FREQUENTLY ASKED QUESTIONS

Clinical FAQs

Cardisiography (CSG) Detects

The Cardisiograph designed to detect early signs of Heart Disease. Using vectorcardiography together with artificial intelligence our technology detects:
 

Rhytmological Diseases

Cardiac arrhythmias (rhythmology) are noticed by patients as an abnormally beating heart. Physicians can distinguish between the slow heartbeat (bradycardia), the misguided heartbeat (bundle branch block) and the fast heartbeat (tachycardia).

 

Coronary Diseases

In coronary heart disease (CHD), the coronary arteries are narrowed and calcified as a result of atherosclerosis. Atherosclerosis refers to the pathological storage of cholesterol esters and other fats in the inner wall layer of arterial blood vessels. This inflammatory process can begin at a young age.

 

Structural Diseases 

“Structural heart disease” refers to all diseases of the heart involving a physical defect in the valves or the walls of the heart, affecting it’s functioning.

No.  It’s significantly more advanced than an ECG, and uses a far higher proportion of the data captured than and ECG. (Over 95% for the Cardisiograph vs. c25% for the ECG). The analysis carried out on the data is also far more sophisticated and uses both machine learning artificial intelligence and a large data set to constantly improve the accuracy of the results.

Both the design and the pricing of the test are designed to be accessible to large groups, and in particular the asymptomatic and undiagnosed CHD sufferers.

As long as it is Network connected.  The Cardisiograhy needs to be connected to a network via a PC, in order for the data to be analysed in the Cardisio Cloud

The Cardisiograph is approved as a Class 1 medical device in the EU.

Data Security and Protection Toolkit – https://www.dsptoolkit.nhs.uk/OrganisationSearch/L6D3A

MHRA – UKCA 

https://pard.mhra.gov.uk/manufacturer-search/cardisio

 

 

Yes, Cardisio stores anonymised information relating to each test. They do not store your name, but may store relating information such as your Patient Reference Number, which could be tied back to your name.

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.

Download Journal

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.

Download abstract

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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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%

View Abstract

End user FAQs

The Cardisio heart test is revolutionary in its ability to detect heart disease at its earliest stages, especially coronary artery disease (CAD), long before symptoms become evident. Traditional methods often identify heart conditions only once significant damage has already occurred. By utilising advanced vectorcardiography (VCG) and artificial intelligence technology, Cardisio offers you the chance to protect your heart health proactively.

Why is this important?
Currently, heart health testing is not routinely offered in the UK, and there is no national heart disease screening program in place. This makes the Cardisio test a unique and accessible option for anyone over the age of 18 who wants to assess their heart health and take preventive action.

Take charge of your health now.
Early detection of heart disease can dramatically reduce your risk of severe complications and improve your long-term health outcomes. The Cardisio test is non-invasive, fast and accurate, offering peace of mind without the need for hospital visits.

  • Anyone who just wants to be certain their heart is in tip-top condition.
  • Anyone who is about to start exercising or join a gym or plan a 5K run or a marathon.
  • Those who have a family history of heart disease.
  • Those who smoke or are overweight.
  • Anyone with diabetes, high blood pressure or cholesterol issues.
  • If you experience symptoms such as shortness of breath, fatigue or chest discomfort.

First and foremost, don’t worry.
1. What does a “Visible indications of a possible disorder” result mean?
• Potential signs of heart disease: Visible indications of a possible disorder suggest potential signs of heart disease or dysfunction. This does not confirm a diagnosis but indicates the need for further investigation.
• Test sensitivity: The Cardisio test is very sensitive and can detect very small differences in the electrical activity within your heart. This result indicates visible signs of a possible heart disorder that require further evaluation by a doctor.
• Please do not worry: This result should only be seen as needing urgent follow-up, if you also experience any of the symptoms listed at the end of this section.
• This is not a formal diagnosis: This result does not confirm heart disease but suggests potential risk factors or areas that could benefit from further evaluation.
2. Important recommendations:
• Consult your doctor: Schedule a follow-up appointment with your GP to discuss your results in detail. If you have indicated on the consent form that you are happy for the results to be sent to your GP, the pharmacist will do this.
• Additional tests: Your doctor may recommend additional diagnostic tests, such as blood tests for cardiac markers, or refer you to hospital to see a cardiologist.
3. Managing symptoms:
• If you experience any symptoms listed at the end of this leaflet, please call 111 or if urgent 999.
4. Lifestyle adjustments: While awaiting to see your doctor, adopt these heart-healthy habits:
• Reduce salt, sugar, and unhealthy fats in your diet.
• Avoid any strenuous physical activity.
• Avoid alcohol and tobacco completely, and limit caffeine intake.
5. Emotional well-being: It’s normal to have concerns about these types of results. Take time to discuss them with your doctor.
Your health is our priority. With timely care and the right interventions, many heart conditions can be well-managed. Please reach out with any questions or for further guidance.
(Physical symptoms to be aware of, if you experience any of these please call 111 or if urgent 999)
Classic symptoms of heart disorders, including heart attack, may include chest pain or discomfort, pain radiating to the arms, neck, or jaw, shortness of breath, nausea, or cold sweats. Circulatory disorders like stroke can present with sudden weakness or numbness on one side of the body, difficulty speaking or understanding, dizziness, or a severe headache. Being aware of these symptoms can help ensure timely medical attention.

There are two issues to understand here.  Having close blood relatives who have been diagnosed with coronary heart diseases is regarded as a risk factor for you, but it isn’t proof.  The other issue you should understand is that coronary heart disease doesn’t necessarily have noticeable symptoms.  That’s what makes the Cardisiograph so ground-breaking – for the first time it’s possible to detect issues in people with no symptoms in a cost effective, low risk and non-invasive way.

In a word, science! The Cardisiograph uses electrodes to capture electrical information from your heart and this is used to build a 3D ‘model’ of your heart’s behaviour.  Using artificial intelligence, this is compared to a ‘healthy’ heart and any anomalies highlighted.
A major difference with other methods that capture electrical signals from your heart (such as the ECG) is the use the Cardisio approach makes of the data captured.  The ECG makes use of roughly 15% of data captured and discards the rest, whereas the Cardisiograph analyses more than 95% of the data.  More data leads to more detailed information, and better outcomes.

Please refer to this guidance

Link

The data is transmitted securely to Cardisio in Germany.  Once received, the data is processed using the Cardisio proprietary software using artificial intelligence.  The individual report is ‘rendered’ and sent back to the requester. The results are then stored anonymously to aid future research and continuous improvement of the Algorithms.