Validation of Taxinomisis stratification tool through observational multicentre clinical trial

Carotid artery atherosclerosis is the primary trigger of ischemic
cerebrovascular events including stroke. It causes major morbidity, mortality
and healthcare costs worldwide. Still, treatment is based on criteria
established in the 90s that do not take into account the molecular evolution we
have witnessed since, nor the introduction of new medication, leading to
remarkably high unnecessary surgical treatment while missing patients at risk.

The Taxinomisis clinical trial is part of the Taxinomisis project. The concept
of the Taxinomisis project is to stratify carotid artery disease patients
relying on new modern data corresponding to contemporary patients and adjust
such stratification through a prospective clinical trial. Initial step of the
project is characterization of symptomatic and asymptomatic carotid
atherosclerotic plaque lesions, identification of risk and susceptibility
factors through the exploitation of longitudinal cohort data and multiomics and
disintegration of carotid artery disease phenotypes into endotypes through
joint modeling of multipleomics datasets and systems medicine approaches.
Finally such stratification model will be validated and adjusted in this
Taxinomisis clinical trial.

Aim of the trial is to validate the TAXINOMISIS system for risk stratification
of carotid artery stenotic disease.

European multicentre prospective observational clinical study

The burden and risks for enrolled patients are estimated as small. Study
procedures will be combined with the regular visits at their treating vascular
surgeon. After the regular visit, the researcher will ask additional questions
about medical history regarding cardiovascular diseases, measure the vital
signs and collect a venous blood sample for basic blood tests. An extra blood
sample will be stored in order to perform later analysis of relevant
biomarkers. During the total study duration of three years, this includes four
times (inclusion, 12, 24 and 36 months). Moreover, patients will undergo three
times (at inclusion, 12 and 36 months) an extra MRI-DWI brain for silent brain
lesions combined with MRA of the carotid arteries to determine plaque
evolution. Patients that are treated with CEA or CAS, only one MRI-MRA is
performed at inclusion and not in the follow-up. Patients will also undergo 2
extra MRI scans during follow-up if they receive CAS or CEA provided that they
have a contralateral stenosis (in which an intervention is not performed).
Specifically for CEA patients, the carotid plaque tissue will be collected
during the procedure and stored for later histological- and biochemical
analysis.
The risks associated with this clinical trial are small due to its
observational nature. All study procedures are routinely used for this
indication. MRI is a non-invasive techniques and, in absence of
contraindications, known for no risks. Venipuncture is known for minor risks
that are easily treatable. The benefits are potentially very valuable as this
study will increase our understanding of the pathogenesis and progression of
carotid artery atherosclerosis. This will provide new insights in future
personalized treatment of carotid artery stenosis and rationally influence
morbidity, mortality and health care costs associated with this disease.