Stratification of Patient With Carotid Disease

NCT03495830 | Completed DMC

• 2 other identifiers: STRATIFY755320
• Study Type: observational
• Target: 270
• Locations: 4 countries
• Sites: 4

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.

Conditions

Carotid Artery Stenosis

Outcome Measures

Primary Outcomes (1)

• Combined stroke, transitory ischemic attach and retinal transitory ischemic attach

  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

  3 years

Secondary Outcomes (1)

• Silent brain lesions

  3 years

Study Arms (2)

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

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

Interventions

Carotid endarterectomy PROCEDURE

Exploration of carotid bifurcation. Clamping of carotid artery and plaque removal with endarterectomy. Plaque is stored. Suture of artery with direct suture or patch.

Carotid endarterectomy; Optimal medical therapy group

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Belgrade: lead
• Ludwig-Maximilians - University of Munich: collaborator
• University of Barcelona: collaborator
• University of Athens: collaborator
• University of Genova: collaborator
• Utrecht University: collaborator

Study Sites (4)

University of Munich

Munich, Germany

Location

University of Utrecht

Utrecht, Netherlands

Location

Clinic for Vascular and Endovascular Surgery, Serbian Clinical Centre

Belgrade, Serbia, 11000, Serbia

Location

University of Barcelona

Barcelona, Spain

Location

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.

MeSH Terms

Conditions

Carotid Stenosis

Interventions

Endarterectomy, Carotid

Condition Hierarchy (Ancestors)

Carotid Artery Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Endarterectomy; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Dimitris Fotiadis, PhD

  University of Ionania

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vascular surgeon,PhD, MD

Study Record Dates

• First Submitted: March 21, 2018
• First Posted: April 12, 2018
• Study Start: March 29, 2018
• Primary Completion: June 1, 2022
• Study Completion: September 1, 2022
• Last Updated: April 6, 2025

Record last verified: 2022-01

Locations

NL (1); ES (1); DE (1); SE (1)