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Atherosclerotic plaque characteristics associated with a progression rate of the plaque and a risk of stroke in patients with the carotId bifurcation plaque study

NCT ID NCT02360137

NEW Sponsor: University Hospital Ostrava Source: ClinicalTrials.gov ↗

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Recruiting now
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By invitation only
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Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

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Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

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Status unknown
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First seen Sep 09, 2026 · Last updated Sep 09, 2026

Summary

Atherosclerosis is the most common cause of stroke. The aims of the project are to compare the visual and digital analysis of sonographic images of atherosclerotic plaque in carotids in vivo, in vitro and with a histological composition of the plaque obtained from patients indicated to carotid endarterectomy, to compare the characteristics of symptomatic and asymptomatic atherosclerotic plaques and, subsequently to verify a hypothesis that ultrasound can identify the sonographic plaque characteristics associated with an increased risk of plaque progression and of ischemic stroke (unstable plaque) in patients with carotid atherosclerosis. Identifying of the sonographic characteristics of unstable plaque will allow to improve indication criteria for carotid endarterectomy or stenting and also potential changing of a drug therapy in patients with unstable plaque in the future. Cost efficiency and availability of duplex ultrasound equipment may enable to improve diagnosis of unstable plaque using this new plaque characteristics evaluation in the majority of patients with carotid plaques. Secondary aim is to evaluate prevalence of carotid web and risk of stroke in patients with atherosclerotic plaque in carotid arteries and healthy population.

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Study facts

What this study's own registry entry says, in plain language.

Participants

1,863 people

The number who actually took part.

Started

Apr 2015

Finished

Jun 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

The project follow-up period for each enrolled patient will take 10 years. Total of 1863 patients with atherosclerotic plaque in carotid arteries and 250 healthy controls will be included to the study. In the substudy, total of 413 patients with atherosclerotic plaques in the carotid bifurcation and internal carotid artery causing arterial stenosis ≥ 30% detected by duplex sonography will be included to the study - 152 patients indicated for carotid endarterectomy according to the currently valid guidelines (American Heart Association/American Stroke Association \[AHA\], European Stroke Organisation \[ESO\]) and 261 patients indicated for conservative treatment. Patients will be screened and enrolled in sonographic laboratories of the Military University Hospital in Prague and University Hospital Ostrava.

Ages

18 to 90 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * age 30 - 90 years * sufficient image quality of atherosclerotic plaque in the carotid bifurcation and ICA using ultrasound * independency of the patient (0 - 2 points in the modified Rankin scale) * signed informed consent. Exclusion Criteria: * serious disease with a low probability of survival of at least 3 years * other objective obstacles preventing regular 6-month ultrasound scan.

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Conditions

The condition(s) this trial relates to.

carotid stenosis carotid web Plaque, Amyloid stroke disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Carotid artery plaque Carotid web

Contacts and locations

Locations

  • University Hospital Ostrava

    Ostrava, Czech Republic, 70852, Czechia

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