Clinical and Laboratory Biomarkers in Patients With Atherothrombotic Stroke
NCT ID: NCT02450721
Last Updated: 2016-05-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
97 participants
OBSERVATIONAL
2011-01-31
2018-01-31
Brief Summary
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Detailed Description
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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
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Study Design
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COHORT
CROSS_SECTIONAL
Study Groups
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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)
Biomarkers 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.
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
Biomarkers 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.
Control group
Healthy volunteers without ACAS Interventions to be administered:Biomarkers serum level measurement, history taking, neurological examination, duplex ultrasound, MMSE
Biomarkers 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.
Interventions
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Biomarkers 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.
Eligibility Criteria
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Inclusion Criteria
* Acute atherothrombotic stroke/TIA (according to TOAST-criteria) within the first 3 days after vascular event
* 50-99% atherosclerotic carotid artery stenosis
* no history of vascular events during one month before enrollment
* intima media thickness less then 1mm
* no history of stroke/TIAs
Exclusion 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
* 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
* 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.
50 Years
80 Years
ALL
Yes
Sponsors
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St. Petersburg State Pavlov Medical University
OTHER
Responsible Party
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Locations
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StPetersburgSPMU
Saint Petersburg, Sankt-Peterburg, Russia
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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StPetersburgSPMU
Identifier Type: -
Identifier Source: org_study_id
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