Clinical and Laboratory Biomarkers in Patients With Atherothrombotic Stroke

Stroke Clinical Trial

— CLAST  

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02450721
• Other study ID #: StPetersburgSPMU
• Status: Recruiting
• Phase: N/A
• First received: May 19, 2015
• Last updated: May 3, 2016
• Start date: January 2011
• Est. completion date: January 2018

Study information

• Verified date: May 2016
• Source: St. Petersburg State Pavlov Medical University
• Contact: Elena V. Melnikova, Ph.D.
• Phone: +79117431508
• Email: melnikovae2002[@]gmail.com
• Is FDA regulated: No
• Health authority: Russia: Ministry of Health of the Russian Federation
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 97
• Est. completion date: January 2018
• Est. primary completion date: January 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years to 80 Years

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Carotid Artery Diseases
• Stroke

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Russian Federation	StPetersburgSPMU	Saint Petersburg

Sponsors (1)

Lead Sponsor	Collaborator
St. Petersburg State Pavlov Medical University

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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