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Scientific Evidence and Clinical Observations

The advantage of Cardisiography lies in the early detection of heart disease in people who are still completely asymptomatic.

Studies show results that demonstrate the clear benefits of the method for early detection of reduced blood flow to the heart muscle.

A comprehensive summary of the scientific background and our study results can be found here:

Study Results

Overview

Cardisio Peer Reviewed Study

Frankfurt, January 16, 2020: In the current issue, the renowned journal “Journal of Electrocardiology” publishes a peer-reviewed study demonstrating the impressive precision of Cardisiography in screening coronary heart disease. The article provides results on the sensitivity and specificity of Cardisiography: The sensitivity is 97% for male subjects, 90% for females, i.e. 97% of sick men are recognized as diseased and 90% of women. In terms of specificity, the women who participated in the study are ahead of the men with 74% with 76%, i.e. 76% of healthy women are recognized as healthy and 74% of men. Cardisiography is the first procedure that can be used to determine the risk of coronary heart disease (CHD) in asymptomatic people non-invasively, quickly and cheaply.

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Cardisio Validation Study Sana Heart Center Cottbus

Frankfurt, March 10, 2020: For the second time within a short period of time, a clinical study has come to the conclusion that Cardisiography achieves comparable results in the detection of coronary heart disease (CHD) as the current gold standard, coronary angiography.

The team led by Dr. Temirlan Erkenov from the Department of Cardiac Surgery at SANA Heart Center in Cottbus, Germany, concluded that: “… Cardisiography is a simple, precise and highly valid method that is suitable as a non-invasive diagnostic modality for the initial assessment of stable CHD in a clinical setting…” (Cardisiography as a novel non-invasive diagnostic tool for the detection of coronary artery disease at rest – a first prospective study of diagnostic accuracy; Temirlan Erkenov, Tomasz Stankowski, Oliver Grimmig, Sören Just, Prof. Oleg Remizov, Prof. Dirk Fritsche)

The study included data from 106 patients in whom coronary angiography was indicated and performed. Subsequently, Cardisiography was performed, the result of which was blindly correlated with that of coronary angiography. The result: In a total of 86 of the 106 patients, vascular disease was confirmed by coronary angiography. Cardisiography identified 82 of the 86 cases (95.4 percent), while conventional echocardiography detected only 12 cases. This results in a sensitivity of 95.4 percent for Cardisiography, a specificity of 90 percent and a positive predictive value of 97.6 percent for CHD.

“In Western countries, coronary heart disease is one of the leading causes of death and a common cause of physical disability. The reason for the severe course is the fact that the initial manifestation of the disease can be a heart attack or sudden cardiac death. Cardisiography is a new, easy-to-use and examiner-independent technology that uses vector cardiography with the modern analysis possibilities of artificial intelligence,” the authors explain the reason for conducting the study – and for its convincing course.

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Study Heart Center Bad Oeynhausen: Germany Comparison of Cardisiography (CSG) with myocardial SPECT in suspected CHD and known CHD

Study at the Heart and Diabetes Center North Rhine-Westphalia in Bad Oeynhausen confirms the diagnostic relevance of Cardisiography.

Comparison of Cardisiography (CSG) with myocardial SPECT in suspected and known CHD:

  • Cardisiography (CSG) shows a significant correlation with MPS in pre-diagnostic testing for CHD
  • A normal CSG correlates with a normal to low pathologic MPS, corresponding to a high negative predictive value of 98%
  • CSG is suitable as a pre-selection tool for GP or cardiology practices to decide on non-invasive imaging in patients with suspected CHD

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Congress of the European Society of Cardiology 2023 – HDZ-NRW / Mediacc: Comparison of cardisiography with CVRF score for non-invasive assessment of CHD

Summary and interpretation:

The CSG index (CSG parameter) was compared with the CVRF score in terms of predictive power for the presence of CHD

  • Modified PROCAM score (CVRF score)
    • Classic risk score for determining the pre-test probability of coronary heart disease
  • Current analysis:
    • 407 patients
      • 225 patients HDZ, Bad Oeynhausen
      • 182 patients from a GP practice, Berlin

Results

“The CSG Index differentiated those with no signs and symptoms of CHD and patients with CHD and is a better predictor for cardiovascular risk than the classical risk factors”

  • The CSG is superior to the CVRF score for the non-invasive assessment of CHD
  • CSG index correlates significantly (p < 0.001) with clinically confirmed CHD status
  • NPV (negative predictive value) of the CSG was 91%

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German Society for Cardiology - Cardiovascular Research e.V. Heart Days 2023 – Sensitivity and Specificity of the Artificial Intelligence-Based 5-Lead 3D Vectorcardiography in Patients With Suspected or Confirmed Coronary Heart Disease

Originally presented at the DGK Herztage 2023. Published in the American Heart Association Circulation. 2023;148:A15181

Purpose of the study  

  • Validate Artificial Intelligence-based 5-lead 3D-vectorcardiography (5L3DVCG-AI) 
  • Use additional information of 5L3DVCG-AI over standard 12-lead electrocardiography (ECG) in the detection of coronary vascular disease (CVD) at rest  
  • Basis for investigation of 5L3DVCG-AI as a new screening tool for CVD in ongoing prospective multinational trials 

Conclusion
These data extend the previous findings of 5L3DVCG-AI identifying CVD patients with cardiac ischaemia from those without to now differentiating healthy controls from CVD and those with higher risk for CVD. 5L3DVCG-AI may thus be a further scalable screening method to identify patients at risk for CVD in need for risk modification or further diagnostic procedures.
5L3DVCG-AI-derived ECG showed high correlation and low bias compared to standard 12-lead ECG. The ongoing prospective large-scale performance clinical trials will have to confirm these preliminary data to verify the diagnostic accuracy. 

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German Society for Cardiology - Cardiovascular Research e.V. Heart Days 2023 – 5-lead 3D-vectorcardiography differentiates between high and low cardiovascular risk profiles in patients with suspected or known coronary heart disease

Purpose of the study 

  • Validate Artificial Intelligence-based 5-lead 3D-vectorcardiography (5L3DVCG-AI)  
  • use additional information of 5L3DVCG-AI over standard 12-lead electrocardiography (ECG) in the detection of coronary vascular disease (CVD) at rest  
  • basis for investigation of 5L3DVCG-AI as a new screening tool for CVD in ongoing prospective multinational trials 

Conclusion

  • Data extend the previous findings of 5L3DVCG-AI identifying CVD patients with cardiac ischaemia 
  • Now differentiating healthy controls from CVD and those with higher risk for CVD 
  • Confirmation of results in female population 
  • Validation of ECG-reconstruction via heart axis 
  • CSG-Index is superior to CVRF-Score in identification of CVD  
  • The ongoing prospective large-scale performance clinical trials will have to confirm these preliminary data to verify the diagnostic accuracy. 

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American Heart Association Scientific Sessions 2023 – Validation of the Artificial Intelligence Based 5 Lead 3D Vectorcardiography in Comparison to the 12 Lead ECG in a Mixed Population

Originally presented at the AHA 23 (American Heart Association Scientific Sessions 2023) and published in the American Heart Association Circulation. 2023;148:A16473.

Purpose of the study  

  • Validate Artificial Intelligence based 5 lead 3D vectorcardiography (5 L 3 DVCG AI)  
  • Use additional information of 5 L 3 DVCG AI over standard 12 lead electrocardiography (ECG) in the detection of cardiac pathology at rest.  
  • Basis for investigation of 5 L 3 DVCG AI as a new screening tool for cardiac pathology in ongoing prospective multinational trials

Conclusion 

  • 5 L 3 DVCG AI derived ECG showed high correlation and low bias compared to standard 12 lead ECG 
  • Easy to use 5 lead ECG may replace 12 lead ECG without major training or expertise  
  • Shorter intervals to be considered when interpreting 5 L 12 L ECG and “normal” values in the ongoing prospective large scale performance clinical trials  
  • 5 L 3 DVCG AI identifies persons at risk for CVD (s abstract 15181 PSu 3119) 

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German Society for Cardiology - Cardiovascular Research e.V - 90. DGK-Jahrestagung 2024 – 5L3DVCG-AI for identification of cardiac pathology in a mixed population

Originally presented at the 90. DGK-Jahrestagung 2024.

Purpose of the study

  • Artificial Intelligence (AI) and access to a large global clinical data repository have the potential to boost the performance of Vectorcardiography (VCG) beyond conventional techniques.
  • Quantifying cardiovascular risk (CVR) according to SCORE2, QRISK3 or ASCVD is not always feasible, especially in hard to reach populations.
  • The modified PROCAM-Score (CVRF-Score) is a validated alternative.

Conclusion

  • AI further improves the easy-to-use and inexpensive 5L3DVCG
  • 5L3DVCG-AI identifies asymptomatic females at high risk for CVD
  • CSG-Index differentiated between no signs and symptoms of CVD and patients with cardiac pathology or CVD
  • 5L3DVCG-AI identifies patients at risk for CVD and cardiac pathology
  • 5L3DVCG-AI opens up a diagnostic window for early detection of CVD
  • CSG is superior to CVRF-Score in differentiating people at risk of CVD or cardiopathology, especially for women and hard-to-reach population

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National Health Service (NHS) - SBRI - Assessing the impact of using community-based heart testing to detect early signs of cardiovascular disease through a novel, quick, low-cost test which uses sophisticated AI-based analysis.

Study completed. Results will be available soon…

Complementary Studies And Literature On Our Technology

The Poynting Vector: Power and Energy in Electromagnetic Fields

Carpenter KH. The Poynting vector: power and energy in electromagnetic fields. Department of Electrical and Computer Engineering. Kansas State University (2004)

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Spatial Vector Electrocardiography; The Clinical Characteristics of S-T and T Vectors

Grant RP, Estes EH Jr, Doyle JT. Spatial vector electrocardiography; the clinical characteristics of S-T and T vectors. Circulation. 1951 Feb;3(2):182-97.

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Cardiogoniometry: A New Noninvasive Method for Detection of Ischemic Heart Disease

Saner H, Baur HR, Sanz E, Gurtner HP. Cardiogoniometry: a new noninvasive method for detection of ischemic heart disease. Clin Cardiol. 1983 May;6(5):207-10.

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Cardiogoniometry: An Electrocardiographic, Non-Invasive and Stress-Free Method for Detecting Cardiac Ischemia

Sanz, Ee. Schüpbach, M. Cardiogoniometry: an electrocardiographic, non-invasive and stress-free method for the detection of cardiac ischemia. GMS Medical Informatics, Biometry and Epidemiology. 5 (2009).

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Applicability of Cardiogoniometry as a Non-Invasive Screening Tool for the Detection of Graft Vasculopathy in Heart Transplant Recipients

Spiliopoulos S, Hergesell V, Fischer D, Dapunt O, Krueger U, Koerfer R, Tenderich G. Applicability of cardiogoniometry as a non-invasive screening tool for the detection of graft vasculopathy in heart transplant recipients. Interact Cardiovasc Thorac Surg. 2016 Dec;23(6):976-978.

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Computer Analysis of the Corrected, Orthogonal Cardiogram

von Mengden, H.J., Brodda, K. Computer analysis of the corrected, orthogonal cardiogram. Archiv für Kreislaufforschung 67, 123–141 (1972).

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Assessment of the Spatial QRS-T Angle by Vectorcardiography: Current Data and Perspectives

Voulgari C, Tentolouris N. Assessment of the Spatial QRS-T Angle by Vectorcardiography: Current Data and Perspectives. Curr Cardiol Rev. 2009 Nov;5(4):251-62. doi: 10.2174/157340309789317850. Erratum in: Curr Cardiol Rev. 2010 Nov;6(4):373.

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Improved Evaluation of Left Ventricular Hypertrophy Using the Spatial QRS-T Angle by Electrocardiography

Maanja, M., Schlegel, T.T., Kozor, R. et al. Improved evaluation of left ventricular hypertrophy using the spatial QRS-T angle by electrocardiography. Sci Rep 12, 15106 (2022).

Link