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The TAXINOMISIS Project: A multidisciplinary approach for the development of a new risk stratification model for patients with asymptomatic carotid artery stenosis
Author(s) -
Timmerman Nathalie,
Galyfos George,
Sigala Fragiska,
Thanopoulou Kalliopi,
de Borst Gert J.,
Davidovic Lazar,
Eckstein HansHenning,
Filipovic Nenad,
Grugni Roberto,
Kallmayer Michael,
de Kleijn Dominique P. V.,
Koncar Igor,
Mantzaris Michalis D.,
Marchal Elisabeth,
Matsagkas Miltiadis,
Mutavdzic Perica,
Palombo Domenico,
Pasterkamp Gerard,
Potsika Vassiliki T.,
Andreakos Evangelos,
Fotiadis Dimitrios I.
Publication year - 2020
Publication title -
european journal of clinical investigation
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.164
H-Index - 107
eISSN - 1365-2362
pISSN - 0014-2972
DOI - 10.1111/eci.13411
Subject(s) - medicine , asymptomatic , stroke (engine) , stenosis , observational study , risk stratification , carotid endarterectomy , clinical endpoint , clinical trial , randomized controlled trial , revascularization , prospective cohort study , intensive care medicine , cardiology , radiology , myocardial infarction , mechanical engineering , engineering
Abstract Introduction Asymptomatic carotid artery stenosis (ACAS) may cause future stroke and therefore patients with ACAS require best medical treatment. Patients at high risk for stroke may opt for additional revascularization (either surgery or stenting) but the future stroke risk should outweigh the risk for peri/post‐operative stroke/death. Current risk stratification for patients with ACAS is largely based on outdated randomized‐controlled trials that lack the integration of improved medical therapies and risk factor control. Furthermore, recent circulating and imaging biomarkers for stroke have never been included in a risk stratification model. The TAXINOMISIS Project aims to develop a new risk stratification model for cerebrovascular complications in patients with ACAS and this will be tested through a prospective observational multicentre clinical trial performed in six major European vascular surgery centres. Methods and analysis The risk stratification model will compromise clinical, circulating, plaque and imaging biomarkers. The prospective multicentre observational study will include 300 patients with 50%‐99% ACAS. The primary endpoint is the three‐year incidence of cerebrovascular complications. Biomarkers will be retrieved from plasma samples, brain MRI, carotid MRA and duplex ultrasound. The TAXINOMISIS Project will serve as a platform for the development of new computer tools that assess plaque progression based on radiology images and a lab‐on‐chip with genetic variants that could predict medication response in individual patients. Conclusion Results from the TAXINOMISIS study could potentially improve future risk stratification in patients with ACAS to assist personalized evidence‐based treatment decision‐making.