Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Secondary objectives
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).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acute stroke | 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) |
| |
| Stable carotid artery stenosis | 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 |
| |
| Control group | Healthy volunteers without ACAS Interventions to be administered:Biomarkers serum level measurement, history taking, neurological examination, duplex ultrasound, MMSE |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biomarkers serum level measurement | Other | 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. |
| Measure | Description | 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 |
Not provided
Not provided
Acute stroke
Inclusion Criteria:
Exclusion Criteria:
Stable ACAS
Inclusion Criteria:
Exclusion Criteria:
Control group
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
In-hospital patients
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Elena V. Melnikova, Ph.D. | Contact | +79117431508 | melnikovae2002@gmail.com | |
| Alexey A. Shmonin, Ph.D. | Contact | +79213568136 | langendorff@gmail.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| StPetersburgSPMU | Recruiting | Saint Petersburg | Sankt-Peterburg | 197022 | Russia |
Not provided
| ID | Term |
|---|---|
| D002340 | Carotid Artery Diseases |
| D020521 | Stroke |
| D050197 | Atherosclerosis |
| D016893 | Carotid Stenosis |
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Blood serum
|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |