arrhythmia
• ARVD
• Cardiac Amyloidosis
• Cardiac Hypertrophy
• Cardiomegaly
• Cardiomyopathies
• Cardiomyopathy, Hypertrophic
• Cardiovascular Diseases
• Heart Diseases
• Heart Failure
• Hypertensive Heart Disease
• Hypertrophic Cardiomyopathy
• Hypertrophy
• Ischemic Cardiomyopathy
• Restrictive Cardiomyopathy

Intervention

Diagnostic Test:
• 3D-ECG
Patient recieves 3D-ECG Assessement

Locations

Country	Name	City	State
Germany	West-German Heart and Vascular Center Essen, University Hospital Essen	Essen	NRW

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Essen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiomyopathy	Diagnosis of Cardiomyopathy	Within 24 hours