Atherosclerotic Plaque Characteristics Associated With a Progression Rate of the Plaque in Carotids and a Risk of Stroke

NCT02360137 | Active Not Recruiting

• 1 other identifier: 15-29410A
• Study Type: observational
• Target: 1,863
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Carotid Artery Plaque

Keywords

carotids; plaque; characteristics; stroke

Outcome Measures

Primary Outcomes (1)

• Plaque progression

  Sonographic and histological characteristics associated with plaque progression

  10 years

Secondary Outcomes (4)

• Stroke risk

  10 years

• Mortality

  10 years

• Sonographic plaque characteristics correlation

  1 year

• Histological and sonographic plaque characteristics correlation

  1 year

Study Arms (2)

Patients with carotid plaque

Patients with carotid plaque treated using only drugs

Patients with carotid stenosis

Patients with carotid stenosis indicated to carotid endarterectomy

Eligibility Criteria

• Age: 30 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The project period will take 54 months. 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.

You may qualify if:

• 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.

You may not qualify if:

• serious disease with a low probability of survival of at least 3 years
• other objective obstacles preventing regular 6-month ultrasound scan.

Sponsors & Collaborators

• University Hospital Ostrava: lead
• General Teaching Hospital, Prague: collaborator
• Charles University, Czech Republic: collaborator
• Palacky University: collaborator
• Military University Hospital, Prague: collaborator
• University of Ostrava: collaborator
• Masaryk Hospital Usti nad Labem: collaborator
• University Hospital Hradec Kralove: collaborator
• Na Homolce Hospital: collaborator
• University Hospital Olomouc: collaborator

Study Sites (1)

University Hospital Ostrava

Ostrava, Czech Republic, 70852, Czechia

Location

Related Publications (3)

• Pakizer D, Salounova D, Skoloudik D. Extracranial carotid plaque calcification and its association with risk factors for cerebrovascular events: insights from the ANTIQUE study. Front Neurol. 2025 Jan 29;16:1532883. doi: 10.3389/fneur.2025.1532883. eCollection 2025.

  PMID: 39944551 DERIVED

• Skoloudik D, Kesnerova P, Hrbac T, Netuka D, Vomacka J, Langova K, Herzig R, Belsan T. Risk factors for carotid plaque progression after optimising the risk factor treatment: substudy results of the Atherosclerotic Plaque Characteristics Associated with a Progression Rate of the Plaque and a Risk of Stroke in Patients with the carotid Bifurcation Plaque Study (ANTIQUE). Stroke Vasc Neurol. 2022 Apr;7(2):132-139. doi: 10.1136/svn-2021-001068. Epub 2021 Dec 1.

  PMID: 34853082 DERIVED

• Fadrna T, Miksova Z, Herzig R, Langova K, Licman L, Skoloudik D. Factors influencing quality of life in patients followed in the neurosonology laboratory for carotid stenosis. Health Qual Life Outcomes. 2018 Apr 27;16(1):79. doi: 10.1186/s12955-018-0902-2.

  PMID: 29703211 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

atherosclerotic plaque

MeSH Terms

Conditions

Carotid Stenosis; Plaque, Amyloid; Stroke

Condition Hierarchy (Ancestors)

Carotid Artery Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• David Skoloudík, MD, Prof

  University Hospital Ostrava

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2015
• First Posted: February 10, 2015
• Study Start: April 1, 2015
• Primary Completion: January 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: July 28, 2023

Record last verified: 2023-07

Locations

CZ (1)