Clinical and Laboratory Biomarkers in Patients With Atherothrombotic Stroke (CLAST)

May 3, 2016 updated by: St. Petersburg State Pavlov Medical University
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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).

Study Type

Observational

Enrollment (Anticipated)

97

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

In-hospital patients

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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)
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.
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
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.
Control group
Healthy volunteers without ACAS Interventions to be administered:Biomarkers serum level measurement, history taking, neurological examination, duplex ultrasound, MMSE
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mean concentration of Lipoprotein-associated Phospholipase A2 (LP-PL-A2)
Time Frame: 0 month
0 month
Mean concentration of Pregnancy-associated Plasma Protein A (PAPP A)
Time Frame: 0 month
0 month
Mean concentration of Asymmetric Dimethylarginine (ADMA)
Time Frame: 0 month
0 month
Mean concentration of highsensitivity C-reactive Protein (hsCRP)
Time Frame: 0 month
0 month
Mean concentration of Lipprotein (a)
Time Frame: 0 month
0 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St. Petersburg State Pavlov Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Actual)

January 1, 2015

Study Completion (Anticipated)

January 1, 2018

Study Registration Dates

First Submitted

May 19, 2015

First Submitted That Met QC Criteria

May 19, 2015

First Posted (Estimate)

May 21, 2015

Study Record Updates

Last Update Posted (Estimate)

May 4, 2016

Last Update Submitted That Met QC Criteria

May 3, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • StPetersburgSPMU

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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