Carotid Artery Diseases, Stroke
Conditions
Keywords
atherosclerosis, biomarkers, carotid artery stenosis, ischemic stroke.
Brief summary
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.
Detailed 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).
Interventions
OTHERBiomarkers serum level measurement
Biomarker serum level measurement was performed with ELISA using following kits: Lp-PL-A2 ELISA- Cloud-CloneCorp. (USA); PAPP-A ELISA- IBL (Germany); Lp (a) ELISA Kit-AssayPro (USA ), ADMA ELISA Kit- ImmunDiagnostik ( Germany); hsCRP ELISA- Biomerica (Germany); according to the manufacturer's instructions . Absorbance of standards and samples was measured with a microplate reader Bio-Tek (USA) at a wavelength specified by the kit manufacturer . The calculation of the determined biomarkers concentration was performed using the software SOFTmaxPRO.
Sponsors
St. Petersburg State Pavlov Medical University
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
50 Years to 80 Years
Healthy volunteers
Yes
Inclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean concentration of Lipoprotein-associated Phospholipase A2 (LP-PL-A2) | 0 month |
| Mean concentration of Pregnancy-associated Plasma Protein A (PAPP A) | 0 month |
| Mean concentration of Asymmetric Dimethylarginine (ADMA) | 0 month |
| Mean concentration of highsensitivity C-reactive Protein (hsCRP) | 0 month |
| Mean concentration of Lipprotein (a) | 0 month |
Countries
Russia
Contacts
Primary ContactElena V. Melnikova, Ph.D.
Backup ContactAlexey A. Shmonin, Ph.D.
Outcome results
None listed