Clinical trial NCT02450721: Clinical and Laboratory Biomarkers in Patients With Atherothrombotic Stroke
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Carotid Artery Diseases
Stroke
Keywords: atherosclerosis
biomarkers
carotid artery stenosis
ischemic stroke.
Lead sponsor: St. Petersburg State Pavlov Medical University
Sponsor class: OTHER
First posted: 2015-05-21
Enrollment: 97
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: In-hospital patients

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).

Eligibility 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

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.

Control group

Inclusion Criteria:

* intima media thickness less then 1mm
* no history of stroke/TIAs

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.

Primary outcomes:
measure: Mean concentration of Lipoprotein-associated Phospholipase A2 (LP-PL-A2)
timeFrame: 0 month
measure: Mean concentration of Pregnancy-associated Plasma Protein A (PAPP A)
timeFrame: 0 month
measure: Mean concentration of Asymmetric Dimethylarginine (ADMA)
timeFrame: 0 month
measure: Mean concentration of highsensitivity C-reactive Protein (hsCRP)
timeFrame: 0 month
measure: Mean concentration of Lipprotein (a)
timeFrame: 0 month
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Petersburg
country: Russian Federation
facility: StPetersburgSPMU
Study officials:
References: