Development of an innovative diagnostic process for early detection of cardiovascular diseases.

Project Objective

The R&D objective of this project was to develop an innovative and technologically advanced diagnostic process to improve the early detection and risk assessment of cardiovascular diseases, specifically focusing on coronary artery health and potential future heart attacks.

Current traditional approaches tend to identify and therefore address cardiovascular disease when disease has been established already and focus on controlling rather than preventing the disease. The project aim was to address the limitations of existing standard diagnostic solutions and provide a more comprehensive and accurate assessment of patients’ cardiovascular health, ultimately leading to more effective clinical interventions and improved patient outcomes.

Scientific Baseline

The baseline upon which the advance is being measured is the ability of existing conventional approaches to diagnose and assess early signs of cardiovascular diseases. Typically, these involve the use of conventional screening methods such as CT1 coronary calcium scanning and stress ECG2 testing. While these methods have been widely used and have provided valuable insights, they have significant limitations in accurately predicting and detecting early-stage coronary artery disease.

CT coronary calcium scanning, despite offering reduced radiation exposure and not requiring contrast dye injection, primarily focuses on detecting coronary artery calcification and may not effectively capture coronary artery blood flow impairment and narrowing. Stress ECG testing, on the other hand, is limited in its ability to detect subtle abnormalities in individuals without significant cardiovascular disease. Thus, these standard solutions fell short in providing a comprehensive evaluation of patients’ cardiovascular health, often leading to missed diagnoses and delayed interventions.

Scientific Advancement Achieved

The company’s research and development team undertook the development of an innovative diagnostic process that employed enhanced image analysis technology. This advancement involved the creation of a coronary fat attention and inflammation index, coupled with coronary plaque burden assessments, to comprehensively stratify patient risk for future cardiac events. The technology allowed for precise quantification of coronary inflammation (FAI-Score3) and the absolute risk of a fatal cardiac event within the next 8 years, taking into account the personalised FAI-Score values and clinical risk factors. By capturing both the presence of atherogenic particle<sup>4</sup> using Apolipoprotein (apo) B markers and evaluating the omega 6/3 ratio, the tool significantly improved risk assessment accuracy, providing a more robust basis for clinical interventions and disease prevention strategies in cardiovascular medicine.

The company’s research and development team has integrated these various tests and imaging techniques to create an innovative diagnostic process for cardiovascular risk assessment and disease prevention in their new technology. This combined diagnostic protocol offers a more thorough and precise evaluation of patient risk for future cardiac events. By implementing enhanced image analysis technology alongside the assessment of coronary inflammation, plaque burden, Apolipoprotein (apo) B markers, and Omega 6/3 ratio, the designed process significantly improves risk assessment accuracy. The addition of functional testing with VO2 max testing also allows for a better assessment of cardiorespiratory fitness and future life expectancy prediction.

1CT is a calcium score test is a CT (computed tomography) scan that looks at how much calcium is in the coronary arteries. Elevated calcium scores are directly linked to heart attack risk.
2Stress ECG: an exercise ECG, also called an exercise tolerance test, is an electrocardiogram (ECG) that is recorded while cycling on an exercise bike. The aim of the test is to see how the heart adapts to exercise stressors.
3Measurement of the perivascular fat attenuation index (FAI) may help identify coronary inflammation and direct further diagnostic testing to identify CAD.
4Atherogenic particles refer to particles in the bloodstream that contribute to the development of atherosclerosis, a condition in which fatty deposits (plaque) accumulate and narrow the arteries, increasing the risk of cardiovascular diseases.

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