Clinical and Laboratory Biomarkers in Patients With Atherothrombotic Stroke "CLAST"

Recruiting

Phase N/A Results N/A

Trial Description

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).

Conditions

Interventions

  • 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

Trial Design

  • Observation: Cohort
  • Perspective: Cross-Sectional
  • Sampling: Non-Probability Sample

Trial Population

In-hospital patients

Outcomes

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

Sponsors