Solutions

THE ONLY DIAGNOSTIC TEST FOR CORONARY HEART DISEASE THAT IS HIGHLY ACCURATE AND NON INVASIVE

The Cardisio heart screening test (Cardisiography) is a highly-accurate test to diagnose coronary heart disease with a sensitivity of 98% and a specificity of 85%. It is a non-invasive, examiner independent, reproducible, fast and cost-effective diagnostic procedure for the detection of hemodynamic relevant stenoses of the coronary arteries at rest.

Because of its reliability and easy application, the Cardisio screening test offers a complementary screening to legacy methods including electrocardiogram (ECG), stress ECG and echocardiography. The Cardisiogram helps identify a risk for CHD and to determine further diagnostic steps.

Compared with the golden standard of coronary diagnostics the coronary angiography with a specificity and sensitivity of 100%, non-invasive procedures such as the resting ECG and resting Echocardiography show a significantly lower sensitivity and specificity. Only under exercise, these increase for both methods but require the attendance of a physician, further more in case of stress echocardiography, the results are examiner dependent and both procedures are time consuming (15-30 min). Other non-invasive procedures like Myocardial Perfusion Scintigraphy (MPS), Coronary Computer Tomography (CCT) or Cardiac Magnetic Resonance Imaging (MRI) require a considerable equipment and personnel expenditure, the presence of a Physician and also represent a significant cost factor.

CARDISIOGRAPH’S SCIENTIFIC APPROACH

Cardisiography is based on a 3-dimensional scan of the heart. It relies on automated analysis, eliminating room for human error in diagnosing. The diagnosis is done via a computer-based infinitesimal, three-dimensional Calculation of the excitation processes of the mammalian heart based on a specific algorithm in conjunction with a neural network correlated to the intrinsic blood as well as the specific spatial orientation of the myocardium in the di-pole field as a function of time starting from a defined point.

The Cardisiography delivers graphic representations of the electro-physical characteristics of the heart. Cardisio utilizes machine-based learning to continuously optimize its own algorithm.

In its development, the Cardisio screening test was correlated with matching representative cohorts, including over 500 patients with clinical indication for a coronary angiogram.

Fig 1: Healthy Cardisiogram

Fig 2: Pathologic Cardisiogram

The initial Cardisiography clinical study is based on a sample of 182 patients who had been admitted for a coronary angiogram at various heart centres in Germany. Data collection was conducted from April until September 2017 and included 89 male patients, age range 39-84 and 93 female, age range 28-88. The researchers performed a on each patient a Cardisiography and compared the results to the angiogram.

The male sample demonstrated a sensitivity of 97.3%, with a negative predictive value of 99%, and a specificity of 62.5%, with a positive predictive value of 22.4%. The female sample generated a sensitivity of 86%, with a negative predictive value of 97%, and a specificity of 75%, with positive predictive value of 26.5%. A prevalence of 10% was assumed for both genders, meaning that roughly 10% of the overall population suffer from coronary heart disease. By definition, patients undergoing a coronary angiogram test positive at a much higher rate than the general population. Statistical computations were used to correct for the difference in distribution of positive test results, which resulted in a Negative Predictive Value (NPV) of 99% for both genders.

Fig 3: Left: Results for the entire male group including training, validation and test data; Right: Results exclusively for test data.

HOW CARDISIO WORKS

The Cardisio test is a user-friendly screening test for coronary heart disease. Administering the test requires minimal training and is being conducted on a resting heart. The system consists of three components, the Cardisio Graph to physically administer the test, the Cardisio App to start, end and present the results of the Cardisiogra-phy, and the Cardisio Cloud, where a proprietary, self-training algorithm conducts the analysis and produces the diagnoses.

Step 1.

The heart is in a resting state.
Test person applies electrodes to chest
Electrodes are connected to the Cardisiograph.
Cardisiograph connects via a USB cable to a PC

Step 2.

The clinician initiates the test using the Cardisio Application on a PC.
The test takes four minutes to complete.

Step 3.

After 4 minutes the data collection will complete and the Cardisio Application will tell the Clinician to wait while the data is securely transmitted to the Cardisio Cloud.
The Cardisio Cloud is a proprietary algorithm, using machine learning artificial intelligence which analyses the data.
Once analysed the results are transmitted back to the clinician.

Step 4.

Depending on the test result, the app displays either a green light or a red light.
A green light indicates with virtual certainty that the test person does not have coronary heart disease.
A red light indicates that the person should consult with a physician about further screening for coronary heart disease.
A PDF with the full results is sent to the Clinician for presentation to the patient

INSIGHTS

The Cardisio App guides you through the screening test in 5 steps. The whole process takes between 6 to 8 minutes.

In step 5 the screening result including a clear index will be shown.

Interpretation Guidelines, Parameters and Examples are included in the documentation.

Fig 5: Start the process – enter the patient BMI data

Fig 6:Cardisiography results presentation.

ABOUT CARDISIO

Cardisio GmbH, established in Frankfurt/Germany in 2016, is a privately held health company. Cardisio’s US headquarters are in San Francisco, California

Scientific Advisory Board:

Prof.Dr.med. Dr. h.c. Reiner Körfer (Germany)
Prof.Dr.med. Gero Tenderich (Germany)
Michael M.Koerner, MD, PhD Adjunct Clinical Professor (USA)
Wilfried Jacobs (Germany)

Cardisio is a registered trademark of Cardisio GmbH in the United States.