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

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ClinicalTrials.gov Identifier: NCT02360137
Recruitment Status : Recruiting
First Posted : February 10, 2015
Last Update Posted : March 16, 2018
Sponsor:
Collaborators:
General Teaching Hospital, Prague
Charles University, Czech Republic
Palacky University
Information provided by (Responsible Party):
University Hospital Ostrava

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.

Condition or disease
Carotid Artery Plaque

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 413 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Atherosclerotic Plaque Characteristics Associated With a Progression Rate of the Plaque and a Risk of Stroke in Patients With the carotId Bifurcation Plaque Study
Study Start Date : April 2015
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : June 2020

Group/Cohort
Patients with carotid plaque
Patients with carotid plaque treated using only drugs
Patients with carotid stenosis
Patients with carotid stenosis indicated to carotid endarterectomy



Primary Outcome Measures :
  1. Plaque progression [ Time Frame: 3 years ]
    Sonographic and histological characteristics associated with plaque progression


Secondary Outcome Measures :
  1. Sonographic plaque characteristics correlation [ Time Frame: 1 year ]
    Sonographic plaque characteristics correlation, using Spearman correlation coefficient to verify the existence of correlations between carotid atherosclerotic plaque in a B-mode in vivo (before endarterectomy) and subsequently in a B-mode in vitro (after endarterectomy) in homogeneity, composition, echogenity index, plaque surface type

  2. Histological and sonographic plaque characteristics correlation [ Time Frame: 1 year ]
    Histological and sonographic plaque characteristics correlation, using Spearman correlation coefficient to verify the existence of correlations between variables - homogeneity, composition, echogenity index, plaque surface type

  3. Stroke risk [ Time Frame: 3 years ]
    Sonographic and histological characteristics associated with stroke or TIA risks, such as homogeneity, composition, echogenity index, plaque surface type


Biospecimen Retention:   Samples Without DNA
atherosclerotic plaque


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Ages Eligible for Study:   30 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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.

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): NCT02360137


Contacts
Contact: David Skoloudik, MD, Prof. 420597375613 skoloudik@hotmail.com
Contact: Michal Bar, MD, PhD 420597375601 michal.bar@fno.cz

Locations
Czechia
University Hospital Ostrava Recruiting
Ostrava, Czech Republic, Czechia, 70852
Contact: David Skoloudik, MD, Prof.    00420597375613    skoloudik@hotmail.com   
Contact: Michal Bar, MD, PhD    00420597375601    michal.bar@fno.cz   
Principal Investigator: David Skoloudik, MD, Prof         
Sponsors and Collaborators
University Hospital Ostrava
General Teaching Hospital, Prague
Charles University, Czech Republic
Palacky University
Investigators
Study Chair: David Skoloudík, MD, Prof University Hospital Ostrava

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University Hospital Ostrava
ClinicalTrials.gov Identifier: NCT02360137     History of Changes
Other Study ID Numbers: 15-29410A
First Posted: February 10, 2015    Key Record Dates
Last Update Posted: March 16, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by University Hospital Ostrava:
carotids
plaque
characteristics
stroke

Additional relevant MeSH terms:
Carotid Stenosis
Plaque, Atherosclerotic
Pathological Conditions, Anatomical
Carotid Artery Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases