Novel ultrasound-based method to predict strokes caused by atherosclerosis

Purpose and goal:

Ischemic stroke is often caused by the rupture of an atherosclerotic plaque in the carotid artery. Identification and treatment of patients with plaques prone to rupture is therefore an important clinical challenge today. We have recently developed a non-invasive ultrasound method (UPSA) that can assess atherosclerotic plaque composition.

Our objective is to develop a "CE-marked" real-time UPSA ultrasound machine, use it for an impartial assessment in an international hospital and collect clinical in vivo data for a prospective study. Expected results and effects:

The healthcare sector is looking for a method to identify plaque composition (not just size) that is noninvasive, rapid, portable, inexpensive, and does not require contrast media or radiation. Our real-time UPSA ultrasound method meets these criteria and will be used for 1) risk stratification in healthcare, 2) screening to find individuals at risk of developing cardiovascular disease, as well as, 3) monitor interventions and to identify individuals who are suitable for inclusion in clinical trials for various interventions.

Approach and implementation:

In collaboration between Region Skåne, Lund University, and LU Innovation in Lund, we have initiated a strategy to ensure the commercialisation and global use of our novel method. To build a scanner enabling real-time UPSA ultrasound imaging, we will establish a programming structure meeting quality management systems standards suitable for CE-marking and implement our algorithm on an OEM scanner, in consultation with experts.

Subsequently, we will conduct several in vivo studies, including one at an impartial international site.