Cardisio demonstrates unprecedented accuracy in new non-invasive coronary artery disease detection
January 14, 2020
FRANKFURT, Germany, Jan. 13, 2020 /PRNewswire/ -- The Journal of Electrocardiology has published a study showing unparalleled accuracy in non-invasive coronary artery disease (CAD) detection using Cardisio's new low-cost method which involves no radiation exposure.
The study demonstrates a sensitivity of over 97% in male patients and over 90% in female patients, and specificity of over 74% and over 76%, respectively.
Cardisiography is a new, unique testing method developed by the European startup Cardisio that delivers highly precise results within just a few minutes. It is a non-invasive, independent, repeatable, fast, and cost-effective method of detecting CAD in the resting heart. It offers a complementary and more effective alternative to traditional procedures such as stress ECG and echocardiography for early identification of heart disease without radiation exposure.
People with coronary artery disease are frequently symptom-free until the onset of a severe event such as a heart attack. Because the Cardisiography test is highly accurate, low-cost and easy to administer, it has the potential to detect CAD earlier, helping patients receive the right pharmacological or other treatment before a potentially fatal heart attack.
"We see great potential in Cardisiography for early detection of symptom-free people with coronary artery disease. Broad-scale early detection has not been possible until now," said Sotirios Spiliopoulos, M.D. Ph.D., Department of Geriatrics, St. Vinzenz-Hospital, Dinslaken, one of the authors of the study.
Cardisio's system consists of two integrated components: the CardisioGraph, a device that records three-dimensional electric currents via five electrodes attached to the thorax, and the CardisioCloud, an Artificial Intelligence (AI) software application that uses multiple algorithms and machine learning methods to evaluate the measurements. The CardisioGraph collects data from the resting heart for approximately four minutes, and the Cardisiography result, along with a supplementary standard ECG report, are available about one minute later.
In the published study, researchers examined 595 patients who had been admitted to several medical centers in Germany for a coronary angiogram, the current gold standard CAD examination. Cardisiography results were compared to results yielded by the angiogram tests.
Following completion of the study referenced above, Cardisio has made improvements to its algorithms that have increased the specificity significantly, along with a slight increase in sensitivity in both males and females.
Cardisio's test system is currently being evaluated in ten further studies at various European medical centers. One of these studies, conducted at the SANA Heart Center in Cottbus, Germany, included 106 patients. The results, showing sensitivity of 95.3% and specificity of 90.3%, will be presented at the International Congress of the European Society of Cardiovascular and Endovascular Surgery in Padua, Italy, in May 2020.
Cardisio is CE-Marked and has begun selling the test system to general practitioners, cardiologists and hospitals in several European countries via resellers and distributors. Cardisio is currently evaluating partners and studies to support regulatory clearance and deployment in the United States and other countries.
"Cardisio embodies a new generation of medical diagnostic systems that are mobile and Internet-based, leveraging new Artificial Intelligence capabilities," said Meik Baumeister, co-founder and CEO of Cardisio. "The combination of classic cardiology coupled with intelligent high-performance algorithms offers us unprecedented opportunities to change how CAD is managed globally."
Headquartered in Frankfurt, Germany, with offices in Berlin and San Francisco, Cardisio is a privately-held mobile health tech company that develops non-invasive, highly accurate tests for detecting coronary artery disease. Called Cardisiography, the test is CE-Marked and commercially available in several European countries.