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.
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.
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).
- Biomarkers serum level measurement Other
Intervention Desc: 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. ARM 1: Kind: Experimental Label: 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) ARM 2: Kind: Experimental Label: 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 ARM 3: Kind: Experimental Label: Control group Description: Healthy volunteers without ACAS Interventions to be administered:Biomarkers serum level measurement, history taking, neurological examination, duplex ultrasound, MMSE
- Observation: Cohort
- Perspective: Cross-Sectional
- Sampling: Non-Probability Sample
|Type||Measure||Time Frame||Safety Issue|
|Primary||Mean concentration of atherosclerosis biomarkers (LP-PL-A2, PAPP A, ADMA, hsCRP and blood lipid profile)||0 month||No|
|Primary||Mean concentration of Lipoprotein-associated Phospholipase A2 (LP-PL-A2)||0 month||No|
|Primary||Mean concentration of Pregnancy-associated Plasma Protein A (PAPP A)||0 month||No|
|Primary||Mean concentration of Asymmetric Dimethylarginine (ADMA)||0 month||No|
|Primary||Mean concentration of highsensitivity C-reactive Protein (hsCRP)||0 month||No|
|Primary||Mean concentration of Lipprotein (a)||0 month||No|
Biospecimen Retention:Samples With DNA - Blood serum