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Eur. J. Clin. Invest. · Dec 2020
Observational StudyThe TAXINOMISIS Project. A multidisciplinary approach for the development of a new risk stratification model for patients with asymptomatic carotid artery stenosis.
- Nathalie Timmerman, George Galyfos, Fragiska Sigala, Kalliopi Thanopoulou, Gert J de Borst, Lazar Davidovic, Hans-Henning Eckstein, Nenad Filipovic, Roberto Grugni, Michael Kallmayer, de KleijnDominique P VDPVDepartment of Vascular Surgery, Division of Surgical Specialties, University Medical Centre Utrecht, Utrecht University, Utrecht, the Netherlands., Igor Koncar, Michalis D Mantzaris, Elisabeth Marchal, Miltiadis Matsagkas, Perica Mutavdzic, Domenico Palombo, Gerard Pasterkamp, Vassiliki T Potsika, Evangelos Andreakos, Dimitrios I Fotiadis, and all partners of the TAXINOMISIS Consortium.
- Department of Vascular Surgery, Division of Surgical Specialties, University Medical Centre Utrecht, Utrecht University, Utrecht, the Netherlands.
- Eur. J. Clin. Invest. 2020 Dec 1; 50 (12): e13411.
IntroductionAsymptomatic 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 Current risk stratification for patients with ACAS is largely based on outdated randomized-controlled trials that lack the integration of improved medical therapies and risk factor control.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 AnalysisThe 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.ConclusionResults from the TAXINOMISIS study could potentially improve future risk stratification in patients with ACAS to assist personalized evidence-based treatment decision-making.© 2020 The Authors. European Journal of Clinical Investigation published by John Wiley & Sons Ltd on behalf of Stichting European Society for Clinical Investigation Journal Foundation.
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