HEMOFLOW cloud platform for non-invasive hemodynamic diagnositics

The research project ‘HEMOFLOW cloud platform for non-invasive hemodynamic diagnostics’, No. POIR.01.01.01-00-0393/19, aims to assess the diagnostic value of a cloud platform intended for comprehensive, non-invasive anatomico-functional diagnostics of coronary artery disease to improve prognosis.

The HEMOFLOW project is implemented in two phases:

1. a medical research experiment and
2. a clinical investigation of a medical device.

HEMOFLOW is a prospective, multicentre investigation being conducted at reference cardiology research centers in Poland.

The planned number of patients to be enrolled in the study is 150, including 65 participants in the medical research experiment and 85 participants in the clinical investigation. Recruitment is planned to take approximately 19 months.

Enrollees are adult patients with a positive history of Chronic Coronary Syndrome (CCS) who have signed an informed consent to participate in the study and meet all of the following criteria:

• Diagnostic coronary computed tomography angiography (CCTA) reveals at least one ≥50% stenosis of an artery with a diameter >2.0 mm which has not been previously revascularized.
• Invasive coronary angiography (ICA) with FFR assessment performed ≤4 months of the CCTA in at least one 50-90% stenosed epicardial artery of >0 mm in diameter which has not been previously revascularized.
• Standard treatment of chronic coronary syndrome not requiring dose modification for at least 4 weeks prior to enrolment.

The diagnostic technology tested in the study is based on computer modeling with Computational Fluid Dynamics (CFD). The diagnostic system will be available as a cloud-based service, operating on the Software as a Service model. The new diagnostic platform will enable physicians to perform a stand-alone structural and functional assessment based on a virtual three-dimensional reconstruction of the patient’s coronary arteries (virtual measurement of fractional coronary flow reserve – FFR) correlated with a three-dimensional visualization of the myocardium (virtual three-dimensional perfusion maps).

Once its efficacy has been confirmed in clinical trials, this solution will be a globally unique tool for the diagnostics of ischaemic heart disease.

The use of new solutions that combine the non-invasive anatomical evaluation of the coronary arteries with a functional CT-based assessment of any existing stenoses and resulting myocardial perfusion abnormalities will significantly increase diagnostic accuracy and enable earlier identification of patients requiring invasive treatment. In addition, it provides an opportunity to increase the proportion of invasive coronary interventions (PCI) performed within arteries with adequately documented myocardial ischemia, which will consequently improve prognosis in this group of patients.