Quick test for STROKE risk diagnosis
Problem to be solved
Stroke is responsible for more than 10% of deaths worldwide and represents one of the main causes of disability in developed countries. The identification of high-risk patients would allow designing specific therapeutic options to reduce the occurrence of vascular events in this pathology. Current diagnostic techniques for atherosclerotic disease and stroke prediction are costly, invasive and not sensitive enough before plaque rupture. Thus, there is a need to create a new diagnostic method more sensitive and less invasive to detect the disease.
This circulating biomarker can be used: 1) to detect vulnerable atherothrombotic plaque in patients with high-grade carotid artery stenosis and to predict the risk of primary and secondary ischemic stroke; 2) as a prognostic biomarker to monitor the effectiveness of the best medical treatment and for the occurrence or restenosis; and 3) for long-term management monitoring and/or outcome prediction after carotid revascularization procedures.
It is intended that health services have available a diagnostic system, based on strips of paper and colorimetry, easy to interpret, that can give a quick, cheap response (without the need for expensive imaging techniques, which are not sensitive enough) for the immediate identification and follow-up of individuals at risk, and able to reach all levels of health in the general population. Moreover, a quick diagnostic test based in our circulating miRNA, in addition to acting as a diagnostic tool, can be a key element in facilitating the decision-making of health professionals.
ICirculating miRNA validated in pilot studies using human serum samples with successfully outcome. A portion of these results is about to be published (Luque et al. (2018) J. Neurosurg, In Press). IP status: A European patent application has been filed (EP16382025.1) and the PCT submission has been requested PCT/EP2017/051316
Carotid artery atherosclerosis has become one of the major high risk mechanism for the occurrence of ischemic stroke, which represents more than 80% of all cerebrovascular events. In clinical practice, the degree of carotid artery stenosis and plaque neovascularization evaluated through imaging techniques such as contrast-enhanced ultrasound, positron emission tomography/computed tomography (PET/TC), and magnetic resonance is being considered a most important predictor of carotid plaque vulnerability and, consequently, of increased risk of stroke in patients with carotid artery disease. Nevertheless, a major limitation of the present imaging techniques is their application only in advanced stages of atherosclerotic disease. Thus, novel diagnostic markers using minimally invasive approaches are needed for a more specific and sensitive prediction of atherosclerosis load and progression, and particularly, to reliably identify patients with high-risk carotid plaques for early and accurate stroke risk stratification.
Our biomarker, a serum miRNA with diagnostic and prognostic potential, has been associated for the first time with atherosclerotic disease of the carotid artery. Therefore, this novel and independent biomarker for vulnerable atherothrombotic plaque identification will facilitate primary and secondary ischemic stroke risk prediction, and may assist monitoring the effectiveness of medical treatment in these patients. Thus, developing the Ischemic Stroke Risk-TEST (ISR-TEST) we aim to obtain a diagnostic tool for the prediction and monitoring the risk of ischemic stroke based on the combination of two novel concepts: 1) the use of circulating miRNAs as biomarkers, and 2) the technology of μPADs (microfluidics paper-based analytical device) based on the design of microfluidic devices in paper support, developed by the collaborating spin-off Paperdrop Dx. The paper-based device is characterized by its low cost, ease of use and portability, all without sacrificing the sensitivity and specificity obtained in laboratory tests. Our development platform facilitates, adapt and deploy the accurate analysis of said circulating miRNA biomarker in one-step test through a single drop of blood.
Aran JM (IDIBELL)
Technology Readiness Level
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