FREQUENTLY ASKED QUESTIONS

Clinical FAQs

The Cardisiograph is designed for early detection of heart disease, including:

  • Rhythmological Diseases: Identifies cardiac arrhythmias, such as bradycardia (slow heartbeat), bundle branch block (misguided heartbeat), and tachycardia (fast heartbeat).

  • Coronary Diseases: Detects coronary heart disease (CHD), a condition where the coronary arteries narrow due to atherosclerosis—a buildup of cholesterol and fats causing arterial inflammation.

  • Structural Diseases: Identifies defects in heart valves or walls that impact heart function.

No, the Cardisiograph offers far more than a standard ECG by:

  • Capturing 95%+ of the heart’s electrical activity, compared to approximately 25% in traditional ECGs.

  • Using AI-powered vectorcardiography (VCG), which continuously improves accuracy through machine learning.

  • Offering a faster, more detailed, and predictive analysis of heart health.

Yes. The Cardisiograph is designed for high-volume screening, making it an ideal solution for workplaces, community health programs, and asymptomatic individuals at risk of undiagnosed coronary heart disease (CHD).


 

Yes, as long as the Cardisiograph device is network-connected via a wi-fi or ethernet connection, allowing for secure data analysis through the Cardisio Cloud.

The Cardisiograph has been approved in multiple territories, including:

  • European Union: Recognized as a Class I medical device.

  • United Kingdom: Approved by the Medicines and Healthcare products Regulatory Agency (MHRA) and UKCA marked.

  • Data Security Compliance: Meets Data Security and Protection Toolkit (DSPT) standards.


 

 

Yes, The patient consents to allowing the Cardisio Cloud to securely store the following data:

First Name, Family Name, Age, Height, Weight, BMI, Some previous medical history.

The name information is required for data matching and patient safety when communicating results.

Several studies confirm the effectiveness of Cardisiography as a reliable diagnostic tool:

  • Peer-Reviewed Study (Journal of Electrocardiology):

    • Sensitivity: 97% (males), 90% (females)

    • Specificity: 74% (males), 76% (females)

  • NHS SBRI Healthcare Assessment: Evaluated the role of community-based heart testing in primary care using Cardisiography’s AI-powered diagnostics.

  • Sana Heart Center Cottbus Validation Study: Concluded that Cardisiography is a precise, non-invasive, and highly effective diagnostic tool, comparable to coronary angiography in detecting CHD.


 

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

Download Overview

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

Heart disease is the leading cause of death in the UK, with conditions like coronary artery disease (CAD) often showing no symptoms until it’s too late. This risk isn’t limited to older adults; it can affect anyone, regardless of age or gender. According to the British Heart Foundation and NHS England, cardiovascular disease (CVD) remains one of the leading health challenges in the UK.

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

  • 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.

Yes, even if you have no symptoms, a family history of heart disease increases your risk of developing cardiovascular conditions. Many heart conditions, including coronary artery disease (CAD), progress silently before noticeable symptoms appear.

Early Detection Can Prevent Future Problems – Heart disease often develops over time. Identifying risk early allows for preventative action, potentially avoiding severe complications. ✔ Genetics Play a Major Role – If close relatives have heart disease, your risk is higher, even if you maintain a healthy lifestyle. ✔ Symptoms Can Be Subtle or Absent – Some individuals with significant heart disease experience no warning signs. The Cardisio test provides insights into your heart health even before symptoms develop. ✔ Non-Invasive, Fast, and Accessible – The test is quick, pain-free, and available at select community pharmacies for easy and convenient heart health screening.

Taking a proactive approach to heart health can provide peace of mind and allow for early intervention if needed. The Cardisio Heart Test helps identify potential concerns before they become critical.


 

 

The Cardisio Heart Test provides a more accessible and proactive approach to heart health screening, particularly for community pharmacies offering health checks to the general public. Unlike traditional primary care heart checks, which often focus on detecting risk factors (such as blood pressure and cholesterol levels), the Cardisio Heart Test identifies actual heart abnormalities at an early stage.

Advanced Detection Using Vectorcardiography (VCG) and AI Analysis – Unlike standard ECGs, which capture limited heart electrical activity, Cardisio provides a full 3D analysis for precise coronary artery disease (CAD) detection. ✔ Ideal for Preventative Screening in Community Pharmacies – Many GP-led heart checks focus on existing conditions. The Cardisio test allows pharmacies to offer a proactive heart health service, identifying potential issues before symptoms develop. ✔ Quick, Non-Invasive, and Immediate Results – Unlike tests requiring blood samples or hospital visits, Cardisio is pain-free, takes just 4 minutes, and provides instant results. ✔ Improves Accessibility for the Public – Many people find it difficult to access timely cardiac assessments through their GP. By offering the Cardisio Heart Test in pharmacies, communities gain easier access to preventative heart screening.

By incorporating Cardisio into community pharmacy services, individuals benefit from a convenient, fast, and accurate tool for detecting heart disease early, helping to reduce the burden on primary care while improving patient outcomes.

 

The General Pharmaceutical Council’s (GPhC) “In practice: Guidance on consent” (June 2018) outlines the responsibilities of pharmacy professionals in obtaining valid consent to ensure person-centred care. Consent is defined as a person’s agreement for a healthcare professional to provide care, treatment, or disclose information. It can be explicit (clearly expressed) or implied (inferred from actions), and must be given voluntarily by an individual with the capacity to decide.assets.pharmacyregulation.org+2assets.pharmacyregulation.org+2assets.pharmacyregulation.org+2

Key Points:

  • Capacity Assessment: Pharmacy professionals must assess whether individuals can understand, retain, and weigh information to make informed decisions. If a person lacks capacity, professionals should act in their best interests, considering legal frameworks and consulting with relevant parties.assets.pharmacyregulation.org

  • Adults with Capacity: Competent adults have the right to accept or refuse treatment. Professionals must respect these decisions, even if they disagree, ensuring the individual is informed about the consequences.

  • Children and Young People: Consent considerations vary based on age and maturity. Young people (16-17 years) are generally presumed to have capacity, while children under 16 must demonstrate sufficient understanding to make decisions. Parental involvement is advised, especially when the young person lacks capacity.

  • Advance Decisions and Emergencies: Professionals should respect valid advance decisions made by individuals regarding future treatment preferences. In emergencies, immediate care may proceed without consent if it’s in the person’s best interests.assets.pharmacyregulation.org

Pharmacy professionals are encouraged to use their judgment, seek advice when uncertain, and ensure all team members understand their responsibilities concerning consent. This guidance aligns with the GPhC’s standards, emphasizing the importance of obtaining consent to provide care and pharmacy services.

For comprehensive details, refer to the full guidance document:

 

In the UK the data collected is transmitted over a secure link to the data centre located in the UK. It is the process by advanced Artificial Intellegence based algorythms. The results are then sent back to the test administrator for printing and communication with the patient. The results are also stored on servers in the secure UK Data Centre.