Monocyte Activation in Preclinical Atherosclerosis

NCT ID: NCT02126280

Last Updated: 2014-04-30

Study Results

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

170 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-11-30

Study Completion Date

2014-04-30

Brief Summary

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The study of proinflammatory and anti-inflammatory cytokines and chemokines expression profiles in human monocytes to identify new effective biomarkers that have the best diagnostic potential in asymptomatic atherosclerosis.

Detailed Description

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This project is the first step in creating a method for assessing an individual activity of macrophages. The problems addressed in the project are socially significant because of the high incidence of life-threatening diseases and their effects in the population. The method of evaluation of monocyte-macrophages activity in human blood will be based on the analysis of expression of cytokines and chemokines - markers of inflammatory and anti-inflammatory activity of macrophages. The most informative panel of cytokines and chemokines obtained during the project can be further used to create effective diagnostic tests.

Conditions

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Atherosclerosis

Keywords

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proinflammatory cytokines anti-inflammatory cytokines human monocytes activation biomarkers asymptomatic atherosclerosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Subclinical atherosclerosis

In vitro estimation of individual reactivity of monocytes in study participants with asymptomatic atherosclerotic plaques found in carotid arteries by ultrasound examination

In vitro estimation of individual reactivity of monocytes

Intervention Type OTHER

Technique for isolation/separation of monocytes with culture purity more than 95 % CD14-positive cells according to flow cytometry, the share of viable cells at least 98% by trypan blue vital staining, capable of producing TNFa at concentration of at least 50 pg/ml when stimulated with 100 ng/ml IFN-gamma, and CCL18 at concentration at least 30 pg/ml when stimulated with 10 ng/ml interleukin.

Healthy subjects

In vitro estimation of individual reactivity of monocytes in study participants without ultrasound signs of subclinical carotid atherosclerosis

In vitro estimation of individual reactivity of monocytes

Intervention Type OTHER

Technique for isolation/separation of monocytes with culture purity more than 95 % CD14-positive cells according to flow cytometry, the share of viable cells at least 98% by trypan blue vital staining, capable of producing TNFa at concentration of at least 50 pg/ml when stimulated with 100 ng/ml IFN-gamma, and CCL18 at concentration at least 30 pg/ml when stimulated with 10 ng/ml interleukin.

Diffuse intimal thickening

In vitro estimation of individual reactivity of monocytes in study participants with diffuse intima-media thickening of carotid arteries found at ultrasound examination

In vitro estimation of individual reactivity of monocytes

Intervention Type OTHER

Technique for isolation/separation of monocytes with culture purity more than 95 % CD14-positive cells according to flow cytometry, the share of viable cells at least 98% by trypan blue vital staining, capable of producing TNFa at concentration of at least 50 pg/ml when stimulated with 100 ng/ml IFN-gamma, and CCL18 at concentration at least 30 pg/ml when stimulated with 10 ng/ml interleukin.

Interventions

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In vitro estimation of individual reactivity of monocytes

Technique for isolation/separation of monocytes with culture purity more than 95 % CD14-positive cells according to flow cytometry, the share of viable cells at least 98% by trypan blue vital staining, capable of producing TNFa at concentration of at least 50 pg/ml when stimulated with 100 ng/ml IFN-gamma, and CCL18 at concentration at least 30 pg/ml when stimulated with 10 ng/ml interleukin.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* men and women aged 40 to 74 years
* arterial normotension or mild arterial hypertension (systolic blood pressure \<160 mm Hg, diastolic blood pressure \<90 mm Hg)
* absence of chronic diseases demanding permanent drug administration (more than 2 month per year)

Exclusion Criteria

* personal history of transient ischemic attacks
* personal history of chronic diseases demanding permanent drug administration (more than 2 month per year)
* personal history of life-threatening diseases
* indications for surgical treatment of atherosclerotic lesions localized in the extracranial brachiocephalic system
Minimum Eligible Age

40 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Institute for Atherosclerosis Research, Russia

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alexander N Orekhov, PhD, DSc

Role: PRINCIPAL_INVESTIGATOR

Institute for Atherosclerosis Research

Locations

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Institute for Atherosclerosis Research

Moscow, , Russia

Site Status

Countries

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Russia

References

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Gratchev A, Ovsiy I, Manousaridis I, Riabov V, Orekhov A, Kzhyshkowska J. Novel monocyte biomarkers of atherogenic conditions. Curr Pharm Des. 2013;19(33):5859-64. doi: 10.2174/1381612811319330004.

Reference Type BACKGROUND
PMID: 23438959 (View on PubMed)

Gratchev A, Sobenin I, Orekhov A, Kzhyshkowska J. Monocytes as a diagnostic marker of cardiovascular diseases. Immunobiology. 2012 May;217(5):476-82. doi: 10.1016/j.imbio.2012.01.008. Epub 2012 Jan 13.

Reference Type BACKGROUND
PMID: 22325375 (View on PubMed)

Other Identifiers

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IAR-MAPA

Identifier Type: -

Identifier Source: org_study_id