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Trial record 23 of 48 for:    Recruiting, Not yet recruiting, Available Studies | "Carotid Stenosis"

Stratification of Patient With Carotid Disease (TAXINOMISIS)

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ClinicalTrials.gov Identifier: NCT03495830
Recruitment Status : Recruiting
First Posted : April 12, 2018
Last Update Posted : July 23, 2018
Sponsor:
Collaborators:
Ludwig-Maximilians - University of Munich
University of Barcelona
University of Athens
University of Genova
Utrecht University
Information provided by (Responsible Party):
Igor Koncar, University of Belgrade

Brief Summary:
Introduction: Taxinomisis trial is part of the Taxinomisis project. The concept of the Taxinomisis project is to stratify carotid artery disease relying on new modern data corresponding to contemporary patients based on information from longitudinal studies. Taxinomisis trial will validate this tool and adjust such stratification. 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 data sets and systems medicine approaches. Finally such stratification model will be validated and adjusted in the Taxinomisis clinical trial.

Condition or disease Intervention/treatment
Carotid Artery Stenosis Procedure: Carotid endarterectomy

Detailed Description:

Aim of the trial is to validate TAXINOMISIS system for risk stratification of carotid artery stenotic disease. Primary endpoints are stroke, transitory ischemic attack or retinal symptom while secondary endpoints are MRI silent brain lesions and carotid plaque progression.

Patient with moderate to severe extra-cranial, both asymptomatic and symptomatic, carotid artery stenosis will be enrolled in the prospective observational multi-center trial in five European (Athens, Barcelona, Belgrade, Genoa, Munich and Utrecht) vascular centers. Inclusion will last from 31.3.2018 - 01.06.2019. Patients with short life expectancy, high potential of stroke from other cause or patients with complex and tandem carotid lesions will be excluded from the trial.

Included patients will be examined clinically, basic laboratory exam will be performed and part of blood specimen will be stored and assessed later. Carotid plaque will be analysed by means of duplex and MRI image while brain lesions will be detected on brain MRI.

Treatment strategy will be dependent on guidelines of good clinical practice and let independently to institutional multidisciplinary panelist board. In patients treated with carotid endarterectomy (CEA) carotid plaque will be stored and assessed for future analysis. In respect to allocated therapy patients will follow different follow up protocols.

Intervention group: Patients undergoing intervention CEA or carotid artery stenting (CAS), will be followed by clinical examination and carotid duplex on 12, 24 and 36 month. If there is coexisting contralateral carotid stenosis greater than 50% and not requiring interventional treatment (CEA or CAS), patient should cross in optimal medical therapy group.

Optimal medical therapy group: Patients not subjected to intervention (or in whom one carotid has been treated with CAS or CEA and contra-lateral stenosis is greater than 50%) will be followed with carotid duplex (at 12, 24 and 36 months) and MRI imaging of carotid tree from aortic arch up to the circle of Willis after 12 and 36 months.

Trial plans to recruit 270 patients distributed in participating centers based on individual capabilities of each center. The diagnostic performance of the new risk model, and its accuracy to discriminate high versus low risk cases for cerebrovascular complications from carotid artery disease will be evaluated using Receiver Operating Characteristic (ROC) curve analysis. The accuracy (discriminated ability) of the model will be assessed by measuring the Area under the ROC curve (AUC). An AUC 0.80 and 90% CI, for the sensitivity of prediction model of 80% with marginal error of 10%, will be targeted.

Trial will terminate after finalizing 36 months of follow up for included patients at June 2022.


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Study Type : Observational
Estimated Enrollment : 270 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Observational Multicentre Clinical Trial for Validation of Taxinomisis, New Stratification Tool for Stroke Risk in Patients With Carotid Disease
Actual Study Start Date : March 29, 2018
Estimated Primary Completion Date : June 1, 2022
Estimated Study Completion Date : September 1, 2022

Group/Cohort Intervention/treatment
Carotid endarterectomy
Patients that underwent intervention (CEA or CAS) are followed by clinical examination and carotid duplex on 12, 24 and 36 month If there is coexisting contralateral carotid stenosis with grade greater than 50% and not requiring interventional treatment (CEA or CAS), patient should cross in optimal medical therapy group.
Procedure: Carotid endarterectomy
Exploration of carotid bifurcation. Clamping of carotid artery and plaque removal with endarterectomy. Plaque is stored. Suture of artery with direct suture or patch.

Optimal medical therapy group
Patients not subjected to intervention (or in whom one carotid has been treated with CAS or CEA and contralateral has stenosis is greater than 50%) will be followed with carotid duplex (at 12, 24 and 36 months) and MRI imaging of carotid tree from aortic arch up to the circle of Willis after 12 and 36 months.
Procedure: Carotid endarterectomy
Exploration of carotid bifurcation. Clamping of carotid artery and plaque removal with endarterectomy. Plaque is stored. Suture of artery with direct suture or patch.




Primary Outcome Measures :
  1. Combined stroke, transitory ischemic attach and retinal transitory ischemic attach [ Time Frame: 3 years ]
    rapidly developing clinical signs of focal (or global) disturbance of cerebral function, lasting more than 24 hours or leading to death, with no apparent cause other than that of vascular origin with CT or MRI confirmation of ischemia


Secondary Outcome Measures :
  1. Silent brain lesions [ Time Frame: 3 years ]
    ischemic lesions in the brain


Biospecimen Retention:   Samples Without DNA

At the inclusion in study, after 12,24 and 36 months blood samples will be analyzed, while 10 ml of blood sample will be stored for further analysis.

Patients treated with carotid endarterectomy will have their plaque stored and analysed.



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Ages Eligible for Study:   40 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with extracranial carotid stenosis greater than 50% stenosis (NASCET) in the carotid bifurcation or internal carotid artery assessed by means of ultrasound
Criteria

Inclusion Criteria:

  • Extracranial carotid stenosis greater than 50% stenosis (NASCET) in the carotid bifurcation or internal carotid artery assessed by means of ultrasound;
  • Ability of the patient for follow-up examinations;
  • Personally signed informed consent

Exclusion Criteria:

  • Previous haemorrhagic stroke,
  • Non-atherosclerotic carotid stenosis (e.g. dissection, floating thrombus, fibromuscular dysplasia, postirradiation lesion)
  • Presence of stenotic lesions in the proximal common carotid artery,
  • Recurrent carotid stenosis after CEA or CAS,
  • Carotid aneurysm
  • Bilateral carotid occlusion,
  • Severe aortic arch calcifications and shaggy aorta
  • Intracranial angioma or aneurysms,
  • Severe pre-existing disability (modified Rankin scale ≥ 3);
  • Contraindications for heparin, ASA and clopidogrel therapy
  • Contraindication for MRI examination (metal implants, claustrophobia);
  • Increased risk of thrombotic or embolic events (congenital or acquired thrombotic conditions, active untreated cancer, atrial fibrillation, severe cardiomyopathy with ejection fraction lower than 30%);
  • Planned major surgery and/or life expectancy less than 3 years

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03495830


Contacts
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Contact: Themis Exarchos, PhD 00306947709387 themis.exarchos@gmail.com
Contact: Vassilisa Potsika, PhD vpotsika@gmail.com

Locations
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Germany
University of Munich Not yet recruiting
Munich, Germany
Contact: Jaroslav Pelisek       pelisek@gmx.de   
Netherlands
University of Utrecht Not yet recruiting
Utrecht, Netherlands
Contact: Gert Jan de Borst, PhD       G.J.deBorst-2@umcutrecht.nl   
Contact: Gerard Pasterkamp       g.pasterkamp@umcutrecht.nl   
Serbia
Clinic for Vascular and Endovascular Surgery, Serbian Clinical Centre Recruiting
Belgrade, Serbia, 11000
Contact: Igor Koncar, MD    +381668300290    dr.koncar@gmail.com   
Sub-Investigator: Igor Koncar, MD         
Spain
University of Barcelona Not yet recruiting
Barcelona, Spain
Contact: Vincente Riambau, PhD       VRIAMBAU@clinic.cat   
Contact: Gaspar Mestres, PhD       gasparmestres@gmail.com   
Sponsors and Collaborators
University of Belgrade
Ludwig-Maximilians - University of Munich
University of Barcelona
University of Athens
University of Genova
Utrecht University
Investigators
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Study Director: Dimitris Fotiadis, PhD University of Ionania

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Responsible Party: Igor Koncar, Vascular surgeon,PhD, MD, University of Belgrade
ClinicalTrials.gov Identifier: NCT03495830     History of Changes
Other Study ID Numbers: STRATIFY
755320 ( Other Grant/Funding Number: European Union's Horizon 2020 )
First Posted: April 12, 2018    Key Record Dates
Last Update Posted: July 23, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Carotid Stenosis
Carotid Artery Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases