Clinical trial NCT02126280: Monocyte Activation in Preclinical Atherosclerosis
Official title: Cross-sectional Clinical Study of the Individual Profile of Activation of Circulating Blood Monocytes in Subjects With Preclinical Atherosclerosis.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atherosclerosis
Keywords: proinflammatory cytokines
anti-inflammatory cytokines
human monocytes
activation
biomarkers
asymptomatic atherosclerosis
Lead sponsor: Institute for Atherosclerosis Research, Russia
Sponsor class: OTHER
First posted: 2014-04-30
Enrollment: 170
Sex: ALL
Minimum age (years): 40
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The inclusion of healthy individuals, of apparently healthy persons with a predisposition to atherosclerosis, and subjects with subclinical atherosclerosis, according to the results of ultrasonographic examination of carotids, to achieve 80% statistical power (up to 50 study participants per group).

Conducting experiments on obtaining the individual cultures of blood monocytes and stimulation of cells by proinflammatory and anti-inflammatory stimuli

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Development and optimization of the method of monocyte-macrophage isolation.
timeFrame: up to 1 years
Secondary outcomes:
measure: Sample processing and parameter measurements.
timeFrame: up to 1 years
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Institute for Atherosclerosis Research
Study officials:
affiliation: Institute for Atherosclerosis Research
name: Alexander N Orekhov, PhD, DSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.