Clinical and Laboratory Biomarkers in Patients With Atherothrombotic Stroke (CLAST)

St. Petersburg State Pavlov Medical University

Status: Unknown

Conditions: Stroke; Carotid Artery Diseases

Treatments: Other: Biomarkers serum level measurement

Study type: Observational

Funder types: Other

Identifiers

NCT02450721

StPetersburgSPMU

Details and patient eligibility

About

Aim of the present study is to investigate molecular and clinical markers in patients with atherosclerotic carotid stenosis (ACAS) in the ischemic stroke acute phase.

Full description

Background: Laboratory biomarkers of atherosclerosis can be valuable in decision about operative treatment in patients with mild to severe atherosclerotic carotid stenosis (ACAS) and high stroke risk. However nowadays there are no established instruments for personalized atherothrombotic stroke diagnostics. Aim of the present study was to access atherosclerosis biomarkers serum levels in patients with ACAS during the ischemic stroke/ transient ischemic attack (TIA) acute phase.

Main objective of the study To explore informative biomarkers to determine the risk of stroke in patients with significant ACAS.

Secondary objectives

1. To investigate the association between the degree of neurological and cognitive deficits , the features of the disease , the severity of brain lesions according to neuroimaging data with the concentration of lipoprotein -associated phospholipase A2 (LP-PL-A2), high sensitive C- reactive protein (hsCRP) , pregnancy-associated plasma protein A (PAPP-A), asymmetric dimethylarginine (ADMA), lipoprotein (a) in patients with atherothrombotic stroke.
2. To find the most valuable laboratory biomarkers of atherosclerosis , to compare them with clinical and objective data to make decision about inclusion of these biomarkers in routine practice as a screening test of atherosclerotic plaque instability and for stroke risk prediction and in decision about operative treatment in patients with ACAS.

Design and Methods A single-blind cross-sectional trial was performed to investigate laboratory biomarkers of atherosclerosis in patients with atherosclerotic stenosis of the internal carotid artery 50-99 % , and in healthy volunteers. Randomizing and blinding technique: laboratory scientist and statistician do not have information about the belonging of biomaterials patient to any of the groups studied .

Examination of patients includes history taking, neurological examination, duplex ultrasound, mini mental score examination (MMSE), enzyme-linked immunosorbent assay (ELISA) performed atherosclerosis biomarkers serum level measurement (LP-PL-A2, PAPP-A, ADMA, hsCRP and blood lipid profile).

Enrollment: 97 estimated patients

Sex: All

Ages: 50 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Acute stroke

Inclusion Criteria:

• 50-99% atherosclerotic carotid artery stenosis
• Acute atherothrombotic stroke/TIA (according to TOAST-criteria) within the first 3 days after vascular event

Exclusion Criteria:

• risk factors of non-atherothrombotic stroke (according to TOAST-criteria)
• cancer
• exacerbation of decompensated chronic diseases
• infections
• acute cardiovascular diseases
• large operation during 1 month before enrollment
• Cortexin, Actovegin, Cerebrolysin, Erythropoetin administration during 1 week before enrollment.

Stable ACAS

Inclusion Criteria:

• 50-99% atherosclerotic carotid artery stenosis
• no history of vascular events during one month before enrollment

Exclusion Criteria:

• risk factors of non-atherothrombotic stroke (according to TOAST-criteria)
• cancer
• exacerbation of decompensated chronic diseases
• infections
• acute cardiovascular diseases
• large operation during 1 month before enrollment
• Cortexin, Actovegin, Cerebrolysin, Erythropoetin administration during 1 week before enrollment.

Control group

Inclusion Criteria:

• intima media thickness less then 1mm
• no history of stroke/TIAs

Exclusion Criteria:

• risk factors of non-atherothrombotic stroke (according to TOAST-criteria)
• cancer
• exacerbation of decompensated chronic diseases
• infections
• acute cardiovascular diseases
• large operation during 1 month before enrollment
• Cortexin, Actovegin, Cerebrolysin, Erythropoetin administration during 1 week before enrollment.

Trial design

97 participants in 3 patient groups

Acute stroke

Description:

Patients in the acute phase of atherothrombotic stroke or TIAs with 50-99% ACAS within the first 3 days af vascular event. Interventions to be administered: Biomarkers serum level measurement, history taking, neurological examination, duplex ultrasound, MMSE, National Institutes of Health Stroke Scale (NIHSS)

Treatment:

Other: Biomarkers serum level measurement

Stable carotid artery stenosis

Description:

Patients with 50-99% ACAS without history of vascular events during one month before enrollment. Interventions to be administered: Biomarkers serum level measurement, history taking, neurological examination, duplex ultrasound, MMSE

Treatment:

Other: Biomarkers serum level measurement

Control group

Description:

Healthy volunteers without ACAS Interventions to be administered:Biomarkers serum level measurement, history taking, neurological examination, duplex ultrasound, MMSE

Treatment:

Other: Biomarkers serum level measurement